Status:
COMPLETED
FOLFOX-4 3months Versus 6 Months and Bevacizumab as Adjuvant Therapy for Patients With Stage II/III Colon Cancer
Lead Sponsor:
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Collaborating Sponsors:
Mario Negri Institute for Pharmacological Research
Conditions:
Colon Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This project consists of two independent, following specific eligibility criteria and different randomisation schemes studies, later on called DURATION study and BEV study. Once randomised in the dura...
Detailed Description
At the present time the standard treatment for resected colon cancer with high possibility of relapse ("high risk" stage II and all stage III) is represented by the regimen FOLFOX (leucovorin, bolus a...
Eligibility Criteria
Inclusion
- Histologically confirmed AJCC/UICC high-risk stage II or stage III colon cancer . High-risk stage III patients (T4, N+, M0, or any T, N2, M0) may also be further randomized in the BEV study (plus or minus BEV)
- Stage II patients have to be considered at high-risk if they fulfill \>1 of the following criteria:
- T4 tumours,
- grade \>3,
- clinical presentation with bowel obstruction or perforation,
- histological signs of vascular or lymphatic or perineural invasion,
- \<12 nodes examined
- Age 18 to 75 years
- Curative surgery no less than 3 ( 4 in the BEV study) and no more than 8 weeks prior to randomization
- ECOG performance Status (ECOG-PS) \<1
- Signed written informed consent obtained prior to any study specific procedures
Exclusion
- Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections).
- Previous anti-angiogenic treatment for any malignancy; cytotoxic chemotherapy, radiotherapy or immunotherapy for colon cancer
- Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)
- Lactating women
- Fertile women (\<2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception
- History of clinically relevant psychiatric disability , precluding informed consent
- Clinically relevant cardiovascular disease
- History or presence of other diseases
- Evidence of bleeding diathesis or coagulopathy
- Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes
- Chronic, daily treatment with high-dose aspirin (\>325 mg/day) or clopidogrel (\>75 mg/day)
- Current or recent (within the 28 days prior to randomization) treatment with another investigational drug or participation in another investigational study
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
3756 Patients enrolled
Trial Details
Trial ID
NCT00646607
Start Date
June 1 2007
End Date
November 1 2014
Last Update
November 26 2014
Active Locations (111)
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1
Ospedale Santo Spirito
Casale Monferrato, AL, Italy, 15033
2
A.O. Umberto I -Università Località Torrette
Ancona, AN, Italy, 62020
3
Ospedale Profili
Fabriano, AN, Italy, 60044
4
Ospedale Mazzoni
Ascoli Piceno, AP, Italy, 63100