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

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ClinicalTrials.gov Identifier: NCT00677443
Recruitment Status : Completed
First Posted : May 14, 2008
Last Update Posted : June 14, 2013
Sponsor:
Collaborators:
National Cancer Center, Korea
Seoul National University Bundang Hospital
Seoul National University Hospital
Gachon University Gil Medical Center
Yonsei University
Asan Medical Center
Chonnam National University Hospital
Information provided by (Responsible Party):
Young Suk Park, Samsung Medical Center

Study Description
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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 :

  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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: S-1 & Oxaliplatin Drug: Capecitabine & Oxaliplatin Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 344 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study of SOX vs. COX in Patients With Advanced Colorectal Cancer
Study Start Date : June 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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

 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
Other Name: S-1 and Oxaliplatin
Active Comparator: Capecitabine and Oxaliplatin
Capecitabine and Oxaliplatin
 Drug: Capecitabine & Oxaliplatin
COX : Capecitabine 1000 mg/m2/day, D1-14 Oxaliplatin, 130 mg/m2/day, D1 Repeated every 3 weeks
Other Name: Capecitabine and Oxaliplatin


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. To evaluate and compare the efficacy (overall survival and response rate) in the two treatment groups. [ Time Frame: 24 months ]
  2. To evaluate and compare the quality of life of the patients and safety profiles of the two treatment groups. [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00677443


Locations
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Korea, Republic of
National Cancer Center
Goyang, Gyeonggi, Korea, Republic of, 410-769
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of
Chonnam National University Hospital
Hwasun, Jeollanamdo, Korea, Republic of, 519-809
Yeungnam University
Daegu, Korea, Republic of, 705-717
Gachon University Gil Medical Center
Inchon, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Korea Cancer Center Hospital
Seoul, Korea, Republic of, 139-706
Soon Chun Hyang University Hospital
Seoul, Korea, Republic of, 140-743
Seoul National University Hospital
Seoul, Korea, Republic of
Yonsei University
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
National Cancer Center, Korea
Seoul National University Bundang Hospital
Seoul National University Hospital
Gachon University Gil Medical Center
Yonsei University
Asan Medical Center
Chonnam National University Hospital
Investigators
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Study Chair: Young Suk Park, M.D.,Ph.D. Samsung Medical Center, Seoul, Korea
Principal Investigator: Hye Jin Kang, M.D.,Ph.D. Korea Cancer Center Hospital , Seoul, Korea
Principal Investigator: Jee Hyun Kim, M.D.,Ph.D. Seoul National University Bundang Hospital, Gyeonggi, Korea
Principal Investigator: Tae Won Kim, M.D.,Ph.D. Asan Medical Center, Seoul, Korea
Principal Investigator: Tae-Yoo Kim, M.D.,Ph.D. Seoul National University Hospital , Seoul, Korea
Principal Investigator: Dong Bok Shin, M.D.,Ph.D. Gil Medical Center, Gyeonggi, Korea
Principal Investigator: Joong Bae Ahn, M.D.,Ph.D. Yonsei Medical Center, Severance Hospital, Seoul, Korea
Principal Investigator: Kyung Hee Lee, M.D.,Ph.D. Yeungnam University College of Medicine , Daegu, Korea
Principal Investigator: Namsu Lee, M.D.,Ph.D. Soon Chun Hyang University Hospital , Seoul, Korea
Principal Investigator: Ik-Joo Chung, M.D.,Ph.D. Chonnam National University Hwasun Hospital, Jeollanamdo, Korea
Principal Investigator: Yong Sang Hong, M.D.,Ph.D. National Cancer Center, Gyeonggi, Korea
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Young Suk Park, M.D.,Ph.D. Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00677443    
Other Study ID Numbers: 2008-03-012
First Posted: May 14, 2008    Key Record Dates
Last Update Posted: June 14, 2013
Last Verified: June 2013
Keywords provided by Young Suk Park, Samsung Medical Center:
metastatic colorectal cancer
S-1
Capecitabine
Oxaliplatin
non-inferiority study
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Intestinal Diseases
Rectal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents