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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer Clinical research trials and Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer health trials occur in a lot of of places throughout 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 typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer  Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
For Condition: stage 3 anal cancer,stage 2 anal cancer,cloacogenic carcinoma of the anus,squamous cell carcinoma of the anus,basaloid carcinoma of the anus
Status: Recruiting
Sponsor(s): Federation Nationale des Centres de Lutte Contre le Cancer ,
Synopsis: RATIONALE: Drugs used in chemotherapy 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 chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Randomizedphase III trial to compare the effectiveness of different regimens of combination chemotherapy plus radiation therapy in treating patients who have stage II or stage III anal cancer.
Details: OBJECTIVES: - Compare the efficacy of concurrent chemotherapy and radiotherapy with or without neoadjuvant chemotherapy with fluorouracil and cisplatin in patients with stage II or III anal canal cancer. - Compare the efficacy of two levels of radiation dose in patients with stage II or III anal canal cancer. - Compare the sphincter conservation of the anus by these regimens. - Compare the effect of these regimens on survival and quality of life of these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of four treatment arms. - Arm I: Patients receive induction chemotherapy consisting of fluorouracil IV over 24 hours on days 1-4 and cisplatin IV over 1 hour on day 1 or 2 every 4 weeks for 2 courses. Beginning 4 weeks later, patients receive chemoradiotherapy. This regimen consists of fluorouracil IV over 24 hours on days 1-4 and cisplatin IV over 1 hour on day 1 or 2 and repeated 4 weeks later, plus pelvic radiotherapy beginning on day 1 and continuing for 5 weeks (once a day, 5 days/week). Patients receive low dose radiotherapy directly to the tumor beginning 3 weeks later and continuing for 2 weeks. - Arm II: Patients receive induction chemotherapy and chemoradiotherapy as in arm I, plus high dose radiotherapy directly to the tumor. - Arm III (control arm): Patients receive chemoradiotherapy and low dose radiotherapy to the tumor as in arm I. - Arm IV: Patients receive chemoradiotherapy and high dose radiotherapy to the tumor as in arm II. After study treatment is completed, patients with nonfixed inguinal tumors may undergo surgical resection followed by radiotherapy or radiotherapy alone. Patients with fixed inguinal tumors may receive further radiotherapy alone. Quality of life is assessed before treatment, at 2 months after completion of treatment, and at 5 years. Patients are followed every 4 months for 2 years, every 6 months for 3 years, then annually thereafter. PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /80 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven nonmetastatic anal cancer - Anal/rectal junction OR - Anal/cutaneous junction with the majority of the tumor in the anal canal, above the junction - Epidermoid cancer (well-differentiated, fairly differentiated, or basaloid) OR - Cloacogenic cancer - Stage II or III - T2 at least 4 cm OR - T3 OR - T4, N0-3, M0 OR - T1, N1-3 OR - T2 (less than 4 cm), N1-3 - Tumors at least 4 cm in greatest dimension and/or tumors with lymph node invasion must be nonmetastatic by ultrasound - No prior surgery to remove tumor PATIENT CHARACTERISTICS: Age: - 80 and under Performance status: - WHO 0 or 1 Life expectancy: - Not specified Hematopoietic: - WBC at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 11 g/dL (transfusion allowed) Hepatic: - Not specified Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No cardiac condition contraindicating use of fluorouracil Other: - No prior malignancy within 5 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix or breast - No other serious medical or psychological condition - No serious immunosuppression PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic therapy Chemotherapy: - No prior chemotherapy Endocrine therapy: - No prior endocrine therapy Radiotherapy: - No prior pelvic or inguinal radiotherapy Surgery: - See Disease Characteristics - No prior definitive colostomy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DidierPeiffert, Study Chair, Centre Alexis Vautrin
Centre Alexis Vautrin *Recruiting*
Vandoeuvre-les-Nancy, , 54511
France
Recruiting Didier Peiffert 33-3-83-59-84-00
Additional Information:
Study ID Numbers: CDR0000066744; FNCLCC-FFCD-SFRO-ACCORD-3,EU-98050
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003652
Other Squamous Cell Carcinoma Of The Anus Studies:
1. Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
2. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
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Other squamous cell carcinoma of the anus Clinical Trials
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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
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