Colorectal CancerPhase 3NCT00091312
Fluorouracil and Irinotecan With or Without Leucovorin Compared With Observation in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer
A Phase 3 study testing FOLFIRI regimen, fluorouracil and irinotecan hydrochloride in people with Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive at 9 sites in 6 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- FOLFIRI regimen, fluorouracil and irinotecan hydrochloride
- Type of treatment
- Surgery or procedure
- How many people
- 1,976 participants
- Where
- 9 sitesin 6 countries
- Study dates
- Jun 2004to 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the colon
- Stage II disease (pT3, N0 or pT4, N0)
- Penetration of the subserosa or serosa
- No lymph node metastases
- At least 12 lymph nodes analyzed
- More than 1 synchronous primary colon tumor allowed
- Staging determined for the more advanced tumor
- Curative radical resection within the past 2-8 weeks required
- Proximal, distal, and radical margins must be free of tumor (R0 resection)
- No rectal tumors
- Gross distal margin of the primary tumor must lie above the peritoneal reflection
- No known familial adenomatous polyposis
- No hereditary nonpolyposis colorectal cancer
- No distant metastases
PATIENT CHARACTERISTICS:
Age
- 18 to 75
Performance status
- WHO 0-1
Life expectancy
- Not specified
Hematopoietic
- Granulocyte count ≥ 2,000/mm^3
- Platelet count ≥ 100,000mm^3
- Hemoglobin ≥ 10 g/dL
Hepatic
- Bilirubin < 1.25 times upper limit of normal (ULN)
- No known Gilbert's syndrome
Renal
- Creatinine < 1.25 times ULN
Cardiovascular
- No severe or uncontrolled coronary disease
- No severe heart failure
- No uncontrolled arterial hypertension
- No myocardial infarction within the past year
- No cerebral vascular accident within the past year
- Cardiac arrhythmia allowed provided patient is on proper anticoagulation therapy* NOTE: *Aspirin is not considered proper anticoagulation
Gastrointestinal
- No Gardner's syndrome
- No Turcot's syndrome
- No Crohn's disease
- No ulcerative colitis
Other
- No other prior malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
- No other serious disease
- No contraindication to any study drugs
- No known allergy to leucovorin calcium
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for up to 6 months after study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy
Surgery
- See Disease Characteristics
Other
- No other concurrent anticancer therapy
- No concurrent vitamin supplements containing folic acid
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
Italy3 sites
Ospedali Riuniti di Bergamo
Bergamo, 24100
Azienda Ospedaliero Careggi
Florence, 50139
Universita Degli Studi di Florence - Policlinico di Careggi
Florence, 50139
France2 sites
Centre Hospitalier Universitaire Ambroise Pare - Boulogne
Boulogne-Billancourt, F-92104
Hopital Du Bocage
Dijon, 21034
Portugal1 site
Instituto Portugues de Oncologia Centro do Porto, S. A.
Porto, 4200-072
About this study
Official title: Randomized Phase III Intergroup Trial in Resected Stage 2 (Dukes B) Colon Cancer: 6-Month Infusional 5FU-CPT11 (+/- Folinic Acid) Versus Observation - Determination of Biologic Predictive and Response Factors
RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known whether combination chemotherapy is more effective than observation alone in treating patients who have undergone surgery for colon cancer.
PURPOSE: This randomized phase III trial is studying irinotecan and fluorouracil with or without leucovorin to see how well they work compared to observation alone in treating patients who have undergone surgery for stage II colon cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare 5-year disease-free survival in patients with resected stage II adenocarcinoma of the colon treated with adjuvant chemotherapy comprising fluorouracil and irinotecan with or without leucovorin calcium vs no adjuvant therapy.
Secondary
- Compare 8-year overall survival in patients treated with these regimens.
- Compare tolerability of these regimens in these patients.
- Correlate clinical, histological, and biological prognostic factors with outcome in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, disease stage (pT3 vs pT4), pathological differentiation (poorly or undifferentiated vs well or moderately differentiated), and microsatellite instability (positive vs negative vs unknown). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients are further randomized to receive 1 of 3 adjuvant chemotherapy regimens.
