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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00677443
First received: May 12, 2008
Last updated: June 12, 2013
Last verified: June 2013

May 12, 2008
June 12, 2013
June 2008
September 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00677443 on ClinicalTrials.gov Archive Site
  • To evaluate and compare the efficacy (overall survival and response rate) in the two treatment groups. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • To evaluate and compare the quality of life of the patients and safety profiles of the two treatment groups. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of S-1 and Oxaliplatin (SOX) Versus Capecitabine and Oxaliplatin (COX) in Patients With Advanced Colorectal Cancer
A Randomized Phase III Study of SOX vs. COX in Patients With Advanced Colorectal Cancer

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.
  • 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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • 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
  • 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
  • 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

    Intervention: Drug: S-1 & Oxaliplatin
  • Active Comparator: Capecitabine and Oxaliplatin
    Capecitabine and Oxaliplatin
    Intervention: Drug: Capecitabine & Oxaliplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
344
January 2011
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00677443
2008-03-012
No
Young Suk Park, Samsung Medical Center
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
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
Samsung Medical Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP