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Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients with Primary Anal Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients with Primary Anal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients with Primary Anal Cancer Clinical research trials and Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients with Primary Anal Cancer medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients with Primary Anal Cancer. Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients with Primary Anal Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients with Primary Anal Cancer clinical trial. Test subjects typically obtain the finest healthcare available for their Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients with Primary Anal Cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients with Primary Anal Cancer  Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients with Primary Anal Cancer
Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients with Primary Anal Cancer
For Condition: Anal Cancer,squamous cell carcinoma of the anus,cloacogenic carcinoma of the anus,basaloid carcinoma of the anus
Status: Recruiting
Sponsor(s): National Cancer Research Institute (NCRI) ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to kill 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 if fluorouracil plus radiation therapy is more effective with or without additional chemotherapy in treating anal cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of fluorouracil plus radiation therapy with or without additional chemotherapy in treating patients who have primary anal cancer.
Details: OBJECTIVES: - Compare the response rates in patients with primary epidermoid anal cancer treated with radiotherapy and fluorouracil with either mitomycin or cisplatin and with or without maintenance therapy. - Compare local control and prevention or delay of disease dissemination in patients treated with these regimens. OUTLINE: This is randomized, open-label, multicenter study. Patients are randomized to one of four treatment arms. All patients undergo radiotherapy daily 5 days a week for 5.5 weeks. All patients also receive fluorouracil IV continuously over days 1-4 and 29-32. - Arm I: Patients receive mitomycin IV on day 1. - Arm II: Patients receive cisplatin IV on days 1 and 29. - Arm III: Patients receive mitomycin as in arm I and maintenance therapy comprising fluorouracil IV continuously over days 1-4 and cisplatin IV on day 1 beginning 4-8 weeks after completion of primary therapy and repeating once 3 weeks later. - Arm IV: Patients receive cisplatin as in arm II and maintenance therapy as in arm III. Patients are followed at 2 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 600 patients (150 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary epidermoid anal cancer - Squamous cell - Basaloid - Cloacogenic - No adenocarcinoma, malignant melanoma, mucoepidermoid carcinoma, lymphoma, or microinvasive anal intraepithelial neoplasia (without evidence of invasive disease) in the anal canal or margin - No metastatic disease PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - 0-2 Life expectancy: - Not specified Hematopoietic: - WBC greater than 3,000/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 10 g/dL Hepatic: - Liver function tests no greater than 2 times normal Renal: - Glomerular filtration rate at least 50 mL/min Cardiovascular: - No cardiovascular disease - No uncontrolled angina pectoris - No heart failure - No clinically significant cardiac arrhythmias Other: - HIV negative - No other significant concurrent illness - Not predominately bed-bound or frail - No severe sepsis - No other prior or concurrent cancer or illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to pelvis Surgery: - Not specified Other: - No prior therapy for anal cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RogerJames, Study Chair, Maidstone Hospital
Ipswich Hospital NHS Trust *Recruiting*
Ipswich, England, IP4 5PD
United Kingdom
Recruiting Tim Podd 44-1473-712-233
Saint Bartholomew's Hospital *Recruiting*
London, England, EC1A 7BE
United Kingdom
Recruiting Maurice Slevin 44-171-606-6662
Southend NHS Trust Hospital *Recruiting*
Westcliff-On-Sea, England, SS0 0RY
United Kingdom
Recruiting Anne Robinson 44-1702-221-226
Mount Vernon Hospital *Recruiting*
Northwood, England, HA6 2RN
United Kingdom
Recruiting Robert Glynne-Jones 44-1923-844-012
Cancer Research UK and University College London Cancer Trials Unit *Recruiting*
London, England, NW1 2ND
United Kingdom
Recruiting Jonathan Ledermann 44-20-7679-8040
Velindre Cancer Center at Velinde Hospital *Recruiting*
Cardiff, Wales, CF14 2TL
United Kingdom
Recruiting Timothy Maughan 029-20-316206
Cookridge Hospital at Leeds Teaching Hospital NHS Trust *Recruiting*
Leeds, England, LS16 6QB
United Kingdom
Recruiting David Sebag-Montefiore 13-392-4244
Royal Marsden Hospital - Sutton *Recruiting*
Sutton, England, SM2 5PT
United Kingdom
Recruiting David Cunningham 44-208-642-6011
Aberdeen Royal Infirmary *Recruiting*
Aberdeen, Scotland, AB25 2ZN
United Kingdom
Recruiting Les Samuel 224-553-499
Weston Park Hospital *Recruiting*
Sheffield, England, S1O 2SJ
United Kingdom
Recruiting Brian Orr 44-114-226-5000
Northwick Park Hospital *Recruiting*
Harrow, England, HA1 3UJ
United Kingdom
Recruiting John Northover 44-20-864-3232
South Tees Hospitals NHS Trust *Recruiting*
Middlesbrough, Cleveland, England, TS4 3BW
United Kingdom
Recruiting Johannes der Voet 44-1642-850-850
Nottingham City Hospital NHS Trust *Recruiting*
Nottingham, England, NG5 1PB
United Kingdom
Recruiting David Morgan 44-115-969-1169
Additional Information:
Study ID Numbers: CDR0000068911; UKCCCR-ACT-II,NCRI-ACT-II,EU-20056
Study Start Date:
Record last reviewed: March 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025090
Other Basaloid Carcinoma Of The Anus Studies:
1. Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients with Primary Anal Cancer
2. Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
3. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
Related Studies:
Other basaloid carcinoma of the anus Clinical Trials
Other Wales Clinical Trials
Other Cardiff Clinical Trials
Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients with Primary Anal Cancer
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