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Palliative Chemotherapy in Treating Patients With Advanced Colorectal 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 Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer Clinical research trials and Palliative Chemotherapy in Treating Patients With Advanced Colorectal 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 Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer. Palliative Chemotherapy in Treating Patients With Advanced Colorectal 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 Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer clinical trial. Human subjects often get the best healthcare possible for their Palliative Chemotherapy in Treating Patients With Advanced Colorectal 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 > "P" Clinical Trials Conditions > Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer  Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer
Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer
For Condition: adenocarcinoma of the rectum,recurrent rectal cancer,adenocarcinoma of the colon,Stage 4 rectal cancer,stage 4 colon cancer,stage 3 rectal cancer,childhood gastrointestinal cancer,stage 3 colon cancer,Quality of Life,recurrent colon cancer
Status: No longer recruiting
Sponsor(s): Medical Research Council ,
Synopsis: RATIONALE: Palliative chemotherapy may help patients with advanced colorectal cancer live longer and more comfortably. PURPOSE: Randomized phase III trial to compare the effectiveness of and quality of life following three different palliative chemotherapy regimens in treating patients with advanced metastatic or recurrent colorectal cancer.
Details: OBJECTIVES: I. Compare the survival and quality of life of patients with metastatic or recurrent colorectal cancer receiving palliative therapy with leucovorin/fluorouracil vs. continuous-infusion fluorouracil vs. ICI D1694. II. Compare the survival and quality of life of patients with stable or responding disease after 12 weeks of initial treatment randomized to receive 12 additional weeks of chemotherapy vs. no further treatment. PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution. Patients are randomized to one of three treatment regimens. The first group receives leucovorin followed by fluorouracil every 14 days for a total of 6 courses. The second group receives continuous-infusion fluorouracil for 12 weeks. The third group receive ICI D1694 every 21 days for a total of 4 courses. Patients without progressive disease or excessive toxicity after 12 weeks of treatment are then randomized to receive continuing chemotherapy in 12 weekly cycles of their assigned chemotherapy or to proceed to observation with no further therapy, until evidence of disease progression. Patients are followed every 6 weeks. PROJECTED ACCRUAL: A total of 900 patients will be entered.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed adenocarcinoma of the colon or rectum in one of the following categories: Locally advanced, metastatic, or recurrent disease suitable only for palliative chemotherapy - Evaluable disease outside prior radiotherapy field - Patients with disease confined to the liver are referred to protocol MRC-CR05 --Prior/Concurrent Therapy-- - No prior systemic chemotherapy except fluorouracil-based adjuvant regimen (e.g., QUASAR); At least 6 months since chemotherapy --Patient Characteristics-- - Age: Not specified - Performance status: WHO 0-2 - Life expectancy: Greater than 3 months - Hematopoietic: WBC at least 4,000 ANC at least 2,000; Platelets at least 100,000 - Hepatic: Not specified - Renal: Creatinine no greater than 1.25 times normal OR Creatinine clearance greater than 65 mL/min - Cardiovascular: No uncontrolled heart failure; No uncontrolled angina - Other: No uncontrolled medical illness (including infection); Able and willing to complete quality-of-life questionnaires; No prior or concurrent malignancy likely to interfere with protocol treatment or evaluation
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TimothyMaughan, Study Chair, Medical Research Council
Velindre Hospital
Cardiff, Wales, CF4 7XL
United Kingdom
Additional Information:
Study ID Numbers: CDR0000065216; MRC-CR06,EU-96049
Study Start Date: June 1995
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002893
Other Stage 3 Colon Cancer Studies:
1. Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer
2. Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer
3. Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
4. Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed
5. SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer
Related Studies:
Other stage 3 colon cancer Clinical Trials
Other Wales Clinical Trials
Other Cardiff Clinical Trials
Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer
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