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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000472905 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| NRG Oncology | OTHER |
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RATIONALE: Specialized radiation therapy (RT), such as intensity-modulated radiation therapy (IMRT), that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving intensity-modulated radiation therapy to the pelvis with or without chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy to the pelvis with or without chemotherapy works in treating patients with endometrial cancer or cervical cancer that has been removed by surgery.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (cervical vs endometrial cancer).
All patients undergo intensity modulated radiotherapy (IMRT) once a day, 5 days a week, for 5.5 weeks. Patients with cervical cancer also receive cisplatin IV over 30-60 minutes on day 1 or 2. Treatment with cisplatin repeats every 7 days for 5 courses (during radiotherapy) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 6 weeks post-IMRT and then every 3 months for 2 years, every 6 months for years 3-5, and then annually for at least 3 years.
PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endometrial Cancer: IMRT | Other | Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks. |
|
| Cervical Cancer: IMRT + Chemotherapy (cisplatin) | Other | Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks and concurrent weekly cisplatin 40 mg/m^2 for five weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug |
| ||
| intensity-modulated radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review) | Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is <= 80%. The alternative hypothesis is that the true probability is >= 95%. For [vagina / pelvic lymph nodes]: UD is defined as: The 90% isodose surface covers < 95% of [internal target volume (ITV)/ planned target volume (PTV)] 50.4 or > 5% of the [ITV/PTV] 50.4 receives over 115%. | IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Grade 2+ Bowel Adverse Events | Bowel adverse events are defined as any of the following adverse events: diarrhea; enteritis; fistula; ileus:gastrointestinal (GI); incontinence:anal; necrosis:GI; obstruction:GI; perforation:GI; proctitis; stricture/stenosis (including anastomotic):GI. Adverse events are graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (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, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event. |
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DISEASE CHARACTERISTICS:
Must have undergone a hysterectomy (total abdominal, vaginal, radical, or laparoscopic-assisted vaginal) within 7 weeks prior to study entry
Histologically confirmed diagnosis of 1 of the following:
Endometrial cancer meeting 1 of the following criteria:
Stage IB grade 3, IC grade 1-3, IIA, or IIB disease requiring postoperative pelvic radiotherapy
Unstaged (no lymph node dissection or sampling) stage IB grade 2 disease
Stage IIIC with all of the following:
Cervical cancer meeting 1 of the following criteria:
Post-radical hysterectomy and requires postoperative pelvic radiotherapy due to any of the following:
Positive pelvic nodes (negative para-aortic nodes)
Microscopic parametrial involvement and negative margins
Disease qualified by Sedlis criteria must have 2 of the following risk factors:
Post-simple hysterectomy with negative margins and negative nodes by CT scan, MRI, or positron emission tomography-CT scan
No requirement for extended-field radiotherapy beyond the pelvis
No histologically confirmed papillary serous, clear cell, or neuroendocrine (either large or small cell) disease, endometrial stromal sarcoma, leiomyosarcoma, or malignant müllerian mixed tumor
No evidence of metastatic disease outside of the pelvis
No microscopic involvement of the resection margin (< 3 mm)
PATIENT CHARACTERISTICS:
Zubrod performance status 0-2
WBC (white blood cell count) ≥ 4,000/mm³ (cervical cancer patients only)
Absolute neutrophil count ≥ 1,800/mm³ (cervical cancer patients only)
Platelet count ≥ 100,000/mm³ (cervical cancer patients only)
Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
Serum creatinine ≤ 2.0 mg/dL (cervical cancer patients only)
Creatinine clearance ≥ 50 mL/min (cervical cancer patients only)
AST (aspartate aminotransferase) ≤ 2 times upper limit of normal
Bilirubin ≤ 2 times upper limit of normal
Patients must not exceed the weight and size limits of the treatment table or CT scanner
No active inflammatory bowel disease
No severe, active, concurrent illness, defined as any of the following:
No history of allergy to cisplatin (cervical cancer patients)
No prior invasive malignancy (except nonmelanoma skin cancer) unless disease-free for ≥ 3 years
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Anuja Jhingran, MD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auburn Radiation Oncology | Auburn | California | 95603 | United States | ||
| Radiation Oncology Centers - Cameron Park |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22543211 | Result | Jhingran A, Winter K, Portelance L, Miller B, Salehpour M, Gaur R, Souhami L, Small W Jr, Berk L, Gaffney D. A phase II study of intensity modulated radiation therapy to the pelvis for postoperative patients with endometrial carcinoma: radiation therapy oncology group trial 0418. Int J Radiat Oncol Biol Phys. 2012 Sep 1;84(1):e23-8. doi: 10.1016/j.ijrobp.2012.02.044. Epub 2012 Apr 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Endometrial Cancer: IMRT | Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) |
