NCT00427310

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving fluorouracil into the liver is more effective than no further treatment for patients with colon cancer undergoing surgery. PURPOSE: This randomized phase III trial is studying giving infusions of fluorouracil into the liver in treating patients with Dukes' A, Dukes' B, or Dukes' C colon cancer undergoing surgery.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,158

participants targeted

Target at P75+ for phase_3 colorectal-cancer

Timeline
Completed

Started Mar 1984

Longer than P75 for phase_3 colorectal-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1984

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 1989

Completed
11.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2001

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
Last Updated

January 3, 2013

Status Verified

December 1, 2012

Enrollment Period

5.5 years

First QC Date

January 18, 2007

Last Update Submit

December 31, 2012

Conditions

Colorectal Cancer

Keywords

stage I colon cancerstage II colon cancerstage III colon canceradenocarcinoma of the colon

Outcome Measures

Primary Outcomes (2)

  • Disease free interval

    Evidence of treatment failure (presence of tumor in local/regional or distant sites, confirmed by either biopsy or other acceptable evidence.

    From randomization up to 4 years.

  • Survival

    From randomization up to 4 years.

Study Arms (2)

Arm 1: Postoperative 5 FU + sodium heparin

EXPERIMENTAL

Continuous portal vein infusion with 5 FU 600 mg/m2 + 5000 units sodium heparin per day given for a total of 7 consecutive days.

Drug: fluorouracilDrug: sodium heparin

Arm 2: Postoperative observation

ACTIVE COMPARATOR
Other: Observation

Interventions

fluorouracilDRUG
Also known as: 5 FU
Arm 1: Postoperative 5 FU + sodium heparin
ObservationOTHER
Arm 2: Postoperative observation
sodium heparinDRUG
Arm 1: Postoperative 5 FU + sodium heparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • more than one synchronous primary colon tumor
  • white blood cell (WBC) \> 4000/cu.mm. and platelet count greater than or equal to 100,000/cu.mm.
  • evidence of adequate renal (serum creatinine less than or equal to 1.5 mg%) and hepatic function (bilirubin less than or equal to 1.5 mg%; serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 60 I.U./ml)
  • performance status of 0, 1 or 2
  • Patients with intestinal obstruction are eligible. Preliminary or complementary colostomy does not preclude entry of a patient provided randomization is carried out prior to the planned curative resection.
  • The distal margin of the tumor must be greater than or equal to 12 cm from the anal verge as endoscopically measured with the patient in the knee-chest position.
  • Carcinoembryonic antigen (CEA) must be performed pre-operatively but results need not be known at the time of randomization.

You may not qualify if:

  • malignant colon tumors other than carcinoma, i.e., sarcoma, lymphoma, etc.
  • patients whose tumors demonstrate free perforation
  • previous or concomitant malignancy, regardless of site - except patients with squamous or basal cell carcinoma of the skin, and carcinoma in situ of the cervix which have been adequately treated
  • patients who have received prior treatment other than preliminary or complementary colostomy (radiation, chemotherapy or surgery) for their current malignancy.
  • patients having tumors within 12 cm of the anal verge
  • performance status of 3 or 4
  • patients having non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) which would preclude their being subject to the chemotherapy treatment option
  • patients who are pregnant at the time of randomization
  • patients with psychiatric or addictive disorders which would preclude obtaining informed consent
  • patients who have multiple primary tumors involving both the colon and the rectum which would preclude them from being classified as having only colon cancer or only rectal cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • O'Connell MJ, Lavery I, Yothers G, Paik S, Clark-Langone KM, Lopatin M, Watson D, Baehner FL, Shak S, Baker J, Cowens JW, Wolmark N. Relationship between tumor gene expression and recurrence in four independent studies of patients with stage II/III colon cancer treated with surgery alone or surgery plus adjuvant fluorouracil plus leucovorin. J Clin Oncol. 2010 Sep 1;28(25):3937-44. doi: 10.1200/JCO.2010.28.9538. Epub 2010 Aug 2.

