Study of S-1 and Oxaliplatin (SOX) Versus Capecitabine and Oxaliplatin (COX) in Patients With Advanced Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
S-1 & Oxaliplatin
Capecitabine & Oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring metastatic colorectal cancer, S-1, Capecitabine, Oxaliplatin, non-inferiority study
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
- 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
Sites / Locations
- National Cancer Center
- Seoul National University Bundang Hospital
- Chonnam National University Hospital
- Yeungnam University
- Gachon University Gil Medical Center
- Samsung Medical Center
- Asan Medical Center
- Korea Cancer Center Hospital
- Soon Chun Hyang University Hospital
- Seoul National University Hospital
- Yonsei University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
S-1 and Oxaliplatin
Capecitabine and Oxaliplatin
Arm Description
S-1 and Oxaliplatin S-1 : 80 mg/m2/day D1-14 Oxaliplatin : 130 mg/m2/day D1 Repeated every 3 weeks
Capecitabine and Oxaliplatin
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00677443
First Posted
May 12, 2008
Last Updated
June 12, 2013
Sponsor
Samsung Medical Center
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
1. Study Identification
Unique Protocol Identification Number
NCT00677443
Brief Title
Study of S-1 and Oxaliplatin (SOX) Versus Capecitabine and Oxaliplatin (COX) in Patients With Advanced Colorectal Cancer
Official Title
A Randomized Phase III Study of SOX vs. COX in Patients With Advanced Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
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
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
metastatic colorectal cancer, S-1, Capecitabine, Oxaliplatin, non-inferiority study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
344 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S-1 and Oxaliplatin
Arm Type
Experimental
Arm Description
S-1 and Oxaliplatin
S-1 : 80 mg/m2/day D1-14 Oxaliplatin : 130 mg/m2/day D1 Repeated every 3 weeks
Arm Title
Capecitabine and Oxaliplatin
Arm Type
Active Comparator
Arm Description
Capecitabine and Oxaliplatin
Intervention Type
Drug
Intervention Name(s)
S-1 & Oxaliplatin
Other Intervention Name(s)
S-1 and Oxaliplatin
Intervention Description
S-1 and Oxaliplatin : S-1 80 mg/m2/day, D1-14 Oxaliplatin, 130 mg/m2/day, D1 Repeated every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Capecitabine & Oxaliplatin
Other Intervention Name(s)
Capecitabine and Oxaliplatin
Intervention Description
COX : Capecitabine 1000 mg/m2/day, D1-14 Oxaliplatin, 130 mg/m2/day, D1 Repeated every 3 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To evaluate and compare the efficacy (overall survival and response rate) in the two treatment groups.
Time Frame
24 months
Title
To evaluate and compare the quality of life of the patients and safety profiles of the two treatment groups.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Suk Park, M.D.,Ph.D.
Organizational Affiliation
Samsung Medical Center, Seoul, Korea
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hye Jin Kang, M.D.,Ph.D.
Organizational Affiliation
Korea Cancer Center Hospital , Seoul, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jee Hyun Kim, M.D.,Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital, Gyeonggi, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tae Won Kim, M.D.,Ph.D.
Organizational Affiliation
Asan Medical Center, Seoul, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tae-Yoo Kim, M.D.,Ph.D.
Organizational Affiliation
Seoul National University Hospital , Seoul, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dong Bok Shin, M.D.,Ph.D.
Organizational Affiliation
Gil Medical Center, Gyeonggi, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joong Bae Ahn, M.D.,Ph.D.
Organizational Affiliation
Yonsei Medical Center, Severance Hospital, Seoul, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kyung Hee Lee, M.D.,Ph.D.
Organizational Affiliation
Yeungnam University College of Medicine , Daegu, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Namsu Lee, M.D.,Ph.D.
Organizational Affiliation
Soon Chun Hyang University Hospital , Seoul, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ik-Joo Chung, M.D.,Ph.D.
Organizational Affiliation
Chonnam National University Hwasun Hospital, Jeollanamdo, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yong Sang Hong, M.D.,Ph.D.
Organizational Affiliation
National Cancer Center, Gyeonggi, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Hwasun
State/Province
Jeollanamdo
ZIP/Postal Code
519-809
Country
Korea, Republic of
Facility Name
Yeungnam University
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Inchon
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Korea Cancer Center Hospital
City
Seoul
ZIP/Postal Code
139-706
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital
City
Seoul
ZIP/Postal Code
140-743
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
25424120
Citation
Kim ST, Hong YS, Lim HY, Lee J, Kim TW, Kim KP, Kim SY, Baek JY, Kim JH, Lee KW, Chung IJ, Cho SH, Lee KH, Shin SJ, Kang HJ, Shin DB, Lee JW, Jo SJ, Park YS. S-1 plus oxaliplatin versus capecitabine plus oxaliplatin for the first-line treatment of patients with metastatic colorectal cancer: updated results from a phase 3 trial. BMC Cancer. 2014 Nov 26;14:883. doi: 10.1186/1471-2407-14-883.
Results Reference
derived
PubMed Identifier
23062232
Citation
Hong YS, Park YS, Lim HY, Lee J, Kim TW, Kim KP, Kim SY, Baek JY, Kim JH, Lee KW, Chung IJ, Cho SH, Lee KH, Shin SJ, Kang HJ, Shin DB, Jo SJ, Lee JW. S-1 plus oxaliplatin versus capecitabine plus oxaliplatin for first-line treatment of patients with metastatic colorectal cancer: a randomised, non-inferiority phase 3 trial. Lancet Oncol. 2012 Nov;13(11):1125-32. doi: 10.1016/S1470-2045(12)70363-7. Epub 2012 Oct 10.
Results Reference
derived
Learn more about this trial
Study of S-1 and Oxaliplatin (SOX) Versus Capecitabine and Oxaliplatin (COX) in Patients With Advanced Colorectal Cancer
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