Back to results

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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

4. Oversight

Data Monitoring Committee

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

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

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: