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Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed

NCT ID: NCT00005586

Last Updated: 2013-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-10-31

Brief Summary

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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 whether chemotherapy is more effective than observation in patients who have had surgery to remove colorectal cancer.

PURPOSE: This randomized phase III trial is studying leucovorin and fluorouracil to see how well they work compared to observation in treating patients with colorectal cancer that has been surgically removed.

Detailed Description

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OBJECTIVES:

* Compare all-cause mortality in patients with resected colorectal cancer treated with adjuvant chemotherapy with L-leucovorin and fluorouracil vs observation.
* Compare the recurrence rates in patients treated with this regimen vs observation.
* Compare the effectiveness of a monthly 5-day schedule vs a once weekly schedule of L-leucovorin and fluorouracil in this patient population.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to receive adjuvant chemotherapy (arm I) or undergo observation only (arm II).

* Arm I: Within 12 weeks of surgery, patients receive L-leucovorin IV followed by fluorouracil IV on days 1-5 every 4 weeks for 6 courses. Alternatively, patients may receive L-leucovorin IV followed by fluorouracil IV on day 1 weekly for 30 weeks.
* Arm II: Patients undergo observation. Patients are followed annually.

PROJECTED ACCRUAL: A total of 2,500 patients (1,250 per arm) will be accrued for this study.

Conditions

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Colorectal Cancer

Keywords

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stage II colon cancer stage III colon cancer stage II rectal cancer stage III rectal cancer

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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L-leucovorin

Intervention Type DRUG

fluorouracil

Intervention Type DRUG

adjuvant therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Completely resected stage II or III colorectal cancer
* No distant metastases
* No positive resection margins
* No positive peritoneal washings

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No clear definite indication for, or contraindication against, systemic chemotherapy with L-leucovorin and fluorouracil

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No concurrent chemotherapy in observation only arm

Endocrine therapy:

* Not specified

Radiotherapy:

* Concurrent radiotherapy allowed in adjuvant chemotherapy arm provided chemotherapy administered on the once weekly schedule

Surgery:

* See Disease Characteristics
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role lead

Principal Investigators

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Norman Williams, MD

Role: STUDY_CHAIR

Royal London Hospital

Locations

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Royal London Hospital

London, England, United Kingdom

Site Status

Countries

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United Kingdom

References

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Quasar Collaborative Group; Gray R, Barnwell J, McConkey C, Hills RK, Williams NS, Kerr DJ. Adjuvant chemotherapy versus observation in patients with colorectal cancer: a randomised study. Lancet. 2007 Dec 15;370(9604):2020-9. doi: 10.1016/S0140-6736(07)61866-2.

Reference Type RESULT
PMID: 18083404 (View on PubMed)

Other Identifiers

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NCRI-QUASAR1

Identifier Type: -

Identifier Source: secondary_id

EU-99053

Identifier Type: -

Identifier Source: secondary_id

UKCCCR-QUASAR1

Identifier Type: -

Identifier Source: secondary_id

ISRCTN82375386

Identifier Type: -

Identifier Source: secondary_id

CDR0000067660

Identifier Type: -

Identifier Source: org_study_id