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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

Phase 3
18 Years
75 Years
Open (Enrolling)
Colon Cancer

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Trial Information

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

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 and infusional 5fluorouracil and oxaliplatin), which is able to increase
significantly the disease-free survival (DFS) at 3 and 4 years, whereas the advantage for
5-year overall survival (OS) (which is predicted by the previous parameter) could be
observed only with a further increase of follow-up. The conventional duration of
chemotherapy is today of 6 months (12 courses every 2 weeks), but this long drug exposure
increases the risk of long-term neurotoxicity. A reduction of adjuvant chemotherapy under 6
months was proven effective in other cancers (breast, testis…) and is better tolerated by
patients in clinical practice. On the other hand, bevacizumab significantly increases OS and
all other parameters when combined with standard chemotherapy in advanced disease.

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

- Current or recent (within the 28 days prior to randomization) treatment with another
investigational drug or participation in another investigational study

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease free survival (DFS)

Outcome Time Frame:

time from randomization date to date of local or regional relapse

Safety Issue:


Principal Investigator

Roberto Labianca, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente


Italy: The Italian Medicines Agency

Study ID:




Start Date:

June 2007

Completion Date:

Related Keywords:

  • Colon Cancer
  • colorectal neoplasm
  • high risk
  • stage II/III
  • Colonic Neoplasms