Surgery With or Without Chemotherapy and Radiation Therapy in TreatingPatients With Stage I Rectal Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: fluorouracil Drug: leucovorin calcium Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Local Excision Alone or Local Excision Plus Adjuvant Chemoradiation Therapy for Small Distal Rectal Cancers |
| Study Start Date: | July 2001 |
| Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
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.
PROJECTED ACCRUAL: Approximately 320 patients will be accrued for this study within 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the rectum
- T1 or T2 by physical and endoscopic exams
- No T3 lesions by clinical or radiological exam
- Villous adenomas or in situ carcinoma allowed without histologicalconfirmation if clinical appearance of cancer
- No multi-focal disease within the rectum at time of initial diagnosis
- No non-adenocarcinomatous rectal cancer or anal cancer
- Less than 4 cm at greatest diameter
- Less than 40% of rectal wall circumference involved
- Proximal margin no greater than 8 cm from dentate line
- No tumor fixation to the perirectal tissues regardless of size
No malignant regional lymph node or distant metastases by clinical exam orradiographical imaging
- No palpable perirectal lymph nodes or nodes larger than 1 cm
- No evidence of malignant perirectal lymph nodes by endorectal ultrasound orendorectal MRI
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- CTC 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 times normal
Renal:
- Creatinine less than 1.8 mg/dL
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other prior or concurrent malignancy within the past 5 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- No prior surgery for rectal cancer including prior attempts at transanal or transcoccygeal surgical excision with unclear or positive margins
- Prior incision or operative biopsy or colonoscopic removal allowed
Contacts and Locations
Show 180 Study Locations| Study Chair: | Ronald Bleday, MD | Dana-Farber/Brigham and Women's Cancer Center |
| Study Chair: | Morton S. Kahlenberg, MD | University of Texas Health Science Center at San Antonio |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00023751 History of Changes |
| Other Study ID Numbers: | CDR0000068858, CLB-80002, SWOG-C80002 |
| Study First Received: | September 13, 2001 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I rectal cancer adenocarcinoma of the rectum |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Colonic Diseases Adjuvants, Immunologic Fluorouracil Leucovorin |
Levoleucovorin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes |
ClinicalTrials.gov processed this record on May 22, 2013