| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00736 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| RTOG-0615 | |||
| CDR0000518526 | |||
| RTOG 0615 | Other Identifier | Radiation Therapy Oncology Group | |
| RTOG-0615 | Other Identifier | CTEP | |
| U10CA021661 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Radiation Therapy Oncology Group | NETWORK |
This phase II trial is studying how well giving bevacizumab together with cisplatin, radiation therapy, and fluorouracil works in treating patients with stage IIB, stage III, stage IVA, or stage IVB nasopharyngeal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of nasopharyngeal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with chemotherapy and radiation therapy may kill more tumor cells.
PRIMARY OBJECTIVES:
I. Determine the safety and tolerability of bevacizumab and chemoradiotherapy comprising cisplatin and radiotherapy followed by adjuvant therapy comprising cisplatin, fluorouracil, and bevacizumab in patients with stage IIB-IVB nasopharyngeal cancer.
SECONDARY OBJECTIVES:
I. Determine the 1- and 2-year rates of locoregional progression-free in patients treated with this regimen.
II. Determine the 1- and 2-year rates of distant metastases-free in patients treated with this regimen.
III. Determine the 1- and 2-year rates of progression-free and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.
ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1 OR days 1 and 2, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (bevacizumab, cisplatin, fluorouracil, IMRT, 3D-CRT) | Experimental | BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1 OR days 1 and 2, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-Dimensional Conformal Radiation Therapy | Radiation | Undergo 3D-CRT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With a Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year. | Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | From start of treatment to one year. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment After the First Year. | Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. |
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Inclusion Criteria:
Histologically confirmed cancer of the nasopharynx based on biopsy of a primary lesion and/or lymph nodes
Stage IIB-IVB disease
No distant metastases
Zubrod performance status 0-1
WBC ? 4,000/mm?
Hemoglobin ? 9.0 g/dL
Platelet count ? 100,000/mm?
Absolute neutrophil count ? 1,500/mm?
INR ? 1.5
aPTT ? 1.5 times upper limit of normal (ULN)
Alkaline phosphatase ? 1.5 times ULN
ALT and AST ? 1.5 times ULN
Bilirubin ? 1.5 times ULN
Creatinine ? 1.5 mg/dL OR creatinine clearance ? 55 mL/min
Urine protein:creatinine (UPC) ratio < 1.0
Hearing loss primarily sensorineural in nature and requiring a hearing aid or intervention that interferes in a clinically significant way with activities of daily living allowed
Conductive hearing loss from tumor-related otitis media is allowed
No severe, active comorbidity, including any of the following:
No gross hemoptysis or hematemesis, defined as bright red blood of ? 1 teaspoon per coughing episode, within the last 4 weeks (incidental blood mixed with phlegm allowed)
No other invasive malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
Nutritional and physical condition considered suitable for study treatment
No significant traumatic injury within the past 4 weeks
No history of allergic reaction to the study drugs
No baseline blood pressure > 150/100 mm Hg
No peripheral neuropathy ? grade 2
Not pregnant or nursing
Negative serum pregnancy test
Fertile patients must use effective contraception during and for ? 6 months after completion of study treatment
At least 10 days since prior and no concurrent dipyridamole, ticlopidine, clopidogrel bisulfate, cilostazol, warfarin, heparin, daily treatment with acetylsalicylic acid (> 325 mg/day), or nonsteroidal anti-inflammatory medications known to inhibit platelet function
No prior head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies
More than 1 week since prior fine-needle aspirations or placement of percutaneous gastrostomy tube
More than 4 weeks since prior major surgical procedures
No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
No prior bevacizumab or other vascular endothelial growth factor-targeting agents
No prior systemic chemotherapy for the study cancer
No concurrent hematologic growth factors (e.g. filgrastim [G-CSF], darbepoetin alfa, epoetin alfa) during study chemoradiotherapy
No concurrent prophylactic growth factors for neutropenia during study adjuvant therapy
No concurrent prophylactic amifostine or pilocarpine
No other concurrent experimental therapeutic cancer treatments
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Lee | Radiation Therapy Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | United States | ||