    PMID: 20679606BACKGROUND

  • Wilkinson NW, Yothers G, Lopa S, Costantino JP, Petrelli NJ, Wolmark N. Long-term survival results of surgery alone versus surgery plus 5-fluorouracil and leucovorin for stage II and stage III colon cancer: pooled analysis of NSABP C-01 through C-05. A baseline from which to compare modern adjuvant trials. Ann Surg Oncol. 2010 Apr;17(4):959-66. doi: 10.1245/s10434-009-0881-y.

    PMID: 20082144BACKGROUND

  • Wilkinson NW, Yothers G, Lopa SH, et al.: Long-term survival results of surgery alone compared with surgery plus 5-fluorouracil and leucovorin for stage II and stage III colon cancer: pooled analysis of NSABP adjuvant trials C-01 through C-05. [Abstract] American Society of Clinical Oncology 2009 Gastrointestinal Cancers Symposium, 15-17 January 2009, San Francisco, CA. A-442, 2009.

    BACKGROUND

  • Kim GP, Colangelo LH, Wieand HS, Paik S, Kirsch IR, Wolmark N, Allegra CJ; National Cancer Institute. Prognostic and predictive roles of high-degree microsatellite instability in colon cancer: a National Cancer Institute-National Surgical Adjuvant Breast and Bowel Project Collaborative Study. J Clin Oncol. 2007 Mar 1;25(7):767-72. doi: 10.1200/JCO.2006.05.8172. Epub 2007 Jan 16.

    PMID: 17228023BACKGROUND

  • Allegra CJ, Paik S, Colangelo LH, Parr AL, Kirsch I, Kim G, Klein P, Johnston PG, Wolmark N, Wieand HS. Prognostic value of thymidylate synthase, Ki-67, and p53 in patients with Dukes' B and C colon cancer: a National Cancer Institute-National Surgical Adjuvant Breast and Bowel Project collaborative study. J Clin Oncol. 2003 Jan 15;21(2):241-50. doi: 10.1200/JCO.2003.05.044.

    PMID: 12525515BACKGROUND

  • Wolmark N, Colangelo L, Wieand S. National Surgical Adjuvant Breast and Bowel Project trials in colon cancer. Semin Oncol. 2001 Feb;28(1 Suppl 1):9-13. doi: 10.1016/s0093-7754(01)90245-3.

    PMID: 11273592BACKGROUND

  • Dignam JJ, Colangelo L, Tian W, Jones J, Smith R, Wickerham DL, Wolmark N. Outcomes among African-Americans and Caucasians in colon cancer adjuvant therapy trials: findings from the National Surgical Adjuvant Breast and Bowel Project. J Natl Cancer Inst. 1999 Nov 17;91(22):1933-40. doi: 10.1093/jnci/91.22.1933.

    PMID: 10564677BACKGROUND

  • Mamounas E, Wieand S, Wolmark N, Bear HD, Atkins JN, Song K, Jones J, Rockette H. Comparative efficacy of adjuvant chemotherapy in patients with Dukes' B versus Dukes' C colon cancer: results from four National Surgical Adjuvant Breast and Bowel Project adjuvant studies (C-01, C-02, C-03, and C-04). J Clin Oncol. 1999 May;17(5):1349-55. doi: 10.1200/JCO.1999.17.5.1349.

    PMID: 10334518BACKGROUND

  • Wolmark N, Rockette H, Petrelli N, et al.: Long-term results of the efficacy of perioperative portal vein infusion of 5-FU for treatment of colon cancer: NSABP C-02. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-561, 194, 1994.

    RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Neoplasms

Interventions

FluorouracilObservationHeparin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMethodsInvestigative TechniquesGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Norman Wolmark, MD

    NSABP Foundation Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2007

First Posted

January 29, 2007

Study Start

March 1, 1984

Primary Completion

September 1, 1989

Study Completion

February 1, 2001

Last Updated

January 3, 2013

Record last verified: 2012-12