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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000068472 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as cisplatin, 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 radiation therapy with chemotherapy may kill more tumor cells. Drugs such as amifostine may protect normal cells from the side effects of radiation therapy.
PURPOSE: Phase I/II trial to study the effectiveness of combining cisplatin and radiation therapy with or without amifostine in treating patients who have stage IIIB or stage IVA cancer of the cervix.
OBJECTIVES:
OUTLINE:
Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation therapy plus cisplatin | Experimental | Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin. |
|
| Radiation therapy plus cisplatin and amifostine | Experimental | Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amifostine trihydrate | Drug | Amifostine will be delivered before each radiation treatment. Amifostine (500 mg) will be given as two equally-divided subcutaneous injections. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia) | To determine the feasibility and tolerance of extended-field external radiotherapy to the pelvis and para-aortic region and intracavitary irradiation combined with weekly cisplatin using the rate of acute grade 3/4 toxicity rate (excluding grade 3 leukopenia). The first part of this study was designed to determine the acute grade 3/4 toxicity rate (excluding grade 3 leukopenia), to have a starting point for the second part (second arm) of the study. | From start of treatment to 90 days |
| Number of Patients With Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia) | The second part of this study (second arm) was designed to detect a 40% relative reduction (absolute from 77% to 46%) in the acute grade 3/4 toxicity (excluding grade 3 leukopenia) rate, with the addition of amifostine. A one-sided alpha of 0.05 and 80% power required 16 evaluable patients to detect the hypothesized difference. If ≤ 8 had the toxicity, it would be concluded that adding amifostine decreased this toxicity rate by at least 40%. | From start of treatment to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Tumor Control | From registration to date of pelvic tumor failure or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. | |
| Distant Metastases | From registration to date of distant mets or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. |
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DISEASE CHARACTERISTICS:
Histologically proven, locally advanced carcinoma of the uterine cervix
TNM classification stage IIIB or IVA
Disease metastatic to para-aortic or high common iliac lymph nodes
The following cellular types are eligible:
The following cellular types are ineligible:
No metastatic disease outside of the pelvis (except to the para-aortic nodes)
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 |
|---|---|---|
| William Small, MD | Robert H. Lurie Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Cancer Institute - Jacksonville | Jacksonville | Florida | 32207 | United States | ||
| Florida Oncology Associates at Southside Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22193645 | Background | Viswanathan AN, Moughan J, Small W Jr, Levenback C, Iyer R, Hymes S, Dicker AP, Miller B, Erickson B, Gaffney DK. The quality of cervical cancer brachytherapy implantation and the impact on local recurrence and disease-free survival in radiation therapy oncology group prospective trials 0116 and 0128. Int J Gynecol Cancer. 2012 Jan;22(1):123-31. doi: 10.1097/IGC.0b013e31823ae3c9. | |
| 21892091 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiation Therapy Plus Cisplatin | Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin. |
| FG001 | Radiation Therapy Plus Cisplatin & Amifostine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Cisplatin | Drug | Cisplatin will be given weekly with external beam radiation therapy and once with brachytherapy for a total of six doses. Patients receive 40 mg/m^2 by IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36. |
|
| Intracavitary brachytherapy | Radiation | For low dose rate (LDR) brachytherapy, cesium will be given in one to two intracavitary applications, within two weeks of completion of external radiation. The interval between the two applications will be one to three weeks. It is recommended that the total course of treatment be completed in less than eight weeks. High dose rate (HDR) brachytherapy may start as early as week two of external radiation. The minimum cumulative external and intracavitary dose should be 85 Gy. |
|
| External beam radiation therapy | Radiation | Patients will receive 1.8 Gy daily for five weeks for a total dose of 45 Gy; involved lateral parametrium and/or pelvic nodes should be boosted for a total dose (including intracavitary treatment) of 60 Gy ± 5%. |
|
| Jacksonville |
| Florida |
| 32207 |
| United States |
| Integrated Community Oncology Network | Jacksonville Beach | Florida | 32250 | United States |
| Baptist Medical Center South | Jascksonville | Florida | 32258 | United States |
| Florida Oncology Associates | Orange Park | Florida | 32073 | United States |
| Florida Cancer Center - Palatka | Palatka | Florida | 32177 | United States |
| Flagler Cancer Center | Saint Augustine | Florida | 32086 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| Borgess Medical Center | Kalamazooaa | Michigan | 49001 | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton | New Jersey | 08053 | United States |
| Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare | Vineland | New Jersey | 08360 | United States |
| Akron City Hospital | Akron | Ohio | 44309-2090 | United States |
| Cancer Treatment Center | Wooster | Ohio | 44691 | United States |
| Mercy Cancer Institute at Mercy Hospital | Pittsburgh | Pennsylvania | 15219 | United States |
| Result |
| Small W Jr, Winter K, Levenback C, Iyer R, Hymes SR, Jhingran A, Gaffney D, Erickson B, Greven K. Extended-field irradiation and intracavitary brachytherapy combined with cisplatin and amifostine for cervical cancer with positive para-aortic or high common iliac lymph nodes: results of arm II of Radiation Therapy Oncology Group (RTOG) 0116. Int J Gynecol Cancer. 2011 Oct;21(7):1266-75. doi: 10.1097/IGC.0b013e31822c2769. |
