Clinical trial · Interventional
FOLFOX-4 3months Versus 6 Months and Bevacizumab as Adjuvant Therapy for Patients With Stage II/III Colon Cancer
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
NCT00646607CI-TRIAL-00016157TOSCAcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin) | Drug | FOLFOX Regimen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- FOLFOX-4 (infusional 5-Fluouracil, leucovorin and oxaliplatin) for 3 months or XELOX (capecitabine and oxaliplatin) for 12 weeks.
- interventionNames
- Drug: FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- FOLFOX-4 (infusional 5-Fluouracil, leucovorin and oxaliplatin) for 6 months or XELOX (capecitabine and oxaliplatin) for 24 weeks.
- interventionNames
- Drug: FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)
Primary outcomes (1)
- measure
- disease free survival (DFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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) * 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
References
Publications (1)
pubmedProvenance
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Silvia Marsoni, Clara Montagut, Filippo Pietrantonio et al. · Nat Cancer · Sep 14, 2026 · PMID 42736431 pubmed
- DERIVEDGallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28. PMID 36306483
- DERIVEDIveson TJ, Sobrero AF, Yoshino T, Souglakos I, Ou FS, Meyers JP, Shi Q, Grothey A, Saunders MP, Labianca R, Yamanaka T, Boukovinas I, Hollander NH, Galli F, Yamazaki K, Georgoulias V, Kerr R, Oki E, Lonardi S, Harkin A, Rosati G, Paul J. Duration of Adjuvant Doublet Chemotherapy (3 or 6 months) in Patients With High-Risk Stage II Colorectal Cancer. J Clin Oncol. 2021 Feb 20;39(6):631-641. doi: 10.1200/JCO.20.01330. Epub 2021 Jan 13.