NCT00023751

Surgery With or Without Chemotherapy and Radiation Therapy in TreatingPatients With Stage I Rectal Cancer

A Phase II Study of Local Excision Alone or Local Excision Plus Adjuvant Chemoradiation Therapy for Small Distal Rectal Cancers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 surgery with chemotherapy and radiation therapy may kill more tumor cells and prevent recurrence of the cancer. PURPOSE: Phase II trial to study the effectiveness of surgery with or without chemotherapy and radiation therapy in treating patients who have stage I rectal cancer.

Detailed description

OBJECTIVES: * Determine the overall, disease-free, and colostomy-free survival rates in patients with stage I rectal cancer treated with local excision with or without adjuvant chemotherapy and radiotherapy. * Determine the local, regional, and distant recurrence rates in patients treated with these regimens. * Determine whether loco-regional recurrences after local excision can be successfully salvaged with radical surgery with or without adjuvant therapy for permanent cure in patients treated with these regimens. * Determine whether the analysis of certain histological and molecular markers can help determine prognosis in patients treated with these regimens. * Determine the anorectal, urinary, and sexual function effects in patients treated with these regimens. * Determine the non-functional treatment morbidity and mortality exclusive of anorectal, urinary, and sexual function effects in patients treated with these regimens. * Determine the overall survival of patients with pathology exclusions undergoing local excision. * Determine the efficacy of the current standard in detecting recurrence during follow-up, including office visits, blood tests, and proctoscopy in patients treated with these regimens. OUTLINE: This is a multicenter study. All patients undergo full thickness disc excision. Patients with T3 disease or positive surgical margins after surgery are removed from study. Patients with T1 disease and negative surgical margins after surgery are observed. Patients with T2 disease and negative surgical margins after surgery receive adjuvant therapy. Beginning 42 days after surgery, T2 patients receive leucovorin calcium (CF) IV over 2 hours with fluorouracil (5-FU) IV bolus 1 hour into the infusion once weekly for 6 weeks. Beginning 2 weeks after the completion of chemotherapy, patients receive chemoradiotherapy comprising radiotherapy once daily 5 times a week for 5 weeks and 5-FU IV continuously while receiving radiotherapy. Beginning 2 weeks after the completion of chemoradiotherapy, patients again receive CF IV over 2 hours with 5-FU IV bolus 1 hour into the infusion once weekly for 6 weeks. Chemotherapy repeats after 2 weeks rest for a total of 2 courses. Patients are followed every 3 months for 2 years and then every 6 months for 5 years.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	fluorouracil
DRUG	leucovorin calcium
PROCEDURE	conventional surgery
RADIATION	radiation therapy

Timeline

• Start date: 2001-07-01
• Primary completion: 2004-04-01
• Completion: 2004-04-01
• First posted: 2003-01-27
• Last updated: 2016-07-06

Locations

180 sites across 3 countries: United States, Canada, Puerto Rico