| FG001 | Cervical Cancer: IMRT + Chemotherapy (Cisplatin) | Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Radiation |
|
| From the start of treatment to 90 days. |
| Percentage of Patients With Any Grade 3+ Treatment-related Adverse Events | Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (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, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. | From start of treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients. |
| Percentage of Patients With Any Late Grade 3+ Treatment-related Adverse Events | Adverse events were graded using the Common Terminology Criteria for Adverse Events (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 adverse events (AE) based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Late is defined as more than 90 days after the start of radiation therapy. | From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients. |
| Percentage of Cervical Carcinoma Patients That Were Chemotherapy Compliant | Chemotherapy treatment was centrally reviewed for quality assurance and compliance once complete chemotherapy treatment data was received from sites. | From start to end of chemotherapy, approximately five weeks from registration. |
| Rate of Local-regional Failure at Five Years | Local-regional failure time is defined as time from registration to date of local-regional failure (any failure in the treatment field, which will be the pelvis only), death without local-regional failure (competing risk), or last known follow-up (censored). Local-regional failure rates are estimated by the cumulative incidence method. | From registration to five years. |
| Rate of Distant Metastases at Five Years | Distant Metastases failure time is defined as time from registration to date of distant disease, death without distant metastases (competing risk), or last known follow-up (censored) and is estimated by the cumulative incidence method. Para-aortic nodal disease is considered to be distant disease for a cervical primary, but not for an endometrial primary. | From registration to five years |
| Rate of Disease-free Survival at Five Years | Disease-free survival time is defined as time from registration to date of failure (any tumor recurrence, development of distant metastases or death from any cause) and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact. | From registration five years |
| Rate of Overall Survival at Five Years | Overall survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. | From randomization to five years |
| Cameron Park |
| California |
| 95682 |
| United States |
| Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael | California | 95608 | United States |
| East Bay Radiation Oncology Center | Castro Valley | California | 94546 | United States |
| Eden 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 | 91010-3000 | United States |
| Valley Medical Oncology | Fremont | California | 94538 | United States |
| Rebecca and John Moores UCSD Cancer Center | La Jolla | California | 92093-0658 | United States |
| Highland General Hospital | Oakland | California | 94602 | United States |
| Alta Bates Summit Medical Center - Summit Campus | Oakland | California | 94609 | United States |
| Bay Area Breast Surgeons, Incorporated | Oakland | California | 94609 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609 | United States |
| Larry G Strieff MD Medical Corporation | Oakland | California | 94609 | United States |
| Tom K Lee, Incorporated | Oakland | California | 94609 | United States |
| Valley Care Medical Center | Pleasanton | California | 94588 | United States |
| Valley Medical Oncology Consultants - Pleasanton | Pleasanton | California | 94588 | United States |
| Radiation Oncology Center - Roseville | Roseville | California | 95661 | United States |
| Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento | California | 95815 | United States |
| Mercy General Hospital | Sacramento | California | 95819 | United States |
| Veterans Affairs Medical Center - San Diego | San Diego | California | 92161 | United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| Doctors Medical Center - San Pablo Campus | San Pablo | California | 94806 | United States |
| Solano Radiation Oncology Center | Vacaville | California | 95687 | United States |
| Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | 19958 | United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | United States |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | United States |
| Bay Medical | Panama City | Florida | 32401 | United States |
| St. Joseph Medical Center | Bloomington | Illinois | 61701 | United States |
| Graham Hospital | Canton | Illinois | 61520 | United States |
| Memorial Hospital | Carthage | Illinois | 62321 | United States |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States |
| Alexian Brothers Radiation Oncology | Elk Grove Village | Illinois | 60007 | United States |
| Eureka Community Hospital | Eureka | Illinois | 61530 | United States |
| Galesburg Clinic, PC | Galesburg | Illinois | 61401 | United States |
| Galesburg Cottage Hospital | Galesburg | Illinois | 61401 | United States |
| InterCommunity Cancer Center of Western Illinois | Galesburg | Illinois | 61401 | United States |
| Mason District Hospital | Havana | Illinois | 62644 | United States |
| Hopedale Medical Complex | Hopedale | Illinois | 61747 | United States |
| McDonough District Hospital | Macomb | Illinois | 61455 | United States |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| BroMenn Regional Medical Center | Normal | Illinois | 61761 | United States |
