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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000067250 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy plus radiation therapy is more effective with or without combination chemotherapy for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy plus radiation therapy with or without combination chemotherapy in treating patients who have prostate cancer.
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to prostate-specific antigen level (≤ 10 ng/mL vs 11-100 ng/mL), tumor stage (T1-2 vs T3-4), Gleason score (7 vs 8-10), and prior hormone use (yes vs no). Patients are randomized to one of two treatment arms.
All patients receive androgen suppression comprising a luteinizing hormone-releasing hormone (LHRH) agonist AND bicalutamide OR flutamide for 4 months. Beginning 8 weeks after the initiation of androgen suppression, all patients undergo radiotherapy once daily, 5 days a week, for 7-8 weeks. Patients who received prior androgen suppression therapy count time to radiotherapy from start date of prior hormonal therapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,440 patients will be accrued for this study within 6 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hormones and RT | Experimental | Androgen suppression (AS) (Luteinizing hormone releasing hormone agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT). |
|
| Hormones and RT plus Chemotherapy | Experimental | AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bicalutamide | Drug | Administered orally at a dose of one 50mg tablet per day. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (5-year Rate Reported) | Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 5 years. | From the date of randomization to the date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Biochemical Failure at 5 Years | Biochemical failure uses the American Society for Radiation Oncology (ASTRO) definition of prostate-specific antigen (PSA) rises on three consecutive occasions, with biochemical failure date being midway between the last non-rising PSA and the first rise in PSA. Time to biochemical failure is defined as time from randomization to biochemical failure, last known follow-up (censored), or death (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. |
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DISEASE CHARACTERISTICS:
Histologically proven prostate cancer at high risk for relapse as determined by either of the following:
Negative lymph nodes
No metastatic disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Howard M. Sandler, MD | University of Michigan Rogel Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama | 35294-3300 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18990504 | Result | Rosenthal SA, Bae K, Pienta KJ, Sobczak ML, Asbell SO, Rajan R, Kerlin KJ, Michalski JM, Sandler HM; Radiation Therapy Oncology Group Trial 9902. Phase III multi-institutional trial of adjuvant chemotherapy with paclitaxel, estramustine, and oral etoposide combined with long-term androgen suppression therapy and radiotherapy versus long-term androgen suppression plus radiotherapy alone for high-risk prostate cancer: preliminary toxicity analysis of RTOG 99-02. Int J Radiat Oncol Biol Phys. 2009 Mar 1;73(3):672-8. doi: 10.1016/j.ijrobp.2008.05.020. Epub 2008 Nov 5. | |
| 26209502 |
| Label | URL |
|---|---|
| Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hormones and RT | Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| estramustine phosphate sodium | Drug | 280 mg three times a day for 14 days and repeated every 3 weeks for 4 cycles |
|
| etoposide | Drug | 50 mg/m^2 in divided doses b.i.d. for 14 days and repeated every 3 weeks for 4 cycles |
|
| flutamide | Drug | Administered orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy. |
|
|
| paclitaxel | Drug | 135 mg/m^2 given as a 1-hour infusion (on day 2 of each cycle) and repeated every 3 weeks for 4 cycles |
|
| Luteinizing hormone releasing hormone [LHRH] agonist | Drug | Releasing hormone agonists (such as leuprolide, goserelin, buserelin, triptorelin) will be given for 4 months |
|
| Radiation therapy | Radiation | Radiation will begin 8 weeks following the initiation of hormone administration: 46.8 Gy to the regional lymphatics followed by a 23.4 Gy boost to the prostate to bring the total dose to the prostate to 70.2 Gy. Daily tumor doses will be 1.8 Gy per day, 5 days per week x 7-8 weeks. |
|
| warfarin | Drug | To keep international normalized ratio (INR) > 1.5 and < 2.5; begins with the start of chemotherapy and will be given continuously until 4 weeks after the end of the fourth cycle of chemotherapy |
|
|
| From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years. |
| Rate of Local Progression at 5 Years | Local progression is defined as documented clinical local and/or regional progression. Time to local progression is defined as time from randomization to local progression, last known follow-up (censored), or death (competing risk). Local progression rates are estimated using the cumulative incidence method. | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years. |
| Rate of Distant Metastasis at Five Years | Distant metastasis (DM) is defined as documented metastatic disease. Time to distant metastasis is defined as time from randomization to distant metastatic disease, last known follow-up (censored), or death (competing risk). Distant metastasis rates are estimated using the cumulative incidence method. | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years. |
| Disease-free Survival Rate at 5 Years | Disease-free survival (DFS) was measured from the date of randomization to the date of documentation of progression (local, distant, biochemical failure), death, or last follow-up (censored). The Kaplan-Meier method was used to estimate DFS rates. | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years. |
