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History of Changes for Study: NCT01308086
Adjuvant Therapy(3 vs. 6 Months) With the FOLFOX 4 or XELOX for Stage II or Stage III Colon Cancer
Latest version (submitted August 8, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 2, 2011 None (earliest Version on record)
2 June 26, 2012 Sponsor/Collaborators, Study Status and Conditions
3 October 25, 2012 Study Status
4 May 9, 2013 Study Status
5 November 15, 2013 Study Status
6 June 21, 2014 Study Status
7 September 25, 2015 Study Status
8 September 21, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
9 October 11, 2016 Study Status
10 February 22, 2017 Study Status
11 August 8, 2017 Recruitment Status and Study Status
Comparison Format:
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Study NCT01308086
Submitted Date:  March 2, 2011 (v1)
Open or close this module Study Identification
Unique Protocol ID: CT/09.12
Brief Title: Adjuvant Therapy(3 vs. 6 Months) With the FOLFOX 4 or XELOX for Stage II or Stage III Colon Cancer
Official Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2011
Overall Status: Recruiting
Study Start: October 2010
Primary Completion: September 2013 [Anticipated]
Study Completion: September 2013 [Anticipated]
First Submitted: March 1, 2011
First Submitted that
Met QC Criteria:		 March 2, 2011
First Posted: March 3, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:		 March 2, 2011
Last Update Posted: March 3, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Hellenic Oncology Research Group
Responsible Party:
Collaborators: University Hospital of Crete
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief 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.
Detailed Description:

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.
Open or close this module Conditions
Conditions: Carcinoma of the Large Intestine
Keywords: Cancer
colorectal cancer
adjuvant chemotherapy
capecitabine
oxaliplatin
5 fluorouracil
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 2000 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: FOLFOX 4 - 6months or XELOX -6months Drug: 5-Fluorouracil
5-FU 400mg/m2 Bolus and then 22 hours 5-FU 600mg/m2 IV, days 1 & 2, q2w, for 12 cycles
Other Names:
  • 5-FU
Drug: Leucovorin
Leucovorin 200mg/m2 IV in 2 hours, days 1 & 2, q2w, for 12 cycles
Drug: Oxaliplatin
Oxaliplatin 85mg/m2 in 2 hours IV, day 1, q2w, for 12 cycles
Other Names:
  • LoHP
Drug: Capecitabine
Capecitabine 1000 mg/m2 X 2 ,days 1-14, q2w, for 8 cycles
Other Names:
  • Xeloda
Drug: Oxaliplatin
Oxaliplatin 130 mg/m2 in 2 hours IV, day 1, q2w, for 8 cycles
Other Names:
  • LoHP
Experimental: FOLFOX4 -3months or XELOX -3months Drug: 5-Fluorouracil
5-FU 400mg/m2 Bolus and then 22 hours 5-FU 600mg/m2 IV, days 1 & 2, q2w, for 6 cycles
Other Names:
  • 5-FU
Drug: Leucovorin
Leucovorin 200mg/m2 IV in 2 hours, days 1 & 2, q2w, for 6 cycles
Drug: Capecitabine
Capecitabine 1000 mg/m2 X 2 ,days 1-14, q2w, for 4 cycles
Other Names:
  • Xeloda
Drug: Oxaliplatin
Oxaliplatin 130 mg/m2 in 2 hours IV, day 1, q2w, for 4 cycles
Other Names:
  • LoHP
Drug: Oxaliplatin
Oxaliplatin 85mg/m2 in 2 hours IV, day 1, q2w, for 6 cycles
Other Names:
  • LoHP
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Relapse Free Survival
[ Time Frame: 3-years ]
Secondary Outcome Measures:
1. Overall Survival
[ Time Frame: 3-years ]
2. Safety Profil according to NCI-CTAE v 3.0
[ Time Frame: q2w ]

Percentage (%) of treatments delays and interaptions in each arm Percentage (%) of dose received versus planned dose in each arm
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Dora Hatzidaki
Telephone: +302810392570
Email: dorachat@med.uoc.gr
Central Contact Backup: Ioannis Athanassakis
Telephone: +302810392783
Email: dclintrials@gmail.com
Study Officials: John Souglakos, MD
Principal Investigator
University Hospital of Crete, Dep of Medical Oncology
Vassilis Georgoulias, MD
Study Chair
University Hospital of Crete, Dep of Medical Oncology
Locations: Greece
University Hospital of Crete, Dep of Medical Oncology
[Recruiting]
Heraklion, Greece
Contact:Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr
Contact:Contact: Ioannis Athanasakis +302810392783 dclintrials@gmail.com
Contact:Principal Investigator: John Souglakos, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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