| Community Cancer Center | Normal | Illinois | 61761 | United States |
| Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields | Olympia Fields | Illinois | 60461 | United States |
| Community Hospital of Ottawa | Ottawa | Illinois | 61350 | United States |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois | 61350 | United States |
| Cancer Treatment Center at Pekin Hospital | Pekin | Illinois | 61554 | United States |
| Proctor Hospital | Peoria | Illinois | 61614 | United States |
| OSF St. Francis Medical Center | Peoria | Illinois | 61615-7827 | United States |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61615 | United States |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois | 61615 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| Illinois Valley Community Hospital | Peru | Illinois | 61354 | United States |
| Perry Memorial Hospital | Princeton | Illinois | 61356 | United States |
| St. Margaret's Hospital | Spring Valley | Illinois | 61362 | United States |
| Valley Cancer Center | Spring Valley | Illinois | 61362 | United States |
| Cancer Institute at St. John's Hospital | Springfield | Illinois | 62702 | United States |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | 46107 | United States |
| Oncology Center at Saint Margaret Mercy Healthcare Center | Hammond | Indiana | 46320 | United States |
| Reid Hospital & Health Care Services | Richmond | Indiana | 47374 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1002 | United States |
| Providence Medical Center | Kansas City | Kansas | 66112 | United States |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | United States |
| Menorah Medical Center | Overland Park | Kansas | 66209 | United States |
| Johnson County Radiation Therapy | Overland Park | Kansas | 66210 | United States |
| Shawnee Mission Medical Center | Shawnee Mission | Kansas | 66204 | United States |
| Central Maine Comprehensive Cancer Center at Central Maine Medical Center | Lewiston | Maine | 04240 | United States |
| Union Hospital Cancer Program at Union Hospital | Elkton | Maryland | 21921 | United States |
| Dana-Farber/Brigham and Women's Cancer Center | Boston | Massachusetts | 02115 | United States |
| South Suburban Oncology Center | Quincy | Massachusetts | 02169 | United States |
| South Shore Hospital | South Weymouth | Massachusetts | 02190 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0942 | United States |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Cancer Institute of Cape Girardeau, LLC | Cape Girardeau | Missouri | 63703 | United States |
| Independence Regional Health Center | Independence | Missouri | 64050 | United States |
| Truman Medical Center - Hospital Hill | Kansas City | Missouri | 64108 | United States |
| Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Kansas City Cancer Center at St. Joseph's Medical Mall | Kansas City | Missouri | 64114 | United States |
| St. Joseph Medical Center | Kansas City | Missouri | 64114 | United States |
| North Kansas City Hospital | Kansas City | Missouri | 64116 | United States |
| Parvin Radiation Oncology | Kansas City | Missouri | 64116 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| Research Medical Center | Kansas City | Missouri | 64132 | United States |
| Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center | Kansas City | Missouri | 64154 | United States |
| Heartland Regional Medical Center | Saint Joseph | Missouri | 64506 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65802 | United States |
| St. John's Regional Health Center | Springfield | Missouri | 65804 | United States |
| Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri | 65807 | United States |
| Cancer Institute of New Jersey at Cooper University Hospital - Camden | Camden | New Jersey | 08103 | United States |
| Monmouth Medical Center | Long Branch | New Jersey | 07740-6395 | United States |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08903 | United States |
| Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare | Vineland | New Jersey | 08360 | United States |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| Lovelace Medical Center - Downtown | Albuquerque | New Mexico | 87102 | United States |
| Radiation Oncology Associates, PA | Albuquerque | New Mexico | 87109 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87131-5636 | United States |
| Cancer Institute of New Mexico | Santa Fe | New Mexico | 87505 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| Beth Israel Medical Center - Petrie Division | New York | New York | 10003-3803 | United States |
| St. Luke's - Roosevelt Hospital Center - St.Luke's Division | New York | New York | 10025 | United States |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | 28233-3549 | United States |
| McDowell Cancer Center at Akron General Medical Center | Akron | Ohio | 44307 | United States |
| Summa Center for Cancer Care at Akron City Hospital | Akron | Ohio | 44309-2090 | United States |
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| Huron Hospital Cancer Care Center | Cleveland | Ohio | 44112 | United States |
| Euclid Hospital | Cleveland | Ohio | 44119 | United States |
| Grandview Hospital | Dayton | Ohio | 45405 | United States |
| Good Samaritan Hospital | Dayton | Ohio | 45406 | United States |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Samaritan North Cancer Care Center | Dayton | Ohio | 45415 | United States |
| Veterans Affairs Medical Center - Dayton | Dayton | Ohio | 45428 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| Blanchard Valley Medical Associates | Findlay | Ohio | 45840 | United States |
| Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | United States |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | United States |
| Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights | Ohio | 44124 | United States |
| Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem | Ohio | 44460 | United States |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373-1300 | United States |
| South Pointe Hospital Cancer Care Center | Warrensville Heights | Ohio | 44122 | United States |
| Clinton Memorial Hospital | Wilmington | Ohio | 45177 | United States |
| Cancer Treatment Center | Wooster | Ohio | 44691 | United States |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill | Pennsylvania | 19026 | United States |
| Cancer Center of Paoli Memorial Hospital | Paoli | Pennsylvania | 19301-1792 | United States |
| CCOP - Main Line Health | Wynnewood | Pennsylvania | 19096 | United States |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport | Tennessee | 37662 | United States |
| M. D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| American Fork Hospital | American Fork | Utah | 84003 | United States |
| Sandra L. Maxwell Cancer Center | Cedar City | Utah | 84720 | United States |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray | Utah | 84157 | United States |
| Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84604 | United States |
| LDS Hospital | Salt Lake City | Utah | 84103 | United States |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah | 84106 | United States |
| Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah | 84112 | United States |
| Dixie Regional Medical Center - East Campus | St. George | Utah | 84770 | United States |
| Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | 05401 | United States |
| Southwest Virginia Regional Cancer Center at Wellmonth Health | Norton | Virginia | 24273 | United States |
| CCOP - Virginia Mason Research Center | Seattle | Washington | 98101 | United States |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792-6164 | United States |
| Columbia Saint Mary's Hospital - Ozaukee | Mequon | Wisconsin | 53097 | United States |
| Columbia-Saint Mary's Cancer Care Center | Milwaukee | Wisconsin | 53211 | United States |
| University of Wisconcin Cancer Center at Aspirus Wausau Hospital | Wausau | Wisconsin | 54401 | United States |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| McGill Cancer Centre at McGill University | Montreal | Quebec | H2W 1S6 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All registered patients.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Endometrial Cancer: IMRT | Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) |
| BG001 | Cervical Cancer: IMRT + Chemotherapy (Cisplatin) | Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin) |
| BG002 | Total | Total of all reporting groups |
| 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 | Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review) | Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is <= 80%. The alternative hypothesis is that the true probability is >= 95%. For [vagina / pelvic lymph nodes]: UD is defined as: The 90% isodose surface covers < 95% of [internal target volume (ITV)/ planned target volume (PTV)] 50.4 or > 5% of the [ITV/PTV] 50.4 receives over 115%. | All eligible patients. | Posted | Number | participants | IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery. |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Grade 2+ Bowel Adverse Events | Bowel adverse events are defined as any of the following adverse events: diarrhea; enteritis; fistula; ileus:gastrointestinal (GI); incontinence:anal; necrosis:GI; obstruction:GI; perforation:GI; proctitis; stricture/stenosis (including anastomotic):GI. Adverse events are graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (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, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event. | Eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From the start of treatment to 90 days. |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Any Grade 3+ Treatment-related Adverse Events | Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (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, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, 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 the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients. |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Any Late Grade 3+ Treatment-related Adverse Events | Adverse events were graded using the Common Terminology Criteria for Adverse Events (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 adverse events (AE) based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Late is defined as more than 90 days after the start of radiation therapy. | Eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients. |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Cervical Carcinoma Patients That Were Chemotherapy Compliant | Chemotherapy treatment was centrally reviewed for quality assurance and compliance once complete chemotherapy treatment data was received from sites. | Eligible patients in the chemotherapy group (cervical cancer patients) who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From start to end of chemotherapy, approximately five weeks from registration. |
|
| |||||||||||||||||||||||||||||
