Search / Trial NCT00002551

SWOG-9304 Chemotherapy Plus Radiation Therapy in Treating Patients With Rectal Cancer That Has Been Surgically Removed

Launched by SWOG CANCER RESEARCH NETWORK · Jun 9, 2004

Trial Information

Current as of December 06, 2024

Completed

Keywords

Stage Ii Rectal Cancer Stage Iii Rectal Cancer Adenocarcinoma Of The Rectum

ClinConnect Summary

OBJECTIVES: I. Compare the overall and relapse free survival of patients with stage II or III rectal cancer treated with one of the following three regimens: bolus injections of fluorouracil (5-FU) prior to and following pelvic irradiation plus protracted venous infusion (PVI) 5-FU radiosensitization vs PVI 5-FU prior to and following pelvic irradiation plus PVI 5-FU radiosensitization vs bolus 5-FU with leucovorin calcium and levamisole prior to and following pelvic irradiation. II. Describe relapse patterns and tolerance associated with these regimens in these patients.

OUTLINE: This is ...

Gender

ALL

Eligibility criteria

  • DISEASE CHARACTERISTICS: Histologically proven stage II or III adenocarcinoma of the rectum Tumor extends through the bowel wall and into perirectal fat or soft tissue (TNM T3-4, N0, M0) Nodes are involved with tumor (TNM T1-4, N1-3, M0) Tumor completely resected en bloc with no gross or microscopic evidence of residual disease Circumferential (radial) margins of resected adherent tumors must be specifically documented free of disease (with the sole exception of extraperitoneal serosal margins) No evidence of metastasis No regional nodal metastases (metastases outside of the pelvis) that cannot be resected en bloc with the primary lesion No distant peritoneal metastases (metastases that are not a direct extension from the primary tumor) even if grossly resected (direct extension into another structure permitted) Abdominopelvic CT required unless: Bilirubin, SGOT, and alkaline phosphatase are within normal limits, AND Operative report describes liver as normal on exploration No tumors of colonic origin, i.e.: Lower edge of the tumor is below the peritoneal reflection or a portion of the tumor is retroperitoneally located (usually posteriorly) as defined by the surgeon at laparotomy OR Lower margin of the tumor is 12 cm or less from the anal verge by proctoscopic exam No prior history of rectal cancer No stage II or III cancers of the extrapelvic colon within the past 5 years Complete surgical resection at least 5 years prior to protocol registration allowed provided no other therapy was administered Synchronous modified stage I or IIa colorectal cancer (no nodal involvement or penetration through the muscularis propria) that has been completely resected allowed Registration between 20 and 70 days after the definitive surgical procedure required Chemotherapy must begin no later than day 70 following surgery Concurrent registration on protocol SWOG-9419 allowed for patients with adequate tissue samples
  • PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Hematopoietic: WBC at least 4,000/mm3 Platelet count normal Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Renal: Not specified Other: No chronic ulcerative colitis No other serious medical illness that would preclude protocol therapy No psychiatric condition that would preclude informed consent No noncolorectal malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer Adequately treated carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
  • PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics Other: No other concurrent antineoplastic therapy

Trial Officials

Stephen R. Smalley, MD

Study Chair

University of Kansas

Al B. Benson, MD, FACP

Study Chair

Robert H. Lurie Cancer Center

Jaffer A. Ajani, MD

Study Chair

M.D. Anderson Cancer Center

Michael J. O'Connell, MD

Study Chair

Mayo Clinic

Anthony LA Fields, MD, FRCPC

Study Chair

Cross Cancer Institute at University of Alberta

Robert J. Mayer, MD, FACP

Study Chair

Dana-Farber Cancer Institute

About Swog Cancer Research Network

The SWOG Cancer Research Network is a leading cancer clinical trial organization dedicated to improving cancer treatment and outcomes through innovative research. Comprising a collaborative network of academic institutions, community hospitals, and cancer centers, SWOG conducts rigorous clinical trials that advance the understanding of cancer biology, prevention, and therapy. With a strong emphasis on inclusivity and diversity, SWOG aims to ensure that clinical research reflects the populations affected by cancer, ultimately striving to enhance patient care and quality of life. Through its commitment to scientific excellence and collaboration, SWOG plays a pivotal role in shaping the future of oncology.

Locations

Milwaukee, Wisconsin, United States

Bronx, New York, United States

Tampa, Florida, United States

Ann Arbor, Michigan, United States

Minneapolis, Minnesota, United States

Cleveland, Ohio, United States

Chicago, Illinois, United States

Omaha, Nebraska, United States

Denver, Colorado, United States

Peoria, Illinois, United States

Urbana, Illinois, United States

Des Moines, Iowa, United States

Boston, Massachusetts, United States

Kalamazoo, Michigan, United States

Saint Louis Park, Minnesota, United States

East Orange, New Jersey, United States

Hackensack, New Jersey, United States

Philadelphia, Pennsylvania, United States

Pretoria, , South Africa

Duluth, Minnesota, United States

Scottsdale, Arizona, United States

Cedar Rapids, Iowa, United States

Sioux City, Iowa, United States

New Orleans, Louisiana, United States

Bismarck, North Dakota, United States

Fargo, North Dakota, United States

Grand Forks, North Dakota, United States

Toledo, Ohio, United States

Danville, Pennsylvania, United States

Rapid City, South Dakota, United States

Sioux Falls, South Dakota, United States

Regina, Saskatchewan, Canada

Milwaukee, Wisconsin, United States

Evanston, Illinois, United States

Marshfield, Wisconsin, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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