NCT00046995

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which schedule of chemotherapy is most effective in treating colon cancer. PURPOSE: Randomized phase III trial to compare different schedules of chemotherapy using carboplatin with fluorouracil and leucovorin in treating patients who have stage IIB or stage III colon cancer.

Trial Health

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Trial Health Score

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

Enrollment
800

participants targeted

Target at P50-P75 for phase_3 colorectal-cancer

Geographic Reach
1 country

2 active sites

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

May 1, 2001

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2002

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

September 20, 2013

Status Verified

November 1, 2002

First QC Date

October 3, 2002

Last Update Submit

September 19, 2013

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the colonstage IIB colon cancerstage IIIA colon cancerstage IIIB colon cancerstage IIIC colon cancer

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

Secondary Outcomes (2)

  • Tolerability

  • Quality of life

Interventions

carboplatinDRUG
fluorouracilDRUG
leucovorin calciumDRUG
adjuvant therapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon * Stage IIB or III (Dukes stage B2 or C) * Complete curative resection performed within the past 7 weeks (negative margins) * No local or regional relapsed disease * Tumor more than 15 cm above the anal margin * Carcinoembryonic antigen less than 5 ng/mL (after surgery) * No rectal cancer * No metastatic disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 OR * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Neutrophil count at least 2,000/mm3 * Platelet count at least 100,000/mm3 Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT and SGPT no greater than 5 times ULN Renal * Creatinine no greater than 1.5 times ULN Cardiovascular * No serious coronary disease Other * Not pregnant * Fertile patients must use effective contraception * No concurrent infectious disease * No other malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy (before or after surgery) Surgery * See Disease Characteristics Other * No concurrent participation in another clinical trial

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

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Hutois

Huy, 4500, Belgium

Location

Clinique Saint-Joseph

Liège, B 4000, Belgium

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Neoplasms

Interventions

CarboplatinFluorouracilLeucovorinChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Christian N.J. Focan, MD, PhD

    Clinique Saint-Joseph

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

October 3, 2002

First Posted

January 27, 2003

Study Start

May 1, 2001

Last Updated

September 20, 2013

Record last verified: 2002-11

Locations

BE(2)