Adjuvant Therapy(3 vs. 6 Months) With the FOLFOX 4 or XELOX for Stage II or Stage III Colon Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
CRC |
Drug: 5-Fluorouracil Drug: Leucovorin Drug: Oxaliplatin Drug: Capecitabine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Relapse Free Survival [ Time Frame: 3-years ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 3-years ] [ Designated as safety issue: No ]
- Safety Profil according to NCI-CTAE v 3.0 [ Time Frame: q2w ] [ Designated as safety issue: Yes ]Percentage (%) of treatments delays and interaptions in each arm Percentage (%) of dose received versus planned dose in each arm
| Estimated Enrollment: | 2000 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| 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 Name: 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 Name: LoHP
Drug: Capecitabine
Capecitabine 1000 mg/m2 X 2 ,days 1-14, q2w, for 8 cycles
Other Name: Xeloda
Drug: Oxaliplatin
Oxaliplatin 130 mg/m2 in 2 hours IV, day 1, q2w, for 8 cycles
Other Name: 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 Name: 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 Name: Xeloda
Drug: Oxaliplatin
Oxaliplatin 130 mg/m2 in 2 hours IV, day 1, q2w, for 4 cycles
Other Name: LoHP
Drug: Oxaliplatin
Oxaliplatin 85mg/m2 in 2 hours IV, day 1, q2w, for 6 cycles
Other Name: LoHP
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Dora Hatzidaki | +302810392570 | dorachat@med.uoc.gr |
| Contact: Ioannis Athanassakis | +302810392783 | dclintrials@gmail.com |
| Greece | |
| University Hospital of Crete, Dep of Medical Oncology | Recruiting |
| Heraklion, Greece | |
| Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr | |
| Contact: Ioannis Athanasakis +302810392783 dclintrials@gmail.com | |
| Principal Investigator: John Souglakos, MD | |
| Principal Investigator: | John Souglakos, MD | University Hospital of Crete, Dep of Medical Oncology |
| Study Chair: | Vassilis Georgoulias, MD | University Hospital of Crete, Dep of Medical Oncology |
More Information
No publications provided
| Responsible Party: | Hellenic Oncology Research Group |
| ClinicalTrials.gov Identifier: | NCT01308086 History of Changes |
| Other Study ID Numbers: | CT/09.12 |
| Study First Received: | March 1, 2011 |
| Last Updated: | May 9, 2013 |
| Health Authority: | Greece: National Organization of Medicines |
Keywords provided by Hellenic Oncology Research Group:
|
Cancer colorectal cancer adjuvant chemotherapy |
capecitabine oxaliplatin 5 fluorouracil |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Adjuvants, Immunologic Fluorouracil Capecitabine Oxaliplatin |
Leucovorin Levoleucovorin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Vitamin B Complex Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013