| 17398031 | Result | Small W Jr, Winter K, Levenback C, Iyer R, Gaffney D, Asbell S, Erickson B, Jhingran A, Greven K. Extended-field irradiation and intracavitary brachytherapy combined with cisplatin chemotherapy for cervical cancer with positive para-aortic or high common iliac lymph nodes: results of ARM 1 of RTOG 0116. Int J Radiat Oncol Biol Phys. 2007 Jul 15;68(4):1081-7. doi: 10.1016/j.ijrobp.2007.01.026. Epub 2007 Mar 29. |
Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All eligible patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiation Therapy Plus Cisplatin | Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin. |
| BG001 | Radiation Therapy Plus Cisplatin & Amifostine | Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate. |
| 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 | Rate of Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia) | To determine the feasibility and tolerance of extended-field external radiotherapy to the pelvis and para-aortic region and intracavitary irradiation combined with weekly cisplatin using the rate of acute grade 3/4 toxicity rate (excluding grade 3 leukopenia). The first part of this study was designed to determine the acute grade 3/4 toxicity rate (excluding grade 3 leukopenia), to have a starting point for the second part (second arm) of the study. | All eligible patients | Posted | Number | 95% Confidence Interval | percentage of participants | From start of treatment to 90 days |
|
|
| |||||||||||||||||||||||||
| Primary | Number of Patients With Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia) | The second part of this study (second arm) was designed to detect a 40% relative reduction (absolute from 77% to 46%) in the acute grade 3/4 toxicity (excluding grade 3 leukopenia) rate, with the addition of amifostine. A one-sided alpha of 0.05 and 80% power required 16 evaluable patients to detect the hypothesized difference. If ≤ 8 had the toxicity, it would be concluded that adding amifostine decreased this toxicity rate by at least 40%. | All eligible patients | Posted | Number | participants | From start of treatment to 90 days |
|
| |||||||||||||||||||||||||||
| Secondary | Pelvic Tumor Control | Not Posted | From registration to date of pelvic tumor failure or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. | |||||||||||||||||||||||||||||||||
| Secondary | Distant Metastases | Not Posted | From registration to date of distant mets or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. |
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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 Plus Cisplatin | Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin. | 20 | 26 | 26 | 26 | ||
| EG001 | Radiation Therapy Plus Cisplatin & Amifostine | Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate. | 12 | 15 | 15 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Packed red blood cell transfusion | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Myocardial ischaemia | 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 |
| |
| Gastric ulcer | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Small/Lg Intestine: NOS | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal 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 |
| |
| Infection NOS | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase 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 |
| |
| Blood magnesium decreased | Metabolism and nutrition disorders | 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 |
| |
| 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 |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dyspnea NOS | 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 |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hearing-Other | Ear and labyrinth disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Abdominal pain NOS | Gastrointestinal 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 |
| |
| Dyspepsia | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Small/Lg Intestine: NOS | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Rectal bleeding | 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 due to radiation | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pain-other | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Infection NOS | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Dermatitis radiation NOS | Injury, poisoning and procedural complications | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Skin (within the irradiated field): NOS | Injury, poisoning and procedural complications | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Blood alkaline phosphatase NOS 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 |
| |
| 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 |
| |
| Blood magnesium decreased | Metabolism and nutrition disorders | 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 |
| |
| Hyperkalemia | 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 |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Bone: NOS | Musculoskeletal and connective tissue disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Dizziness (exc vertigo) | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dysuria | 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 |
| |
| Late RT Toxicity: Kidney: NOS | Renal and urinary disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pelvic pain NOS | Reproductive system and breast disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Vaginal hemorrhage | Reproductive system and breast disorders | CTC (2.0) | Non-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 | seiferheldw@nrgoncology.org |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D011832 | Radiation Injuries |
| 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 |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D004999 | Amifostine |
| C007638 | ethanethiol |
| D002945 | Cisplatin |
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D063086 | Organothiophosphates |
| D010755 | Organophosphates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D009946 | Organothiophosphorus Compounds |
| D013457 | Sulfur Compounds |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
|