|
Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer Clinical research trials and Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer. Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer clinical trial. Subjects frequently get the best healthcare possible for their Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer  Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer
Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer
For Condition: stage 3 rectal cancer,stage 2 colon cancer,stage 2 rectal cancer,stage 1 rectal cancer,stage 3 colon cancer
Status: No longer recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of fluorouracil - uracil and leucovorin plus radiation therapy in treating patients with colorectal cancer who have undergone surgery to remove the tumor.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of postoperative fluorouracil-uracil plus leucovorin calcium concurrently with radiotherapy in patients with colorectal cancer. II. Determine the toxicity of this regimen in these patients. III. Determine the response of tumors in patients with measurable disease treated with this regimen. PROTOCOL OUTLINE: This is a dose-escalation study of fluorouracil-uracil (UFT). Beginning within 10 weeks after definitive surgery, patients receive oral UFT and oral leucovorin calcium (CF) 3 times a day on days 1-28. Treatment continues every 5 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of the second course, patients undergo radiotherapy to the tumor bed and involved lymph nodes 5 days a week for 5 weeks, followed by boost radiotherapy to the primary tumor bed for 5-16 days. Patients receive 3 additional courses of UFT plus CF beginning 4 weeks after completion of radiotherapy or after recovery from the toxic effects of UFT, whichever occurs later. Patients who have measurable disease with ongoing response after the fifth course receive additional courses of UFT and CF. Cohorts of 3-6 patients receive escalating doses of UFT during the second course until the maximum tolerated dose (MTD) is determined. The MTD is defined as highest dose at which the minority of patients experience dose-limiting toxicity. Patients are followed every 3 months for 1 year and then at the discretion of the investigator. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of colorectal cancer for which postoperative radiotherapy to the pelvis is indicated --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent antineoplastic biological response modifiers - Chemotherapy: No prior systemic chemotherapy - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; No prior radiotherapy to the pelvis - Surgery: See Disease Characteristics - Other: No other concurrent investigational drugs; No other concurrent antineoplastic therapy; No concurrent halogenated antiviral agent (e.g., sorivudine) --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 3 months - Hematopoietic: WBC at least 4,000/mm3; Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; ALT no greater than 1.25 times upper limit of normal (ULN) (no greater than 5 times ULN if elevation secondary to malignancy); Alkaline phosphatase no greater than 1.25 times ULN (no greater than 5 times ULN if elevation secondary to malignancy) - Renal: Creatinine normal OR Creatinine clearance normal or greater than 60 mL/min - Other: No medical or psychiatric condition that would preclude study; No prior malignancy except: Appropriately treated localized epithelial skin or cervical cancer; Remote history of other cured malignancy (at the discretion of the sponsor); Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BruceMinsky, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000064898; MSKCC-96025,NCI-V96-0942,BMS-MSKCC-96025
Study Start Date: April 1996
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002801
Other Stage 1 Rectal Cancer Studies:
1. Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer
2. Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
3. Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
4. Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer
5. Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer
Related Studies:
Other stage 1 rectal cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer
|
|
|
|
|
|
|
|
