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

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ClinicalTrials.gov Identifier: NCT00023751

Recruitment Status : Completed

First Posted : January 27, 2003

Last Update Posted : July 6, 2016

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Alliance for Clinical Trials in Oncology

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer	Drug: fluorouracil Drug: leucovorin calcium Procedure: conventional surgery Radiation: radiation therapy	Phase 2

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	320 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
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
Actual Primary Completion Date :	April 2004
Actual Study Completion Date :	April 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Fluorouracil Leucovorin

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: surgery + leucovorin + fluorouracil + radiation 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.	Drug: fluorouracil Drug: leucovorin calcium Procedure: conventional surgery Radiation: radiation therapy

Arm

Intervention/treatment

Experimental: surgery + leucovorin + fluorouracil + radiation

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.

Patients are followed every 3 months for 2 years and then every 6 months for 5 years.

Drug: fluorouracil
Drug: leucovorin calcium
Procedure: conventional surgery
Radiation: radiation therapy

Outcome Measures

Primary Outcome Measures :

disease-free survival [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :

overall survival [ Time Frame: Up to 5 years ]
colostomy-free survival [ Time Frame: Up to 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00023751

Show 180 Study Locations

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology

National Cancer Institute (NCI)

Investigators


Study Chair:	Ronald Bleday, MD	Dana-Farber/Brigham and Women's Cancer Center

More Information


Responsible Party:	Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:	NCT00023751 History of Changes
Other Study ID Numbers:	CALGB-80002 U10CA031946 ( U.S. NIH Grant/Contract ) CLB-80002 SWOG-C80002 CDR0000068858 ( Registry Identifier: NCI Physician Data Query )
First Posted:	January 27, 2003 Key Record Dates
Last Update Posted:	July 6, 2016
Last Verified:	July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:


stage I rectal cancer adenocarcinoma of the rectum

Additional relevant MeSH terms:


Colorectal Neoplasms Rectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Fluorouracil Levoleucovorin	Leucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antidotes Protective Agents Vitamin B Complex Vitamins Micronutrients Growth Substances

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