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Postoperative Evaluation of 5-FU by Bolus Injection vs. 5-FU by Prolonged Venous Infusion Prior to and Following Combined Prolonged Venous Infusion Plus Pelvic XRT vs. Bolus 5-FU Plus Leucovorin Plus Levamisole Prior to and Following Combined Pelvic XRT Plus Bolus 5-FU Plus Leucovorin in Patients With Rectal Cancer, Phase III


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

Postoperative Evaluation of 5-FU by Bolus Injection vs. 5-FU by Prolonged Venous Infusion Prior to and Following Combined Prolonged Venous Infusion Plus Pelvic XRT vs. Bolus 5-FU Plus Leucovorin Plus Levamisole Prior to and Following Combined Pelvic XRT Plus Bolus 5-FU Plus Leucovorin in Patients With Rectal Cancer, Phase III


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 a randomized, multicenter study. Patients are stratified according to type
of prior surgery (abdominoperineal resection vs anterior resection), nodal status (N0 vs N1
vs N2-3), depth of tumor invasion (T1-2 vs T3 vs T4a vs T4b), time from surgery to study
entry (20-45 days vs 46-70 days), participating center, and performance status (0-1 vs 2).
Patients are randomized to one of three treatment arms. Arm I: Patients receive fluorouracil
(5-FU) IV on days 1-5 and 29-33. 5-FU is then given as a continuous infusion beginning on
day 57 and continuing concurrently with radiotherapy for 5 weeks. Following a 28 day break
from treatment patients receive 5-FU IV on days 1-5 of a 28 day course. Postradiotherapy
treatment repeats for a total of 2 courses in the absence of disease progression or
unacceptable toxicity. Arm II: Patients receive 5-FU IV continuously on days 1-42. 5-FU and
radiotherapy are then administered as in arm II. Arm III: Patients receive leucovorin
calcium (CF) IV followed by 5-FU IV on days 1-5 and 29-33. Patients also receive oral
levamisole twice daily on days 1-3, 15-17, 29-31, and 43-45. CF IV and 5-FU IV are then
given on days 57-60 and 85-88 concurrently with radiotherapy. Following a 28 day break from
treatment patients receive CF IV and 5-FU IV on days 1-5 and 29-33 and oral levamisole twice
daily on days 1-3, 15-17, 29-31, and 43-45 in the absence of disease progression or
unacceptable toxicity. All patients receive radiotherapy 5 days per week for 5 weeks
starting on day 57. Patients are followed every 4 months for 2 years, then every 6 months
for 4 years, and then annually until death.

PROJECTED ACCRUAL: A total of 1,800 patients (600 per arm) will be accrued for this study.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival and Relapse-free survival

Outcome Time Frame:

Until death

Safety Issue:

No

Principal Investigator

Stephen R. Smalley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Kansas

Authority:

United States: Federal Government

Study ID:

CDR0000063349

NCT ID:

NCT00002551

Start Date:

March 1994

Completion Date:

October 2008

Related Keywords:

  • Colorectal Cancer
  • stage II rectal cancer
  • stage III rectal cancer
  • adenocarcinoma of the rectum
  • Rectal Neoplasms
  • Colorectal Neoplasms

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Ireland Cancer CenterCleveland, Ohio  44106-5065
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Colorado Cancer Research Program, Inc.Denver, Colorado  80209-5031
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
Quain & Ramstad Clinic, P.C.Bismarck, North Dakota  58501
CCOP - Merit Care HospitalFargo, North Dakota  58122
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Geisinger Clinical and Medical CenterDanville, Pennsylvania  17822-2001
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Medical College of WisconsinMilwaukee, Wisconsin  53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
Veterans Affairs Medical Center - Chicago (Lakeside)Chicago, Illinois  60611
Dana-Farber Cancer InstituteBoston, Massachusetts  02115