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Immediate Compared With Delayed Chemotherapy in Advanced Colorectal Cancer Without Signs or Symptoms of Disease

NCT00002570 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2020-04-06

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which treatment regimen is more effective for colorectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of immediate with delayed fluorouracil plus leucovorin in treating patients with advanced colorectal cancer without signs or symptoms of disease.

Conditions

Interventions

DRUG

fluorouracil

425 mg/m2 IV by bolus injection daily for 5 consecutive days q 28 days

DRUG

leucovorin calcium

20 mg/m2 IV - number of cycles is determined by patient and physician

Sponsors & Collaborators

  • North Central Cancer Treatment Group

    collaborator NETWORK

  • NCIC Clinical Trials Group

    lead NETWORK

Principal Investigators

  • Malcolm J. Moore, MD · Princess Margaret Hospital, Canada

  • Henry C. Pitot, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1994-07-15
Primary Completion
2000-11-30
Completion
2009-02-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00002570 on ClinicalTrials.gov