Colorectal CancerPhase 3NCT00046995
Combination Chemotherapy in Treating Patients With Colon Cancer
A Phase 3 study testing carboplatin, fluorouracil and leucovorin calcium in people with Colorectal Cancer, run by Groupe Regional d'Etudes du Cancer Colorectal at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- carboplatin, fluorouracil and leucovorin calcium
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 2 sitesBelgium
- Study dates
- May 2001to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Centre Hospitalier Hutois
Huy, 4500
Clinique Saint-Joseph
Liège, B 4000
About this study
Official title: 5-Fluorouracil-Leucovorin With or Without Carboplatin as Adjuvant Treatment for Primary Dukes B2-C Colon Cancer; Chronomodulated Versus Standard Administration. A Multicenter Randomized Phase III Trial of the GRECCR-Belgium (Study 03).
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.
Read the detailed description
OBJECTIVES:
- 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
- Colorectal Cancer
- Being tested
- carboplatin, fluorouracil, leucovorin calcium, adjuvant therapy
- Keywords
- adenocarcinoma of the colon, stage IIB colon cancer, stage IIIA colon cancer, stage IIIB colon cancer, stage IIIC colon cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
fluorouracilDrug
adjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Secondary outcomes (2)
Tolerability
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMay 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Regional d'Etudes du Cancer Colorectal
- Sponsor type
- University, hospital or other
- Investigators
- Christian N.J. Focan, MD, PhD, Study chair, Clinique Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046995
- Sponsor's protocol ID
- CDR0000257228
- Other IDs
- GRECCR-03, EU-20201
- Status last verified
- Nov 2002
- First submitted
- 3 Oct 2002
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5-Fluorouracil-Leucovorin With or Without Carboplatin as Adjuvant Treatment for Primary Dukes B2-C Colon Cancer; Chronomodulated Versus Standard Administration. A Multicenter Randomized Phase III Trial of the GRECCR-Belgium (Study 03).
- ClinicalTrials.gov ID
- NCT00046995
- Acronym / sponsor ID
- CDR0000257228
- Conditions
- Colorectal Cancer
- Keywords
- adenocarcinoma of the colon, stage IIB colon cancer, stage IIIA colon cancer, stage IIIB colon cancer, stage IIIC colon cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Groupe Regional d'Etudes du Cancer ColorectalUniversity, hospital or other
- Study start
- May 2001
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboplatin | Drug | – |
| fluorouracil | Drug | – |
| leucovorin calcium | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
Primary outcome
Disease-free survival
2 secondary outcomes
Tolerability
Quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian N.J. Focan, MD, PhD study chair
Clinique Saint-Joseph
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing carboplatin, fluorouracil and leucovorin calcium in people with Colorectal Cancer, run by Groupe Regional d'Etudes du Cancer Colorectal at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.