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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003799 |
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.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Preoperative Radiation Therapy With Concurrent Protracted Continuous Infusion 5-FU and Dose Escalating Oxaliplatin Followed by Surgery, Adjuvant Oxaliplatin, 5-FU, and Leucovorin for Locally Advanced (T3 and T4) Rectal Adenocarcinoma |
Estimated Enrollment: | 20 |
Study Start Date: | May 1999 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed locally advanced, nonmetastatic primary adenocarcinoma of the rectum
Clinically fixed or initially not completely resectable (T4, N0-2, M0) based on the presence of at least one of the following criteria:
No tumor outside of the pelvis, including:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Georgia | |
Emory University Hospital - Atlanta | |
Atlanta, Georgia, United States, 30322 | |
Veterans Affairs Medical Center - Atlanta (Decatur) | |
Decatur, Georgia, United States, 30033 | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Study Chair: | David I. Rosenthal, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000066943, ECOG-1297 |
Study First Received: | November 1, 1999 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00003799 |
Health Authority: | United States: Federal Government |
stage II rectal cancer stage III rectal cancer adenocarcinoma of the rectum |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Leucovorin Intestinal Diseases Rectal Diseases Intestinal Neoplasms Rectal neoplasm |
Calcium, Dietary Oxaliplatin Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Micronutrients |