| Secondary | Rate of Local-regional Failure at Five Years | Local-regional failure time is defined as time from registration to date of local-regional failure (any failure in the treatment field, which will be the pelvis only), death without local-regional failure (competing risk), or last known follow-up (censored). Local-regional failure rates are estimated by the cumulative incidence method. | Eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to five years. |
|
| |||||||||||||||||||||||||||||
| Secondary | Rate of Distant Metastases at Five Years | Distant Metastases failure time is defined as time from registration to date of distant disease, death without distant metastases (competing risk), or last known follow-up (censored) and is estimated by the cumulative incidence method. Para-aortic nodal disease is considered to be distant disease for a cervical primary, but not for an endometrial primary. | Eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to five years |
|
| |||||||||||||||||||||||||||||
| Secondary | Rate of Disease-free Survival at Five Years | Disease-free survival time is defined as time from registration to date of failure (any tumor recurrence, development of distant metastases or death from any cause) and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact. | Eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From registration five years |
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| Secondary | Rate of Overall Survival at Five Years | Overall survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. | Eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to five years |
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Not provided
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
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 | Endometrial Cancer: IMRT | Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) | 2 | 43 | 42 | 43 | ||
| EG001 | Cervical Cancer: IMRT + Chemotherapy (Cisplatin) | Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin) | 3 | 40 | 39 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Vomiting NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Urinary tract infection NOS | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
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| Lymphopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
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| Neutrophil count | Investigations | CTCAE (3.0) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Hearing impaired | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal distention | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Abdominal pain NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Anal discomfort | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Diarrhoea NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Enteritis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Gastritis NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Proctitis NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Vomiting NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pain NOS | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Gingival infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
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| Urinary tract infection NOS | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
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| Dermatitis radiation NOS | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
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| Fracture NOS | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
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| Radiation recall syndrome | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
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| Blood bilirubin increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
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| Blood creatinine increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
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| Leukopenia NOS | Investigations | CTCAE (3.0) | Non-systematic Assessment |
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| Lymphopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
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| Neutrophil count | Investigations | CTCAE (3.0) | Non-systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
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| Weight decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperglycaemia NOS | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Buttock pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Libido decreased | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Bladder spasm | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Cystitis NOS | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Urethral pain | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pelvic pain NOS | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Vaginal atresia | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Vaginal discharge | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Vaginal hemorrhage | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Vaginal pain | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Vaginal stricture | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Vaginitis | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Vulvovaginal dryness | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Telangiectasia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Hot flushes NOS | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | Radiation Therapy Oncology Group (RTOG) | wseiferheld@acr.org |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
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