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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000271939 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin and etoposide together with radiation therapy works in treating patients with limited-stage small cell lung cancer.
OBJECTIVES:
OUTLINE: Patients undergo radiotherapy once daily 5 days a week for approximately 3 weeks and then twice daily 5 days a week for approximately 2 weeks (a total of 9 treatment days during the final 2-week treatment period). Beginning on the first day of radiotherapy, patients receive cisplatin IV over 2 hours and etoposide IV over 1 hour on day 1 and oral etoposide once daily on days 2 and 3. Chemotherapy repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Therapy + Chemotherapy | Experimental | Accelerated high dose thoracic radiation therapy (RT) with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | 60 mg/m2 given intravenously. During RT, give on day 1 and day 22. After completion of RT, on days 43 and 64. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival at 2 Years | Survival time is defined as time from study registration to the date of death from any cause and survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. | From registration to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) and Progression-free Survival (PFS) at 1 Year | An event for overall survival is death due to any cause. Overall survival time is defined as time from study registration to the date of death from any cause. An event for progression-free survival is the first of the following: local progression, regional progression, distant metastases, or death due to any cause. Progression-free survival time is defined as time from study registration to the date of first failure. For both outcome measures, patients last known to be alive without failure are censored at the date of last contact. Survival rates are estimated by the Kaplan-Meier method. |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell carcinoma of the lung by fine needle aspiration biopsy or two positive sputa
Must have limited disease
Stage I, II, IIIA, or IIIB
Confined to 1 hemithorax, but excluding the following:
No pericardial or pleural effusions on chest x-ray (regardless of cytology)
Measurable or evaluable disease
Tumor must be able to be encompassed by limited radiotherapy fields without significantly compromising pulmonary function
No prior complete tumor resection
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Ritsuko U. Komaki, MD, FACR | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22560543 | Result | Komaki R, Paulus R, Ettinger DS, Videtic GM, Bradley JD, Glisson BS, Langer CJ, Sause WT, Curran WJ Jr, Choy H. Phase II study of accelerated high-dose radiotherapy with concurrent chemotherapy for patients with limited small-cell lung cancer: Radiation Therapy Oncology Group protocol 0239. Int J Radiat Oncol Biol Phys. 2012 Jul 15;83(4):e531-6. doi: 10.1016/j.ijrobp.2012.01.075. Epub 2012 May 5. | |
| Result | Komaki R, Paulus R, Ettinger DS, et al.: A phase II study of accelerated high-dose thoracic radiation therapy (AHTRT) with concurrent chemotherapy for limited small cell lung cancer: RTOG 0239. [Abstract] J Clin Oncol 27 (Suppl 15): A-7527, 2009. | ||
| Result | Komaki R, Moughan J, Ettinger D, et al.: Toxicities in a phase II study of accelerated high dose thoracic radiation therapy (TRT) with concurrent chemotherapy for limited small cell lung cancer (LSCLC) (RTOG 0239). [Abstract] J Clin Oncol 25 (Suppl 18): A-7717, 438s, 2007. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiation Therapy + Chemotherapy | Accelerated high dose thoracic radiation therapy (RT) with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Etoposide | Drug | 120 mg/m2 given intravenously. During RT, give on days 1-3, then days 22-24. After completion of RT, on days 43-45 and days 64-66. |
|
| Radiation therapy | Radiation | Large field 28.8 Gy: 1.8 Gy per fraction, 5 days per week for 16 fractions. On days 23-26, BID: use anteroposterior and posteroanterior (AP/PA) fields in a.m. at 1.8 Gy per fraction; boost with 2nd treatment in p.m. at 1.8 Gy per fraction. Then off-cord boost, 1.8 Gy, BID, x last 5 days for a total dose of 61.2 Gy in 5 wks. |
|
| From registration to one year. |
| Median Overall Survival Time and Progression-free Survival Time | An event for overall survival is death due to any cause. Overall survival time is defined as time from study registration to the date of death from any cause. An event for progression-free survival is the first of the following: local progression, regional progression, distant metastases, or death due to any cause. Progression-free survival time is defined as time from study registration to the date of first failure. For both outcome measures, patients last known to be alive without failure are censored at the date of last contact. Survival rates are estimated by the Kaplan-Meier method. | From registration to 2 years |
| Number of Patients With Acute Treatment-related Grade 3 or 4 Esophagitis | Highest grade treatment-related toxicity per subject was counted. Toxicities were graded using Common Toxicity Criteria (CTC) v 2.0. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity 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 toxicity. | From start of radiation therapy until 90 days following the start of radiation therapy |
| Frequency of Treatment-related Fatalities at 2 Years | A treatment-related fatality was any death judged to be related to protocol treatment. | From the start of treatment to 2 years |
| Tumor Response | Response will be recorded as the best response observed two months after the completion of chemoradiation therapy. Tumor response as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions as measured by MRI, CT, or physical examination (this is the order of preference for measurement). Partial Response (PR): >= 30% decrease in the sum of the longest diameter (LD) of target lesions (order of preference for measurement is MRI, CT, physical examination). Progressive Disease (PD): >= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions (order of preference for measurement is MRI, CT, physical examination). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. | From the start of treatment to 2 months following the completion of chemotherapy |
| Eden Medical Center |
| Castro Valley |
| California |
| 94546 |
| United States |
| Saint Rose Hospital | Hayward | California | 94545 | United States |
| Highland General Hospital at St. George's University School of Medicine | Oakland | California | 94602 | United States |
| Alta Bates Summit Medical Center - Summit Campus | Oakland | California | 94609 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609 | United States |
| Valley Care Medical Center | Pleasanton | California | 94588 | United States |
| Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center | Pomona | California | 91767 | United States |
| J.C. Robinson, M.D. Regional Cancer Center | San Pablo | California | 94806 | United States |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia | 31403-3089 | 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 |
| Eureka Community Hospital | Eureka | Illinois | 61530 | United States |
| Galesburg Clinic | Galesburg | Illinois | 61401 | United States |
| Galesburg Cottage Hospital | Galesburg | Illinois | 61401 | United States |
| Mason District Hospital | Havana | Illinois | 62644 | United States |
| Kewanee Hospital | Kewanee | Illinois | 61443 | United States |
| McDonough District Hospital | Macomb | Illinois | 61455 | United States |
| BroMenn Regional Medical Center | Normal | Illinois | 61761 | United States |
