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Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer Clinical research trials and Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer. Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer  Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer
Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer
For Condition: cervical adenocarcinoma,Cervical Cancer,cervical squamous cell carcinoma
Status: Not yet recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: 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. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining radiation therapy with chemotherapy in treating patients who have locally advancedcervical cancer.
Details: OBJECTIVES: - Determine the toxicity of pelvic or extended field radiotherapy, cisplatin, and topotecan in patients with locally advanced cervical cancer. - Determine the maximum tolerated dose (MTD) of topotecan when administered in this regimen in this patient population. - Determine the progression-free survival of patients treated at the MTD. - Determine the overall survival of patients treated at the MTD. - Determine the site of recurrence (local vs distant) in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of topotecan. Patients undergo radiotherapy to the pelvic or pelvic and para-aortic fields 5 days a week for 5-6 weeks. Patients receive cisplatin IV and oral topotecan once weekly for a total of 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 1 of 6 patients experiences dose-limiting toxicity. Once the MTD is determined, an additional cohort of 20 patients receives treatment as above at the MTD. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 4-6 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary invasive carcinoma of the uterine cervix - Stage IB-IVA disease - Any cell type - Histologically or cytologically confirmed metastasis to the para-aortic lymph nodes or candidates for pelvic and para-aortic field radiation (with a negative CT scan of the chest) - No known metastasis to scalene nodes or organs outside the radiation field - No known intraperitoneal metastases - Must enroll within 8 weeks of diagnosis PATIENT CHARACTERISTICS: Age - Not specified Performance status - GOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 Hepatic - Bilirubin 1.5 times normal - SGOT 3 times normal Renal - Creatinine < 2.0 mg/dL - Prior ureteral obstruction allowed provided stent or nephrostomy tube has been placed - No renal abnormalities, such as pelvic kidney, horseshoe kidney, or prior renal transplantation that would require modification of radiation fields Other - Not pregnant - No other malignancy within the past 5 years except nonmelanoma skin cancer - No septicemia or severe infection - No other medical or psychiatric condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for any prior malignancy - No prior cytotoxic chemotherapy for this malignancy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy for any prior malignancy - No prior pelvic or abdominal radiotherapy for this malignancy Surgery - See Patient Characteristics- Renal Other - No prior therapy for this malignancy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterRose, Study Chair, Cleveland Clinic Cancer Center
Additional Information:
Study ID Numbers: CDR0000270680; GOG-9913
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054444
Other Cervical Cancer Studies:
1. Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix
2. Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer
3. Chemotherapy Followed By Surgery Compared With Radiation Therapy Plus Chemotherapy in Treating Patients With Stage IB or Stage II Cervical Cancer
4. Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix
5. EF5 to Detect Tumor Hypoxia in Patients With Stage IIB, Stage IIIB, or Stage IVA Cervical Cancer
Related Studies:
Other Cervical Cancer Clinical Trials
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Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer
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