NCT00002692

Brief 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. PURPOSE: Randomized phase III trial to compare the effectiveness of intravenous infusion or intrahepatic infusion of fluorouracil and leucovorin in treating patients with colorectal cancer metastatic to the liver.

Trial Health

55
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Trial Health Score

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

Enrollment
312

participants targeted

Target at P25-P50 for phase_3 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1994

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.6 years until next milestone

First Posted

Study publicly available on registry

May 21, 2004

Completed
Last Updated

December 19, 2013

Status Verified

May 1, 2007

First QC Date

November 1, 1999

Last Update Submit

December 18, 2013

Conditions

Colorectal CancerMetastatic Cancer

Keywords

stage IV colon cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal canceradenocarcinoma of the colonadenocarcinoma of the rectumliver metastases

Interventions

fluorouracilDRUG
isolated perfusionDRUG
leucovorin calciumDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon or rectum with metastases confined to the liver and not amenable to surgery PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 3.5 mg/dL (50 micromoles/liter) Renal: Not specified Cardiovascular: No uncontrolled heart disease (e.g., congestive heart failure, angina) Other: No uncontrolled infection No other uncontrolled medical illness PRIOR CONCURRENT THERAPY: No prior fluorouracil (5-FU) for advanced disease More than 6 months since adjuvant 5-FU (e.g., in AXIS or QUASAR studies)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University Birmingham

Birmingham, England, B15 2TT, United Kingdom

Location

Related Publications (3)

  • McArdle C: IV versus IHA 5FU/leucovorin for colorectal liver metastases: preliminary results of the MRC CR05 EORTC 40972 randomised trial. [Abstract] Br J Cancer 85 (suppl 1): A-CT2. 1, 2001.

    RESULT

  • McArdle C, Kerr DJ, Ledermann J, et al.: Intravenous (IV) vs intrahepatic (IHA) 5FU/leucovorin for colorectal (CRC) liver metastases: preliminary results of the MRC CR05/EORTC 40972 randomised trial. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-499, 2001.

    RESULT

  • McArdle C, Kerr DJ, Ledermann J, et al.: Intravenous (IV) vs intrahepatic arterial (IHA) 5-FU/leucovorin for colorectal (CRC) liver metastasis: preliminary results of the MRC CRO5/EORTC 40972 randomised trial. [Abstract] Eur J Cancer 37 (suppl 6): A-955, s257, 2001.

    RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm MetastasisColonic NeoplasmsRectal Neoplasms

Interventions

FluorouracilLeucovorin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • David J. Kerr, MD, FRCP, DSc

    University Hospital Birmingham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 21, 2004

Study Start

December 1, 1994

Last Updated

December 19, 2013

Record last verified: 2007-05

Locations

GB(1)