FOLFOX-4 3months Versus 6 Months and Bevacizumab as Adjuvant Therapy for Patients With Stage II/III Colon Cancer (TOSCA)
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ClinicalTrials.gov Identifier: NCT00646607 |
Recruitment Status :
Completed
First Posted : March 28, 2008
Last Update Posted : November 26, 2014
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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 duration study, patients fulfilling eligibility criteria for BEV study may also be randomized to receive BEV or no BEV, in addition to FOLFOX-4 chemotherapy.
As both are open label studies, there will be no blinding of treatment assignment.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colon Cancer | Drug: FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3756 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Trial Investigating the Role of FOLFOX-4 Regimen Duration (3 Versus 6 Months) and Bevacizumab as Adjuvant Therapy for Patients With Stage II/III Colon Cancer |
Study Start Date : | June 2007 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | November 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: A
FOLFOX-4 (infusional 5-Fluouracil, leucovorin and oxaliplatin) for 3 months or XELOX (capecitabine and oxaliplatin) for 12 weeks.
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Drug: FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)
To assess whether a 3-month FOLFOX-4 treatment is at least equivalent to a 6-month FOLFOX-4 treatment
Other Name: FOLFOX 3 vs 6 |
Active Comparator: B
FOLFOX-4 (infusional 5-Fluouracil, leucovorin and oxaliplatin) for 6 months or XELOX (capecitabine and oxaliplatin) for 24 weeks.
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Drug: FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)
standard treatment
Other Name: FOLFOX 3 vs 6 |
- disease free survival (DFS) [ Time Frame: time from randomization date to date of local or regional relapse ]
- overall Survival (OS), Toxicity and incidence of adverse events [ Time Frame: from the day of randomisation to the date of death from any cause. ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
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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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00646607

Principal Investigator: | Roberto Labianca, MD | Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente | |
Study Chair: | Alberto Sobrero, MD | Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente |
Responsible Party: | Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente |
ClinicalTrials.gov Identifier: | NCT00646607 |
Other Study ID Numbers: |
2007-000354-31 |
First Posted: | March 28, 2008 Key Record Dates |
Last Update Posted: | November 26, 2014 |
Last Verified: | December 2009 |
colorectal neoplasm high risk stage II/III |
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Leucovorin Fluorouracil Oxaliplatin |
Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antidotes Protective Agents Vitamin B Complex Vitamins Micronutrients |