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A Multicenter Trial Investigating the Duration of Adjuvant Therapy(3 vs. 6 Months) With the FOLFOX 4 or XELOX Regimen for Patients With High Risk Stage II or Stage III Colon Cancer

Phase 3
18 Years
Open (Enrolling)

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Trial Information

A Multicenter Trial Investigating the Duration of Adjuvant Therapy(3 vs. 6 Months) With the FOLFOX 4 or XELOX Regimen for Patients With High Risk Stage II or Stage III Colon Cancer

Six months of adjuvant chemotherapy with 5-FU and oxaliplatin for patients with stage III
colon cancer is the world-wide standard of care, based on the MOSAIC and C-07 trials.
However, it leads to significant cost, toxicity, and inconvenience. In particular, the onset
of oxaliplatin induced cumulative dose-dependent neuropathies is a significant issue. The
ability to maintain efficacy with a reduced duration of therapy would have clear advantage
to patients, to providers, and to the health care system.

Multiple large trials in the 1990s demonstrated that the previous standard of 12 months of
therapy could be reduced to 6 months. A single small trial with 5-FU alone demonstrated
similar outcomes for 3 versus 6 months of therapy. Thus, it is proposed to definitively
evaluate the non-inferiority of 3 months of oxaliplatin-based adjuvant chemotherapy versus
the current standard of 6 months. The primary endpoint will be disease-free survival (DFS).

It is essential to have sufficient power to eliminate the possibility of clinically
meaningful inferiority of 3 months of therapy: a huge number of patients will be necessary.
Previous efforts and experience have conclusively demonstrated that in colon cancer, a
single, global trial is impractical. Consequently, an international, prospective pooled
analysis will be performed, gathering data of independent trials run in different countries,
to answer the single primary hypothesis that 3 months of adjuvant therapy with FOLFOX/XELOX
is non-inferior to the current standard of 6 months. Among six planned countries, the Greek
intergroup will conduct one of these trials.

Inclusion Criteria:

- Histologically- - confirmed adenocarcinoma of the colon or rectum stage III or stage
with at least one of the follow characteristics T4 tumours, undifferentiated tumor
grade >3, bowel obstruction or perforation, vascular or lymphatic or perineural
invasion, <12 nodes examined, Stage IV.

- Signed written informed consent

- Randomization between 2 -8 weeks after curative surgery

- Age >18 years

- ECOG performance Status 0-1

- Pretreatment CEA within UNL

- Post-menopausal women or women willing to accept the use of an effective
contraception. Pre-menopausal women should have a negative pregnancy test within 72
hours prior to randomization

- Men should also accept to use an effective contraception

- R0 resections

Exclusion Criteria:

- Evidence of metastatic disease (including presence of tumor cells in ascites or
peritoneal carcinomatosis resected "en bloc")

- Evidence of 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)

- No pregnant or lactating women

- Presence of clinically relevant cardiovascular disease

- Presenc of medical history or current evidence of CNS disease

- Presence of peripheral neuropathy ≤ grade 1 (CTCAE v. 3.0)

- History of clinically relevant psychiatric disability, precluding informed consent

Type of Study:


Study Design:

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

Outcome Measure:

Relapse Free Survival

Outcome Time Frame:


Safety Issue:


Principal Investigator

John Souglakos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete, Dep of Medical Oncology


Greece: National Organization of Medicines

Study ID:




Start Date:

October 2010

Completion Date:

September 2013

Related Keywords:

  • CRC
  • Cancer
  • colorectal cancer
  • adjuvant chemotherapy
  • capecitabine
  • oxaliplatin
  • 5 fluorouracil
  • Colonic Neoplasms