A Randomized Phase III Study of SOX vs. COX in Patients With Advanced Colorectal Cancer
Overview
- Phase
- Phase 3
- Intervention
- S-1 & Oxaliplatin
- Conditions
- Colorectal Cancer
- Sponsor
- Samsung Medical Center
- Enrollment
- 344
- Locations
- 11
- Primary Endpoint
- To compare the combination of S-1 and oxaliplatin to the combination of capecitabine and oxaliplatin in terms of progression free survival in patients previously untreated by systemic therapy for advanced or metastatic colorectal carcinoma.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
Primary objective :
To compare the combination of S-1 and oxaliplatin(SOX) to the combination of capecitabine and oxaliplatin(COX) therapy for advanced or metastatic colorectal carcinoma.
Secondary objectives :
- To evaluate and compare the efficacy (overall survival and response rate) in the two treatment groups.
- To evaluate and compare the quality of life of the patients and safety profiles of the two treatment groups.
Detailed Description
* The urgent need for new effective therapy with better safety profile for metastatic colorectal cancer patients and promising results observed so far in trials with S-1 combined with oxaliplatin in gastrointestinal cancer including colorectal cancer strongly warrants the comparison of S-1 combined with oxaliplatin to capecitabine combination with oxaliplatin acknowledged as a standard regimen in a first-line treatment for advanced colorectal cancer patients. * Recently, a Phase I study was completed, indicating recommended dose as S-1 100 mg/m2/day1-14 and oxaliplatin (130 mg/m2/day1), repeated every 3 weeks. However, in the phase II study using the above recommended dose, delayed toxicities of thrombocytopenia and anemia were observed. These delayed toxicities were also reported in a phase II study using S-1 90 mg/m2/day plus oxaliplatin 130 mg/m2/day1 in advanced gastric cancer. At 2007 GI ASCO, the interim data of S-1(80 mg/m2/day1-14) plus oxaliplatin (130 mg/m2/day1) combination, repeated every 3 weeks, was presented, showing promising antitumor activity with favourable safety profile. Among 18 patients, there were only two patients with Grade 3 thrombocytopenia and one with Grade 3 neutropenia. Response rate was 57.1 % and disease control rate was 92.9 %. Considering these results and Japanese data which showed that enhanced efficacy was not observed with S-1 over 90 mg/m2/day and oxaliplatin combination, S-1 80 mg/m2/day 1-14 and oxaliplatin 130 mg/m2/D1, repeated every 3 weeks, will be tested in this study.
Investigators
Young Suk Park
M.D.,Ph.D. Professor
Samsung Medical Center
Eligibility Criteria
Inclusion Criteria
- •Histologically documented colorectal adenocarcinoma
- •Age over 18 years old
- •Performance status (ECOG scale): 0-2
- •Measurable or evaluable disease
- •Patients can take food and drugs orally
- •Adequate organ functions
- •Life expectancy ≥ 3 months
- •Patients should sign a written informed consent before study entry
Exclusion Criteria
- •Tumor type other than adenocarcinoma
- •Second primary malignancy
- •Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) for advanced or metastatic colorectal cancer
- •Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease has been completed within 6 months prior to initiation of study treatment.
- •Prior radiotherapy was administered to target lesions selected for this study, or radiotherapy to the non-target lesions has been completed within 4 weeks before randomization.
- •Presence of CNS metastasis
- •Obvious peritoneal seeding or bowel obstruction disturbing oral intake
- •Symptomatic peripheral neuropathy
- •Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery. The patient received curative operation or RFA for metastatic disease.
- •Serious illness or medical conditions
Arms & Interventions
S-1 and Oxaliplatin
S-1 and Oxaliplatin S-1 : 80 mg/m2/day D1-14 Oxaliplatin : 130 mg/m2/day D1 Repeated every 3 weeks
Intervention: S-1 & Oxaliplatin
Capecitabine and Oxaliplatin
Capecitabine and Oxaliplatin
Intervention: Capecitabine & Oxaliplatin
Outcomes
Primary Outcomes
To compare the combination of S-1 and oxaliplatin to the combination of capecitabine and oxaliplatin in terms of progression free survival in patients previously untreated by systemic therapy for advanced or metastatic colorectal carcinoma.
Time Frame: 9 months
Secondary Outcomes
- To evaluate and compare the efficacy (overall survival and response rate) in the two treatment groups.(24 months)
- To evaluate and compare the quality of life of the patients and safety profiles of the two treatment groups.(24 months)