NCT00003799

Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Rectal Cancer

Phase I Study of Preoperative Radiation Therapy With Concurrent Protracted Continuous Infusion 5-FU and Dose Escalating Oxaliplatin Followed by Surgery, 5-FU, and Leucovorin for Locally Advanced (T3 and T4) Rectal Adenocarcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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. 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 an effective treatment for rectal cancer

Detailed description

PRIMARY OBJECTIVES: I. To identify maximally tolerated dose (MTD) and dose limiting toxicity (DLT) of oxaliplatin when combined preoperatively with concurrent radiation therapy (XRT) and fluorouracil (5-FU) by PVI. II. To evaluate the resection rate for T4 rectal cancers, the pathologic CR rate for T3 and T4 rectal cancers, and the expected versus actual type of resection (APR vs. LAR vs. LAR/coloanal anastomosis). III. To make preliminary observations of patient survival and patterns of recurrence for this treatment combination. IV. To evaluate anastomotic and sphincter function following pre-op 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.

Conditions

• Adenocarcinoma of the Rectum
• Mucinous Adenocarcinoma of the Rectum
• Signet Ring Adenocarcinoma of the Rectum
• Stage IIA Rectal Cancer
• Stage IIB Rectal Cancer
• Stage IIC Rectal Cancer
• Stage IIIA Rectal Cancer
• Stage IIIB Rectal Cancer
• Stage IIIC Rectal Cancer

Interventions

Type	Name	Description
DRUG	fluorouracil	Given IV
DRUG	oxaliplatin	Given IV
RADIATION	radiation therapy	Undergo radiotherapy
DRUG	leucovorin calcium	Given IV
PROCEDURE	therapeutic conventional surgery	Undergo surgery

Timeline

• Start date: 1999-05-01
• Primary completion: 2003-09-01
• First posted: 2003-01-27
• Last updated: 2013-01-10

Locations

1 site across 1 country: United States