Combination Chemotherapy in Treating Patients With Colon Cancer
NCT ID: NCT00046995
Last Updated: 2013-09-20
Study Results
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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UNKNOWN
PHASE3
800 participants
INTERVENTIONAL
2001-05-31
Brief Summary
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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.
Detailed Description
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* Compare the disease-free survival of patients with completely resected stage IIB or III colon cancer treated with adjuvant chronomodulated vs standard schedule fluorouracil and leucovorin calcium with or without carboplatin.
* Compare the overall survival of patients treated with these regimens.
* Compare the toxicity of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
* Determine the dose intensities of fluorouracil and carboplatin in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and disease stage (IIB vs III). Patients are randomized to 1 of 4 treatment arms.
* Arm I (standard schedule): Patients receive fluorouracil (5-FU) IV continuously and leucovorin calcium (CF) IV on days 1 and 2.
* Arm II (standard + carboplatin schedule): Patients receive 5-FU and CF as in arm I plus carboplatin IV on day 1.
* Arm III (chronomodulated schedule): Patients receive 5-FU IV continuously and CF IV continuously on days 1-4.
* Arm IV (chronomodulated + carboplatin schedule): Patients receive 5-FU and CF as in arm III plus carboplatin IV continuously on days 1-4.
Quality of life is assessed.
Treatment in all arms repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 660-800 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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carboplatin
fluorouracil
leucovorin calcium
adjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Groupe Regional d'Etudes du Cancer Colorectal
OTHER
Principal Investigators
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Christian N.J. Focan, MD, PhD
Role: STUDY_CHAIR
Clinique Saint-Joseph
Locations
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Centre Hospitalier Hutois
Huy, , Belgium
Clinique Saint-Joseph
Liège, , Belgium
Countries
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Other Identifiers
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GRECCR-03
Identifier Type: -
Identifier Source: secondary_id
EU-20201
Identifier Type: -
Identifier Source: secondary_id
CDR0000257228
Identifier Type: -
Identifier Source: org_study_id