| Foundation for Cancer Research and Education |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Mount Diablo Medical Center | Concord | California | 94524-4110 | United States |
| Sutter Health Western Division Cancer Research Group | Greenbrae | California | 94904 | United States |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California | 95403 | United States |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver | Colorado | 80010 | United States |
| Baptist Hospital of Miami | Miami | Florida | 33176-2197 | United States |
| Lutheran General Cancer Care Center | Park Ridge | Illinois | 60068 | United States |
| Methodist Cancer Center at Methodist Hospital | Indianapolis | Indiana | 46206-1367 | United States |
| Ball Memorial Hospital Cancer Center | Muncie | Indiana | 47303-3499 | United States |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536-0293 | United States |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | 70809 | United States |
| CCOP - Ochsner | New Orleans | Louisiana | 70121 | United States |
| Anne Arundel Oncology Center | Annapolis | Maryland | 21401 | United States |
| Greater Baltimore Medical Center and Cancer Center | Baltimore | Maryland | 21204 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0010 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| Marquette General Hospital | Marquette | Michigan | 49855 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | 65203 | United States |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Veterans Affairs Medical Center - East Orange | East Orange | New Jersey | 07019 | United States |
| Monmouth Medical Center | Long Branch | New Jersey | 07740-6395 | United States |
| South Jersey Regional Cancer Center | Millville | New Jersey | 08332 | United States |
| Atlantic City Medical Center | Pomona | New Jersey | 08240 | United States |
| Fox Chase Cancer Center at St. Francis Medical Center | Trenton | New Jersey | 08629 | United States |
| CCOP - North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York | 10032 | United States |
| Akron General Medical Center | Akron | Ohio | 44302 | United States |
| Akron City Hospital | Akron | Ohio | 44304 | United States |
| CCOP - Columbus | Columbus | Ohio | 43206 | United States |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio | 43210-1240 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43623-3456 | United States |
| John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital | Allentown | Pennsylvania | 18105 | United States |
| St. Luke's Hospital Cancer Center | Bethlehem | Pennsylvania | 18015 | United States |
| Delaware County Memorial Hospital | Drexel Hill | Pennsylvania | 19026 | United States |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107-5541 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Albert Einstein Cancer Center | Philadelphia | Pennsylvania | 19141-3098 | United States |
| CCOP - MainLine Health | Wynnewood | Pennsylvania | 19096 | United States |
| Wellspan Health - York Cancer Center | York | Pennsylvania | 17403 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Regional Medical Center | St. George | Utah | 84770 | United States |
| University Cancer Center at University of Washington Medical Center | Seattle | Washington | 98195-6043 | United States |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay | Wisconsin | 54301 | United States |
| St. Vincent Hospital | Green Bay | Wisconsin | 54307-3508 | United States |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| All Saints Cancer Center at All Saints Healthcare | Racine | Wisconsin | 53405 | United States |
| Saint John Regional Hospital | Saint John | New Brunswick | E2L 4L2 | Canada |
| Cancer Care Ontario-London Regional Cancer Centre | London | Ontario | N6A 4L6 | Canada |
| Result |
| Rosenthal SA, Hunt D, Sartor AO, Pienta KJ, Gomella L, Grignon D, Rajan R, Kerlin KJ, Jones CU, Dobelbower M, Shipley WU, Zeitzer K, Hamstra DA, Donavanik V, Rotman M, Hartford AC, Michalski J, Seider M, Kim H, Kuban DA, Moughan J, Sandler H. A Phase 3 Trial of 2 Years of Androgen Suppression and Radiation Therapy With or Without Adjuvant Chemotherapy for High-Risk Prostate Cancer: Final Results of Radiation Therapy Oncology Group Phase 3 Randomized Trial NRG Oncology RTOG 9902. Int J Radiat Oncol Biol Phys. 2015 Oct 1;93(2):294-302. doi: 10.1016/j.ijrobp.2015.05.024. Epub 2015 Jul 21. |
| 36596347 | Derived | Nguyen PL, Huang HR, Spratt DE, Davicioni E, Sandler HM, Shipley WU, Efstathiou JA, Simko JP, Pollack A, Dicker AP, Roach M, Rosenthal SA, Zeitzer KL, Mendez LC, Hartford AC, Hall WA, Desai AB, Rabinovitch RA, Peters CA, Rodgers JP, Tran P, Feng FY. Analysis of a Biopsy-Based Genomic Classifier in High-Risk Prostate Cancer: Meta-Analysis of the NRG Oncology/Radiation Therapy Oncology Group 9202, 9413, and 9902 Phase 3 Randomized Trials. Int J Radiat Oncol Biol Phys. 2023 Jul 1;116(3):521-529. doi: 10.1016/j.ijrobp.2022.12.035. Epub 2022 Dec 31. |
| FG001 | Hormones and RT Plus Chemotherapy | AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT. |
| COMPLETED |
|
| NOT COMPLETED |
|
All eligible patients
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Hormones and RT | Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT). |
| BG001 | Hormones and RT Plus Chemotherapy | AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT. |
| 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 | Overall Survival (5-year Rate Reported) | Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 5 years. | All randomized patients. | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of randomization to the date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Biochemical Failure at 5 Years | Biochemical failure uses the American Society for Radiation Oncology (ASTRO) definition of prostate-specific antigen (PSA) rises on three consecutive occasions, with biochemical failure date being midway between the last non-rising PSA and the first rise in PSA. Time to biochemical failure is defined as time from randomization to biochemical failure, last known follow-up (censored), or death (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. | All randomized patients | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Local Progression at 5 Years | Local progression is defined as documented clinical local and/or regional progression. Time to local progression is defined as time from randomization to local progression, last known follow-up (censored), or death (competing risk). Local progression rates are estimated using the cumulative incidence method. | All randomized patients | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years. |