| Sutter Cancer Centers Radiation Oncology Services-Auburn |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37266942 | Derived | Lee NY, Harris J, Kim J, Garden A, Mechalakos J, Pfister DG, Chan ATC, Hu K, Colevas AD, Frank S, Shenouda G, Bar-Ad V, Waldron JN, Harari PM, Raben A, Torres-Saavedra P, Le QT. Long-term Outcomes of Bevacizumab and Chemoradiation for Locoregionally Advanced Nasopharyngeal Carcinoma: A Nonrandomized Controlled Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2316094. doi: 10.1001/jamanetworkopen.2023.16094. | |
| 22178121 | Derived | Lee NY, Zhang Q, Pfister DG, Kim J, Garden AS, Mechalakos J, Hu K, Le QT, Colevas AD, Glisson BS, Chan AT, Ang KK. Addition of bevacizumab to standard chemoradiation for locoregionally advanced nasopharyngeal carcinoma (RTOG 0615): a phase 2 multi-institutional trial. Lancet Oncol. 2012 Feb;13(2):172-80. doi: 10.1016/S1470-2045(11)70303-5. Epub 2011 Dec 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) | BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Bevacizumab | Biological | Given IV |
|
|
| Cisplatin | Drug | Given IV |
|
|
| Fluorouracil | Drug | Given IV |
|
|
| Intensity-Modulated Radiation Therapy | Radiation | Undergo IMRT |
|
|
| Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from day 366 to death or study termination whichever occurs first, up to 3.6 years. |
| Patient Tolerability to Each Component (Concurrent and Adjuvant) of the Protocol Treatment Regimen | Evaluated in terms of protocol treatment delivery. For concurrent treatment, measured by the percentage of patients who received 2 or more cycles of cisplatin (CDDP) and bevacizumab (BV) during concurrent treatment with radiation therapy(RT) and who had RT scored by the study chair as no variation or minor variation. For adjuvant treatment, measured by the percentage of patients who received 2 or more cycles of CDDP and 5-FU and BV during the adjuvant treatment phase. Estimated using a binomial distribution along with their associated 95% confidence intervals. | From start of treatment to end of treatment (approximately day 109). |
| Death During or Within 30 Days of Discontinuation of Protocol Treatment. | The percentage of patients dying during protocol treatment or within 30 days after the end of treatment. Estimated using a binomial distribution along with associated 95% confidence interval. | From start of treatment to 30 days after end of treatment (treatment ends approximately day 109). |
| One- and Two-year Distant Metastases-free Rates | Distant metastasis is defined as clear evidence of distant metastases (lung, bone, brain, etc.); biopsy is recommended where possible. Distant metastasis-free rate estimated by cumulative incidence method with death considered a competing risk. | From registration to two years |
| One- and Two-year Loco-regional Progression-free Rates | Loco-regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Local-regional progression-free rate estimated by cumulative incidence with death considered a competing risk. | Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years. |
| One- and Two-year Progression-free Survival Rates | Progression-free survival rate estimated by Kaplan-Meier method along with 95% confidence interval. An event is loco-regional or distant progression, or death due to any cause. Loco-regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as distant metastases. | Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years. |
| One- and Two-year Overall Survival Rates | Overall survival rate estimated by Kaplan-Meier method along with 95% confidence interval. An event is death due to any cause. | Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years. |
| Percentage of Patients With Other Grade 3-5 Adverse Events Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment | Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from start of treatment to death or study termination whichever occurs first, up to 3.6 years. |
| Auburn |
| California |
| 95603 |
| United States |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | 91505 | United States |
| Sutter Cancer Centers Radiation Oncology Services-Cameron Park | Cameron Park | California | 95682 | United States |
| Mercy San Juan Medical Center | Carmichael | California | 95608 | United States |
| East Bay Radiation Oncology Center | Castro Valley | California | 94546 | United States |
| Eden Hospital Medical Center | Castro Valley | California | 94546 | United States |
| Valley Medical Oncology Consultants-Castro Valley | Castro Valley | California | 94546 | United States |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States |
| Bay Area Breast Surgeons Inc | Emeryville | California | 94608 | United States |
| Valley Medical Oncology Consultants-Fremont | Fremont | California | 94538 | United States |
| Contra Costa Regional Medical Center | Martinez | California | 94553-3156 | United States |
| Highland General Hospital | Oakland | California | 94602 | United States |
| Alta Bates Summit Medical Center - Summit Campus | Oakland | California | 94609 | United States |
| Bay Area Tumor Institute | Oakland | California | 94609 | United States |
| Hematology and Oncology Associates-Oakland | Oakland | California | 94609 | United States |
| Tom K Lee Inc | Oakland | California | 94609 | United States |
| Stanford Cancer Institute Palo Alto | Palo Alto | California | 94304 | United States |
