Status:
COMPLETED
Study of S-1 and Oxaliplatin (SOX) Versus Capecitabine and Oxaliplatin (COX) in Patients With Advanced Colorectal Cancer
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
National Cancer Center, Korea
Seoul National University Bundang Hospital
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 g...
Eligibility Criteria
Inclusion
- 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
- 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
- Receiving a concomitant treatment with drugs interacting with S-1, capecitabine or oxaliplatin, as follows;flucytosine, a fluorinated pyrimidine antifungal agent phenytoin warfarin etc.
- Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug.
- Pregnant or lactating woman
- Women of child bearing potential not using a contraceptive method
- Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
- Any patients judged by the investigator to be unfit to participate in the study
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT00677443
Start Date
June 1 2008
End Date
January 1 2011
Last Update
June 14 2013
Active Locations (11)
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1
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 410-769
2
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
3
Chonnam National University Hospital
Hwasun, Jeollanamdo, South Korea, 519-809
4
Yeungnam University
Daegu, South Korea, 705-717