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Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer Clinical research trials and Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer. Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer clinical trial. Human subjects often get the best healthcare possible for their Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer  Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer
Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer
For Condition: cervical squamous cell carcinoma,stage 2A cervical cancer,stage 1B cervical cancer,cervical adenosquamous cell carcinoma,cervical adenocarcinoma
Status: No longer recruiting
Sponsor(s): EORTC Gynecological Cancer Cooperative Group , Medical Research Council
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 chemotherapy with radiation therapy may kill more tumor cells. It is not yet known whether giving radiation therapy with chemotherapy after surgery is more effective than radiation therapy alone after surgery in treating cervical cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy after surgery in treating patients with stage IB or stage IIA cervical cancer.
Details: OBJECTIVES: I. Compare relapse free and overall survival after radiation therapy with or without the sequential use of chemotherapy in patients with node positive stage IB or IIA cervical cancer. II. Compare the toxic effects of these two treatments in this patient population. III. Study the effect of the addition of chemotherapy on the pattern of relapse in these patients. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to institution, stage, site of lymph node involvement, parametrial invasion, resection margin status, diameter of the primary lesion, and preoperative brachtherapy. Patients are assigned to one of two treatment arms and begin therapy within 6 weeks of surgery. Arm I: Patients receive radiation therapy to the pelvis with or without brachytherapy and/or para-aortic irradiation for 4-5 weeks. Arm II: Patients receive radiation therapy as in arm I plus 1 of 5 different cisplatin-based combination chemotherapy regimens. The patients preferably receive chemotherapy before radiation therapy, unless doubtful or positive margins are present, then radiation therapy is given first. Regimen I: Cisplatin and fluorouracil are administered on days 1 and 2 of a 21 day cycle. Patients receive 4 cycles of therapy. Regimen II: Bleomycin is administered on day 1 and cisplatin and ifosfamide are administered on day 2 of a 21 day cycle. Patients receive 4 cycles of therapy. The regimen may also be given without bleomycin. Regimen III: Patients receive vindesine on days 1 and 8, cisplatin on day 1, bleomycin on days 2-4, and mitomycin on day 5 (cycles 1 and 3 only). Each cycle lasts 21 days and patients receive 4 cycles of therapy. Regimen IV: Cisplatin and vinblastine are administered on day 1 and bleomycin is administered on days 1, 8, and 15 of a 21 day cycle. Each patient receives 4 cycles of therapy. Regimen V: Patients receive cisplatin and methotrexate on day 1 of each 14 day cycle. Patients receive 6 cycles of therapy. Patients are followed every 3 months for the first 2 years, every 6 months for the next 3 years, then annually for the next 5 years. PROJECTED ACCRUAL: Approximately 700 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven stage IB or IIA cervical cancer; Squamous cell carcinoma; Adenosquamous cell carcinoma; Adenocarcinoma - Pelvic and/or common iliac or para-aortic lymph node involvement - Undergone a radical hysterectomy, complete pelvic lymphadenectomy, and resection of any enlarged common iliac or para-aortic lymph nodes - No clear cell carcinoma or small cell carcinoma with neuroendocrine differentiation - Resectable disease --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Not specified - Endocrine therapy: Not specified - Radiotherapy: No preoperative external radiotherapy - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: WBC at least 3500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 14.6 mg/dL - Renal: Creatinine no greater than 1.356 mg/dL; Creatinine clearance at least 60 mL/min - Pulmonary: Maximum breathing capacity at least 30 L/min; FEV1 at least 1.0 L No signs of respiratory insufficiency - Other: No potentially active site of infection (e.g., fistula or abscesses); No prior or concurrent second malignancy except adequately treated basal cell carcinoma of the skin
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SergioPecorelli, Study Chair, EORTC Gynecological Cancer Cooperative Group
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
United Kingdom
Derbyshire Royal Infirmary
Derby, England, DE1 2QY
United Kingdom
Additional Information:
Study ID Numbers: CDR0000066064; EORTC-55954,COSA,EU-98061,NSGO-CC-9502
Study Start Date: December 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003209
Other Stage 2a Cervical Cancer Studies:
1. Oxaliplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Cervical Cancer
2. Radiation Therapy, Paclitaxel, and Cisplatin in Treating Patients With Cancer of the Cervix
3. Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer
4. Capecitabine in Treating Patients With Persistent or Recurrent Cervical Cancer
5. Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix
Related Studies:
Other stage 2A cervical cancer Clinical Trials
Other Scotland Clinical Trials
Other Glasgow Clinical Trials
Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer
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