| Valley Care Health System - Pleasanton | Pleasanton | California | 94588 | United States |
| Valley Medical Oncology Consultants | Pleasanton | California | 94588 | United States |
| Sutter Cancer Centers Radiation Oncology Services-Roseville | Roseville | California | 95661 | United States |
| Sutter Medical Center Sacramento | Sacramento | California | 95816 | United States |
| Mercy General Hospital Radiation Oncology Center | Sacramento | California | 95819 | United States |
| Doctors Medical Center- JC Robinson Regional Cancer Center | San Pablo | California | 94806 | United States |
| Sutter Cancer Centers Radiation Oncology Services-Vacaville | Vacaville | California | 95687 | United States |
| Beebe Medical Center | Lewes | Delaware | 19958 | United States |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | United States |
| Boca Raton Regional Hospital | Boca Raton | Florida | 33486 | United States |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | United States |
| Integrated Community Oncology Network-Southside Cancer Center | Jacksonville | Florida | 32207 | United States |
| Baptist Medical Center South | Jacksonville | Florida | 32258 | United States |
| Integrated Community Oncology Network-Florida Cancer Center Beaches | Jacksonville Beach | Florida | 32250 | United States |
| Baptist Hospital of Miami | Miami | Florida | 33176 | United States |
| 21st Century Oncology-Orange Park | Orange Park | Florida | 32073 | United States |
| UF Cancer Center at Orlando Health | Orlando | Florida | 32806 | United States |
| 21st Century Oncology-Palatka | Palatka | Florida | 32177 | United States |
| Integrated Community Oncology Network-Flager Cancer Center | Saint Augustine | Florida | 32086 | United States |
| Memorial University Medical Center | Savannah | Georgia | 31404 | United States |
| John H Stroger Jr Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Saint Vincent Anderson Regional Hospital/Cancer Center | Anderson | Indiana | 46016 | United States |
| Union Hospital of Cecil County | Elkton | Maryland | 21921 | United States |
| Bronson Battle Creek | Battle Creek | Michigan | 49017 | United States |
| Spectrum Health Big Rapids Hospital | Big Rapids | Michigan | 49307 | United States |
| Cancer Research Consortium of West Michigan NCORP | Grand Rapids | Michigan | 49503 | United States |
| Mercy Health Saint Mary's | Grand Rapids | Michigan | 49503 | United States |
| Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | 49503 | United States |
| Holland Community Hospital | Holland | Michigan | 49423 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| Mercy Health Partners-Hackley Campus | Muskegon | Michigan | 49442 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| Metro Health Hospital | Wyoming | Michigan | 49519 | United States |
| Singing River Hospital | Pascagoula | Mississippi | 39581 | United States |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | United States |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | United States |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | United States |
| Saint Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| Cooper Hospital University Medical Center | Camden | New Jersey | 08103 | United States |
| Virtua Memorial | Mount Holly | New Jersey | 08060 | United States |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07101 | United States |
| Community Medical Center | Toms River | New Jersey | 08755 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Beth Israel Medical Center | New York | New York | 10003 | United States |
| Saint Luke's Roosevelt Hospital Center - Saint Luke's Division | New York | New York | 10025 | United States |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139 | United States |
| Summa Akron City Hospital/Cooper Cancer Center | Akron | Ohio | 44304 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| UPMC-Heritage Valley Health System Beaver | Beaver | Pennsylvania | 15009 | United States |
| UPMC Cancer Center at Clarion Hospital | Clarion | Pennsylvania | 16214 | United States |
| Northeast Radiation Oncology Center | Dunmore | Pennsylvania | 18512 | United States |
| Pocono Medical Center | East Stroudsburg | Pennsylvania | 18301 | United States |
| UPMC Cancer Centers - Arnold Palmer Pavilion | Greensburg | Pennsylvania | 15601 | United States |
| UPMC-Johnstown/John P. Murtha Regional Cancer Center | Johnstown | Pennsylvania | 15901 | United States |
| UPMC Cancer Center at UPMC McKeesport | McKeesport | Pennsylvania | 15132 | United States |
| Upper Delaware Valley Cancer Center | Milford | Pennsylvania | 18337 | United States |
| UPMC-Coraopolis/Heritage Valley Radiation Oncology | Moon Township | Pennsylvania | 15108 | United States |
| UPMC Cancer Center-Natrona Heights | Natrona Heights | Pennsylvania | 15065 | United States |
| UPMC Jameson | New Castle | Pennsylvania | 16105 | United States |
| Radiation Therapy Oncology Group | Philadelphia | Pennsylvania | 19103 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| UPMC-Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC-Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC-Saint Margaret | Pittsburgh | Pennsylvania | 15215 | United States |