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| Secondary | Rate of Distant Metastasis at Five Years | Distant metastasis (DM) is defined as documented metastatic disease. Time to distant metastasis is defined as time from randomization to distant metastatic disease, last known follow-up (censored), or death (competing risk). Distant metastasis rates are estimated using the cumulative incidence method. | All randomized patients | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years. |
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| Secondary | Disease-free Survival Rate at 5 Years | Disease-free survival (DFS) was measured from the date of randomization to the date of documentation of progression (local, distant, biochemical failure), death, or last follow-up (censored). The Kaplan-Meier method was used to estimate DFS rates. | All randomized patients | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years. |
|
Not provided
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 | Hormones and RT | AS (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and Casodex or Eulexin). Androgen suppression will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of RT. | 6 | 197 | 189 | 197 | ||
| EG001 | Hormones and RT Plus Chemotherapy | AS (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and Casodex or Eulexin) and chemotherapy. Androgen suppression will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT. | 70 | 200 | 198 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ferbrile neutropenia | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Packed red blood cell transfusion | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Supraventricular arrhythmia NOS | Cardiac disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Abdominal pain NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Diarrhea NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Esophagitis NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Bowel: NOS | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Proctitis NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pain-other | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Infection NOS | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Infection with grade 3 or 4 neutropenia | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Infection, Other | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Leukopenia NOS | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Neutropenia | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyperglycemia NOS | 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 |
| |
| Secondary malignancy, Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTC (2.0) | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hematuria present | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Bladder: NOS | Renal and urinary disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dyspnea NOS | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pulmonary-other | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Thrombosis NOS | 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 decreased | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Edema NOS | Cardiac disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Diarrhea NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Bowel: NOS | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Other GI: NOS | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Proctitis NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Rectal bleeding | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Other: NOS | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Pain-other | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dermatitis radiation NOS | Injury, poisoning and procedural complications | CTC (2.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Leukopenia NOS | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Neutropenia | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Blood albumin decreased | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyperglycemia NOS | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Taste disturbance | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Depression NEC | Psychiatric disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hematuria present | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Bladder: NOS | Renal and urinary disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Renal/GU-Other | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Impotence | Reproductive system and breast disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Other GU: NOS | Reproductive system and breast disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Dyspnea NOS | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dermatitis exfoliative NOS | Skin and subcutaneous tissue disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Menopausal symptoms | 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 | wseiferheld@nrgoncology.org |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C053541 | bicalutamide |
| D004961 | Estramustine |
| D005047 | Etoposide |
| D005485 | Flutamide |
| D017239 | Paclitaxel |
| D007987 | Gonadotropin-Releasing Hormone |
| D011878 | Radiotherapy |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D013812 | Therapeutics |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
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