- Regimen A: Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1, 15, and 29. Treatment repeats every 42 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Regimen B: Patients receive irinotecan IV over 30-90 minutes followed by leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 24 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Regimen C: Patients receive irinotecan IV over 60 minutes followed by fluorouracil IV continuously over 48 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo observation only. Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 1,976 patients (988 per treatment arm [247 each in regimens A and B of arm I and 494 in regimen C of arm I]) will be accrued for this study within 4.5 years.
- Conditions
- Colorectal Cancer
- Being tested
- FOLFIRI regimen, fluorouracil, irinotecan hydrochloride, leucovorin calcium, adjuvant therapy
- Keywords
- stage II colon cancer, adenocarcinoma of the colon
- 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.
FOLFIRI regimenDrug
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 at 5 years
Secondary outcomes (3)
Overall survival at 8 years
Tolerability
Correlation of clinical, histological, and biological prognostic factors with outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2004 (estimated)
- Study startJun 2004
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
- 1,976 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Investigators
- Laurent Bedenne, MD, Study chair, Hopital Du Bocage
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091312
- Sponsor's protocol ID
- CDR0000387797
- Other IDs
- FFCD-EORTC-40012, EORTC-40012, PETACC-4
- Status last verified
- Dec 2006
- First submitted
- 7 Sep 2004
- Last updated
- 9 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Intergroup Trial in Resected Stage 2 (Dukes B) Colon Cancer: 6-Month Infusional 5FU-CPT11 (+/- Folinic Acid) Versus Observation - Determination of Biologic Predictive and Response Factors
- ClinicalTrials.gov ID
- NCT00091312
- Acronym / sponsor ID
- CDR0000387797
- Conditions
- Colorectal Cancer
- Keywords
- stage II colon cancer, adenocarcinoma of the colon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,976 participants (estimated)
- Lead sponsor
- Federation Francophone de Cancerologie DigestiveUniversity, hospital or other
- Study start
- Jun 2004
- First posted
- 9 Sep 2004 (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, such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known whether combination chemotherapy is more effective than observation alone in treating patients who have undergone surgery for colon cancer.
PURPOSE: This randomized phase III trial is studying irinotecan and fluorouracil with or without leucovorin to see how well they work compared to observation alone in treating patients who have undergone surgery for stage II colon cancer.
Detailed description
OBJECTIVES:
Primary
- Compare 5-year disease-free survival in patients with resected stage II adenocarcinoma of the colon treated with adjuvant chemotherapy comprising fluorouracil and irinotecan with or without leucovorin calcium vs no adjuvant therapy.
Secondary
- Compare 8-year overall survival in patients treated with these regimens.
- Compare tolerability of these regimens in these patients.
- Correlate clinical, histological, and biological prognostic factors with outcome in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, disease stage (pT3 vs pT4), pathological differentiation (poorly or undifferentiated vs well or moderately differentiated), and microsatellite instability (positive vs negative vs unknown). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients are further randomized to receive 1 of 3 adjuvant chemotherapy regimens.
- Regimen A: Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1, 15, and 29. Treatment repeats every 42 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Regimen B: Patients receive irinotecan IV over 30-90 minutes followed by leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 24 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Regimen C: Patients receive irinotecan IV over 60 minutes followed by fluorouracil IV continuously over 48 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo observation only. Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 1,976 patients (988 per treatment arm [247 each in regimens A and B of arm I and 494 in regimen C of arm I]) will be accrued for this study within 4.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 75 years
- 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 |
|---|---|---|
| FOLFIRI regimen | Drug | – |
| fluorouracil | Drug | – |
| irinotecan hydrochloride | Drug | – |
| leucovorin calcium | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
Primary outcome
Disease-free survival at 5 years
3 secondary outcomes
Overall survival at 8 years
Tolerability
Correlation of clinical, histological, and biological prognostic factors with outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2009.
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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.
Laurent Bedenne, MD study chair
Hopital Du Bocage
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FOLFIRI regimen, fluorouracil and irinotecan hydrochloride in people with Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive at 9 sites in 6 countries.
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 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, France, Egypt, Germany, Portugal and 1 more country. 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 at 5 years. 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 9 Feb 2009; AzTrials last refreshed its copy on 7 Nov 2026.