| UPMC-Shadyside Hospital | Pittsburgh | Pennsylvania | 15232 | United States |
| UPMC Jefferson Regional Radiation Oncology | Pittsburgh | Pennsylvania | 15236 | United States |
| UPMC-Passavant Hospital | Pittsburgh | Pennsylvania | 15237 | United States |
| UPMC-Saint Clair Hospital Cancer Center | Pittsburgh | Pennsylvania | 15243 | United States |
| UPMC Cancer Center at UPMC Northwest | Seneca | Pennsylvania | 16346 | United States |
| UPMC Uniontown Hospital Radiation Oncology | Uniontown | Pennsylvania | 15401 | United States |
| UPMC Washington Hospital Radiation Oncology | Washington | Pennsylvania | 15301 | United States |
| AnMed Health Hospital | Anderson | South Carolina | 29621 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Wilford Hall Medical Center | Lackland Air Force Base | Texas | 78236 | United States |
| Wheeling Hospital/Schiffler Cancer Center | Wheeling | West Virginia | 26003 | United States |
| Froedtert and the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Aspirus UW Cancer Center | Wisconsin Rapids | Wisconsin | 54494 | United States |
| Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada |
| London Regional Cancer Program | London | Ontario | N6A 4L6 | Canada |
| University Health Network-Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| McGill University Department of Oncology | Montreal | Quebec | H2W 1S6 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) | BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With a Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year. | Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | Eligible patients who started study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | From start of treatment to one year. |
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| Secondary | Percentage of Patients With Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment After the First Year. | Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | Eligible patients who started study treatment and survived more than one year. | Posted | Number | 95% Confidence Interval | percentage of participants | Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from day 366 to death or study termination whichever occurs first, up to 3.6 years. |
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| Secondary | Patient Tolerability to Each Component (Concurrent and Adjuvant) of the Protocol Treatment Regimen | Evaluated in terms of protocol treatment delivery. For concurrent treatment, measured by the percentage of patients who received 2 or more cycles of cisplatin (CDDP) and bevacizumab (BV) during concurrent treatment with radiation therapy(RT) and who had RT scored by the study chair as no variation or minor variation. For adjuvant treatment, measured by the percentage of patients who received 2 or more cycles of CDDP and 5-FU and BV during the adjuvant treatment phase. Estimated using a binomial distribution along with their associated 95% confidence intervals. | Eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From start of treatment to end of treatment (approximately day 109). |
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| Secondary | Death During or Within 30 Days of Discontinuation of Protocol Treatment. | The percentage of patients dying during protocol treatment or within 30 days after the end of treatment. Estimated using a binomial distribution along with associated 95% confidence interval. | Eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From start of treatment to 30 days after end of treatment (treatment ends approximately day 109). |
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| Secondary | One- and Two-year Distant Metastases-free Rates | Distant metastasis is defined as clear evidence of distant metastases (lung, bone, brain, etc.); biopsy is recommended where possible. Distant metastasis-free rate estimated by cumulative incidence method with death considered a competing risk. | Eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to two years |
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| Secondary | One- and Two-year Loco-regional Progression-free Rates | Loco-regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Local-regional progression-free rate estimated by cumulative incidence with death considered a competing risk. | Eligible patients who started study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years. |
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| Secondary | One- and Two-year Progression-free Survival Rates | Progression-free survival rate estimated by Kaplan-Meier method along with 95% confidence interval. An event is loco-regional or distant progression, or death due to any cause. Loco-regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as distant metastases. | Eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years. |
