Study of S-1 and Oxaliplatin (SOX) Versus Capecitabine and Oxaliplatin (COX) in Patients With Advanced Colorectal Cancer

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 :

1. To evaluate and compare the efficacy (overall survival and response rate) in the two treatment groups.
2. To evaluate and compare the quality of life of the patients and safety profiles of the two treatment groups.

Conditions

• Colorectal Cancer

Interventions

DRUG

S-1 & Oxaliplatin

S-1 and Oxaliplatin : S-1 80 mg/m2/day, D1-14 Oxaliplatin, 130 mg/m2/day, D1 Repeated every 3 weeks

DRUG

Capecitabine & Oxaliplatin

COX : Capecitabine 1000 mg/m2/day, D1-14 Oxaliplatin, 130 mg/m2/day, D1 Repeated every 3 weeks

Sponsors & Collaborators

• National Cancer Center, Korea

  collaborator OTHER_GOV

• Seoul National University Bundang Hospital

  collaborator OTHER

• Seoul National University Hospital

  collaborator OTHER

• Gachon University Gil Medical Center

  collaborator OTHER

• Yonsei University

  collaborator OTHER

• Asan Medical Center

  collaborator OTHER

• Chonnam National University Hospital

  collaborator OTHER

• Samsung Medical Center

  lead OTHER

Principal Investigators

• Young Suk Park, M.D.,Ph.D. · Samsung Medical Center, Seoul, Korea

• Hye Jin Kang, M.D.,Ph.D. · Korea Cancer Center Hospital , Seoul, Korea

• Jee Hyun Kim, M.D.,Ph.D. · Seoul National University Bundang Hospital, Gyeonggi, Korea

• Tae Won Kim, M.D.,Ph.D. · Asan Medical Center, Seoul, Korea

• Tae-Yoo Kim, M.D.,Ph.D. · Seoul National University Hospital , Seoul, Korea

• Dong Bok Shin, M.D.,Ph.D. · Gil Medical Center, Gyeonggi, Korea

• Joong Bae Ahn, M.D.,Ph.D. · Yonsei Medical Center, Severance Hospital, Seoul, Korea

• Kyung Hee Lee, M.D.,Ph.D. · Yeungnam University College of Medicine , Daegu, Korea

• Namsu Lee, M.D.,Ph.D. · Soon Chun Hyang University Hospital , Seoul, Korea

• Ik-Joo Chung, M.D.,Ph.D. · Chonnam National University Hwasun Hospital, Jeollanamdo, Korea

• Yong Sang Hong, M.D.,Ph.D. · National Cancer Center, Gyeonggi, Korea

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-06-30

Primary Completion

2009-09-30

Completion

2011-01-31

Countries

• South Korea

Study Locations