| Community Cancer Center | Normal | Illinois | 61761 | 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 |
| 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 |
| 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 |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | 46107 | United States |
| Elkhart General Hospital | Elkhart | Indiana | 46515 | United States |
| Howard Community Hospital at Howard Regional Health System | Kokomo | Indiana | 46904 | United States |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | 46350 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| Saint Joseph Regional Medical Center | South Bend | Indiana | 46617 | United States |
| Wendt Regional Cancer Center at Finley Hospital | Dubuque | Iowa | 52001 | United States |
| Cancer Treatment Center at the Medical Center - Bowling Green | Bowling Green | Kentucky | 42101 | United States |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536-0293 | United States |
| St. Agnes Cancer Center | Baltimore | Maryland | 21229 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
| St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor | Michigan | 48106-0995 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan | 48123-2500 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| Foote Hospital | Jackson | Michigan | 49201 | 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 |
| Sparrow Regional Cancer Center | Lansing | Michigan | 48909 | United States |
| Seton Cancer Institute - Saginaw | Saginaw | Michigan | 48601 | United States |
| Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph | Michigan | 49085 | United States |
| St. John Macomb Hospital | Warren | Michigan | 48093 | United States |
| Saint Louis University Cancer Center | St Louis | Missouri | 63110 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| J. Phillip Citta Regional Cancer Center at Community Medical Center | Toms River | New Jersey | 08755 | United States |
| Fox Chase Cancer Center at St. Francis Medical Center | Trenton | New Jersey | 08629 | United States |
| South Jersey Healthcare Regional Cancer Center | Vineland | New Jersey | 08360 | United States |
| Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center | Plattsburgh | New York | 12901 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Wayne Radiation Oncology | Goldsboro | North Carolina | 27534 | United States |
| Wilmed Radiation Oncology Services | Wilson | North Carolina | 27893 | United States |
| Akron City Hospital | Akron | Ohio | 44309-2090 | United States |
| Aultman Hospital Cancer Center at Aultman Health Foundation | Canton | Ohio | 44710-1799 | United States |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | 45267 | United States |
| Huron Hospital Cancer Care Center | Cleveland | Ohio | 44112 | United States |
| Euclid Hospital | Cleveland | Ohio | 44119 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | 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 |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | United States |
| Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights | Ohio | 44124 | United States |
| Middletown Regional Hospital | Middletown | Ohio | 45044 | 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 |
| 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 |
| Paoli Memorial Hospital | Paoli | Pennsylvania | 19301-1792 | United States |
| Reading Hospital and Medical Center | Reading | Pennsylvania | 19612-6052 | United States |
| CCOP - MainLine 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 |
| M.D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| Cottonwood Hospital Medical Center | Murray | Utah | 84107 | United States |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84604 | United States |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah | 84106 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Regional Medical Center - East Campus | St. George | Utah | 84770 | United States |
| Schiffler Cancer Center at Wheeling Hospital | Wheeling | West Virginia | 26003 | United States |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| Columbia St. Mary's Cancer Care Center | Milwaukee | Wisconsin | 53211 | United States |
| Veterans Affairs Medical Center - Milwaukee | Milwaukee | Wisconsin | 53295 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Eligible patients who started protocol treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiation Therapy + Chemotherapy | Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy |
| 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 | Overall Survival at 2 Years | Survival time is defined as time from study registration to the date of death from any cause and survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. | All eligible patients who started study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to 2 years |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) and Progression-free Survival (PFS) at 1 Year | An event for overall survival is death due to any cause. Overall survival time is defined as time from study registration to the date of death from any cause. An event for progression-free survival is the first of the following: local progression, regional progression, distant metastases, or death due to any cause. Progression-free survival time is defined as time from study registration to the date of first failure. For both outcome measures, patients last known to be alive without failure are censored at the date of last contact. Survival rates are estimated by the Kaplan-Meier method. | Eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to one year. |
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| Secondary | Median Overall Survival Time and Progression-free Survival Time | An event for overall survival is death due to any cause. Overall survival time is defined as time from study registration to the date of death from any cause. An event for progression-free survival is the first of the following: local progression, regional progression, distant metastases, or death due to any cause. Progression-free survival time is defined as time from study registration to the date of first failure. For both outcome measures, patients last known to be alive without failure are censored at the date of last contact. Survival rates are estimated by the Kaplan-Meier method. | All eligible patients who started study treatment | Posted | Median | 95% Confidence Interval | months | From registration to 2 years |
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| Secondary | Number of Patients With Acute Treatment-related Grade 3 or 4 Esophagitis | Highest grade treatment-related toxicity per subject was counted. Toxicities were graded using Common Toxicity Criteria (CTC) v 2.0. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity 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 toxicity. | Eligible patients who started study treatment | Posted | Count of Participants | Participants | From start of radiation therapy until 90 days following the start of radiation therapy |