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| Secondary | One- and Two-year Overall Survival Rates | Overall survival rate estimated by Kaplan-Meier method along with 95% confidence interval. An event is death due to any cause. | Eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years. |
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| Secondary | Percentage of Patients With Other Grade 3-5 Adverse Events Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment | Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | Eligible patients who started treatment | Posted | Number | 95% Confidence Interval | percentage of participants | Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from start of treatment to death or study termination whichever occurs first, up to 3.6 years. |
|
Not provided
Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) | BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Data is reported for eligible patients with adverse event data who started study treatment, which is 44 patients. | 28 | 44 | 44 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Paroxysmal atrial tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rectal fistula | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| General disorders and administration site conditions - Other | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Catheter related infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Infections and infestations - Other | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Penile infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral nerve infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blood antidiuretic hormone abnormal | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Laryngeal mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Paroxysmal atrial tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ear and labyrinth disorders - Other | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| External ear inflammation | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Middle ear inflammation | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Eye disorders - Other | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anal mucositis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Esophageal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lip pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rectal fistula | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rectal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Edema face | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| General disorders and administration site conditions - Other | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gum infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Infections and infestations - Other | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral nerve infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Radiation recall reaction (dermatologic) | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| GGT increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| INR increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Investigations - Other | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Avascular necrosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Non-systematic Assessment |
| |
| Accessory nerve disorder | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Acoustic nerve disorder NOS | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysphasia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Facial muscle weakness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Myelitis | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nervous system disorders - Other | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Psychosis | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urine discoloration | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Irregular menstruation | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Laryngeal edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Laryngeal mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pharyngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pharyngeal stenosis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin atrophy | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphedema | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | Radiation Therapy Oncology Group (RTOG) | wseiferheld@acr.org |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D000068258 | Bevacizumab |
| D007074 | Immunoglobulin G |
| D004220 | Disulfides |
| D002945 | Cisplatin |
| C044245 | 1,2-diaminocyclohexaneplatinum II citrate |
| D010984 | Platinum |
| D005472 | Fluorouracil |
| C029917 | dehydroftorafur |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007132 | Immunoglobulin Isotypes |
| D013440 | Sulfides |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006862 | Hydrogen Sulfide |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D028561 | Transition Elements |
| D008670 | Metals |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
|
|
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| Units | Counts |
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| Participants |
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