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Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Rectal Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Rectal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Rectal Cancer Clinical research trials and Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Rectal Cancer healthcare trials happen in hundreds of localities 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Rectal Cancer. Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Rectal Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Rectal Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Rectal Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Rectal Cancer  Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Rectal Cancer
Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Rectal Cancer
For Condition: stage 2 rectal cancer,stage 3 rectal cancer,adenocarcinoma of the rectum
Status: No longer recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
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, radiation therapy, and surgery may be effective treatment for rectal cancer. PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus chemotherapy followed by surgery and additional chemotherapy in treating patients who have advanced nonmetastatic primary cancer of the rectum.
Details: OBJECTIVES: - Determine the maximum tolerated dose and dose-limiting toxicity of oxaliplatin when combined preoperatively with concurrent radiotherapy and fluorouracil in patients with locally advanced rectal adenocarcinoma. - Evaluate the resection rate for T4 rectal cancers, the pathological complete response rate for T3 and T4 rectal cancers, and the expected vs actual type of resection (abdominoperineal resection vs low anterior resection [LAR] vs LAR/coloanal anastomosis) in patients treated with this regimen. - Determine survival and patterns of recurrence in this patient population after this treatment regimen. - Evaluate anastomotic and sphincter function in these patients after preoperative combined modality therapy. OUTLINE: This is a dose-escalation study of preoperative oxaliplatin. Patients receive fluorouracil IV continuously with concurrent radiotherapy for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on day 1 of weeks 1, 3, and 5. Cohorts of 5 patients each receive escalating doses of oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 5 patients experience dose-limiting toxicity. Additional patients are treated at the MTD. Patients undergo surgery 6-8 weeks after completing preoperative chemotherapy and radiotherapy. The surgical procedure is determined by the extent of the tumor before preoperative therapy. The type of operative procedure may be abdominoperineal resection, low anterior resection (LAR), or LAR/coloanal anastomosis. Postoperative chemotherapy begins within 6 weeks after surgery, comprising leucovorin calcium and fluorouracil IV on days 1-5. Treatment repeats every 21 days for 4 courses. Patients are followed every 3 months for 2.5 years, every 6 months for 3 years, then annually for 5 years. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed locally advanced, nonmetastatic primary adenocarcinoma of the rectum - Stage II or III (T3 or T4) - Clinically resectable OR - Clinically fixed or initially not completely resectable (T4, N0-2, M0) based on the presence of at least one of the following criteria: - Clinically fixed tumor on rectal exam with tumor adherent to the pelvic sidewall or sacrum - Sciatica attributed to sacral root invasion with CT scan/MRI evidence of lack of clear tissue plane as evidence of fixation - Hydronephrosis on CT scan or IVP, or ureteric or bladder invasion by cystoscopy and cytology or biopsy, or invasion into prostate - Vaginal or uterine involvement - No tumor outside of the pelvis, including: - Liver metastases - Peritoneal seeding - Metastatic inguinal lymphadenopathy - Distal border of tumor must be at or below the peritoneal reflection, defined as within 12 cm of anal verge by proctoscopic exam - Transmural penetration through the muscularis propria demonstrated by CT scan plus endorectal ultrasound or MRI - No high-grade (lumen diameter less than 1 cm) large bowel obstruction, unless diverting colostomy has been performed PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 3500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin less than 2.0 mg/dL - Alkaline phosphatase no greater than 2 times upper limit of normal (ULN) - SGOT no greater than 2 times ULN Renal: - Creatinine no greater than 2.0 mg/dL Other: - Caloric intake at least 1500 kilocalories per day - No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No active inflammatory bowel disease - No other serious medical illness - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior pelvic radiotherapy - No concurrent intraoperative radiotherapy or brachytherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidRosenthal, Study Chair, M.D. Anderson Cancer Center
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Additional Information:
Study ID Numbers: CDR0000066943; E-1297,ECOG-1297
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003799
Other Adenocarcinoma Of The Rectum Studies:
1. Comparison of Adjuvant Chemotherapy Regimens in Treating Patients With Stage II or Stage III Rectal Cancer Who Are Receiving Radiation Therapy and Fluorouracil Before or After Surgery
2. Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
3. Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the Rectum
4. Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer
5. Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer
Related Studies:
Other adenocarcinoma of the rectum Clinical Trials
Other Georgia Clinical Trials
Other Decatur Clinical Trials
Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Rectal Cancer
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