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| Descriptive Information Fields | |||||
| Brief Title † | Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix | ||||
| Official Title † | A Two Part Phase I/II Study Of Extended Field External Irradiation And Intracavitary Brachytherapy Combined With Chemotherapy (Weekly Cisplatin-Arm1) And Amifostine (Arm 2) In Carcinoma Of The Cervix With Positive Para-Aortic Or High Common Iliac Lymph Nodes | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. PROJECTED ACCRUAL: A total of 40-66 patients (27 for phase I and 13-39 for phase II) will be accrued for this study within 12-30 months. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | Feasibility and tolerability [ Designated as safety issue: Yes ] Toxicity [ Designated as safety issue: Yes ] |
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| Secondary Outcome Measure † | Pelvic tumor control [ Designated as safety issue: No ] Distant metastases [ Designated as safety issue: No ] |
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| Condition † | Cancer-Related Problem/Condition Cervical Cancer |
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| Intervention † | Drug: amifostine trihydrate Drug: cisplatin Procedure: brachytherapy Procedure: radiation therapy |
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| MEDLINE PMIDs | 17398031 | ||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 66 | ||||
| Start Date † | August 2001 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
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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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00012012 | ||||
| Organization ID | CDR0000068472 | ||||
| Secondary IDs †† | RTOG-C-0116 | ||||
| Study Sponsor † | Radiation Therapy Oncology Group | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | February 2007 | ||||
| First Received Date † | March 3, 2001 | ||||
| Last Updated Date | October 18, 2008 | ||||