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| Secondary | Frequency of Treatment-related Fatalities at 2 Years | A treatment-related fatality was any death judged to be related to protocol treatment. | Eligible patients who started study treatment | Posted | Count of Participants | Participants | From the start of treatment to 2 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tumor Response | Response will be recorded as the best response observed two months after the completion of chemoradiation therapy. Tumor response as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions as measured by MRI, CT, or physical examination (this is the order of preference for measurement). Partial Response (PR): >= 30% decrease in the sum of the longest diameter (LD) of target lesions (order of preference for measurement is MRI, CT, physical examination). Progressive Disease (PD): >= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions (order of preference for measurement is MRI, CT, physical examination). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. | Eligible patients who started study treatment and were observed for at least 2 months post-treatment | Posted | Count of Participants | Participants | From the start of treatment to 2 months following the completion of chemotherapy |
|
|
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Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiation Therapy + Chemotherapy | Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy | 67 | 71 | 71 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hematologic-Other | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hemoglobin (Hgb) | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hemoglobin (Hgb) for leukemia | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis, other) | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Thrombotic microangiopathy for BMT (e.g., thrombotic thrombocytopenic purpura/TTP or hemolytic urem | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Transfusion: Platelets | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Transfusion: pRBCs | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Arrhythmia- other | Cardiac disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Circulatory or cardiac-Other | Cardiac disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Heart: NOS | Cardiac disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Pericardial effusion/pericarditis | Cardiac disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Diarrhea (without colostomy) | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dysphagia, esophagitis, odynophagia (painful swallowing) | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dysphagia-esophageal related to radiation | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| GI-Other | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Mucositis due to radiation | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Fatigue (lethargy, malaise, asthenia) | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 109/L) | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pain-Other | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hepatic-Other | Hepatobiliary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Infection with grade 3 or 4 neutropenia | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Infection with unknown ANC | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Infection without neutropenia | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Infection, Other | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Wound-infectious | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Operative injury of vein/artery | Injury, poisoning and procedural complications | CTC (2.0) | Non-systematic Assessment |
| |
| Bilirubin | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Cardiac troponin T (cTnT) | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Creatinine | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Leukocytes (total WBC) | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Platelets | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| SIADH (syndrome of inappropriate anti-diuretic hormone) | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypomagnesmia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| CNS cerebrovascular ischemia | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Memory loss | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralgia, or | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Neuropathy motor | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Neuropathy-sensory | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Seizure(s) | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Apnea | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Lung: NOS | Respiratory, thoracic and mediastinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pulmonary-Other | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia | Vascular disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Peripheral arterial ischemia | Vascular disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Thrombosis/embolism | Vascular disorders | CTC (2.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematologic-Other | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hemoglobin (Hgb) | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Edema | Cardiac disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Diarrhea (without colostomy) | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dyspepsia/heartburn | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dysphagia, esophagitis, odynophagia (painful swallowing) | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dysphagia-esophageal related to radiation | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dysphagia-pharyngeal related to radiation | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| GI-Other | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Esophagus: NOS | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Chest pain (non-cardiac and non-pleuritic) | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Fatigue (lethargy, malaise, asthenia) | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 109/L) | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Other: NOS | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Pain due to radiation | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pain-Other | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Skin: NOS | Injury, poisoning and procedural complications | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Radiation dermatitis | Injury, poisoning and procedural complications | CTC (2.0) | Non-systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Creatinine | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Leukocytes (total WBC) | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Platelets | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypomagnesmia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Muscle weakness (not due to neuropathy) | Musculoskeletal and connective tissue disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Myalgia (muscle ache) | Musculoskeletal and connective tissue disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Ataxia (incoordination) | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dizziness/lightheadedness | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Memory loss | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Neuropathy motor | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Neuropathy-sensory | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Taste disturbance (dysgeusia) | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Mood alteration-depression | Psychiatric disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Lung: NOS | Respiratory, thoracic and mediastinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTC (2.0) | Non-systematic Assessment |
|
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | NRG Oncology | seiferheldw@nrgoncology.org |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D005047 | Etoposide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013812 | Therapeutics |
Not provided
Not provided
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
| Counts |
|---|
| Participants |
|
|