Overview

Adjuvant Therapy(3 vs. 6 Months) With the FOLFOX 4 or XELOX for Stage II or Stage III Colon Cancer

Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare whether a 3-month treatment is at least not inferior to a 6-month treatment (FOLFOX-4 6 vs. 12 cycles or XELOX 4 cycles vs. 8 cycles) in terms of RFS in patients with high risk stage II or stage III radically resected colon cancer.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hellenic Oncology Research Group
Collaborator:
University Hospital of Crete
Treatments:
Capecitabine
Fluorouracil
Leucovorin
Levoleucovorin
Oxaliplatin
Criteria
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