Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) for Advanced Colorectal Cancer
Primary Purpose
Colorectal Neoplasm
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
OS (oxalipaltin+S-1)
XELOX (oxalipaltin+capecitabine)
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasm focused on measuring Colorectal Neoplasm, S-1, Capecitabine, Oxaliplatin
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed colorectal adenocarcinoma, initially diagnosed or recurred
- Unresectable, locally advanced or metastatic
- At least one uni-dimensional measurable lesion by RECIST criteria
- Age 18 to 75 years old
- Estimated life expectancy ≥3 months
- ECOG performance status ≤2
- Adequate bone marrow function (WBCs ≥ 4,000/µL or absolute neutrophil count ≥ 1,500/µL, platelets ≥ 100,000/µL)
- Adequate kidney function (creatinine < 1.5 mg/dL)
- Adequate liver function (bilirubin < 2.0 mg/dL, transaminase levels <2.5 times the upper normal limit)
- Written informed consent
Exclusion Criteria:
- Other tumor type than adenocarcinoma
- Previous history of chemotherapy (exception : neoadjuvant or adjuvant chemotherapy without oxaliplatin)
- Presence of CNS metastasis, psychosis, or seizure
- Obvious bowel obstruction
- Evidence of serious gastrointestinal bleeding
- Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions
Sites / Locations
- Hallym University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
OS (oxalipaltin+S-1)
XELOX (oxalipaltin+capecitabine)
Arm Description
OS (oxaliplatin + S-1): Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA <1.25 40mg bid (total 80mg/day); BSA ≥1.25 - <1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days
XELOX (oxalipaltin+capecitabine): Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
Outcomes
Primary Outcome Measures
overall response rate
Secondary Outcome Measures
Safety, time to progression, and overall survival
Full Information
NCT ID
NCT00677144
First Posted
May 7, 2008
Last Updated
October 4, 2012
Sponsor
Hallym University Medical Center
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT00677144
Brief Title
Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) for Advanced Colorectal Cancer
Official Title
A Randomized Phase II Study of Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) in Patients With Advanced or Recurrent Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hallym University Medical Center
Collaborators
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to compare the activity and safety of Oxaliplatin and S-1 (OS) and Oxaliplatin and Capecitabine (XELOX) in patients with advance or recurrent colorectal cancer.
Detailed Description
Oxaliplatin and oral fluoropyrimidines (capecitabine or S-1) are active agents for colorectal cancer. Recent a phase II trial of combination chemotherapy of oxaliplatin with S-1 (OS) and several phase II trial of combination chemotherapy of oxaliplatin with capecitabine (XELOX) demonstrated good activity and mild toxicity in advanced colorectal cancer. Oxaliplatin and S-1 or capecitabine have distinct mechanisms of action and no overlap of key toxicities. Furthermore, oxaliplatin and fluorouracil were shown to be highly synergistic, not only in preclinical models but also in subsequent clinical trials.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasm
Keywords
Colorectal Neoplasm, S-1, Capecitabine, Oxaliplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OS (oxalipaltin+S-1)
Arm Type
Experimental
Arm Description
OS (oxaliplatin + S-1): Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA <1.25 40mg bid (total 80mg/day); BSA ≥1.25 - <1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days
Arm Title
XELOX (oxalipaltin+capecitabine)
Arm Type
Active Comparator
Arm Description
XELOX (oxalipaltin+capecitabine): Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
Intervention Type
Drug
Intervention Name(s)
OS (oxalipaltin+S-1)
Other Intervention Name(s)
Eloxatin, TS-1
Intervention Description
Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA <1.25 40mg bid (total 80mg/day); BSA ≥1.25 - <1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days
Intervention Type
Drug
Intervention Name(s)
XELOX (oxalipaltin+capecitabine)
Other Intervention Name(s)
Eloxatin, Xeloda
Intervention Description
Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
Primary Outcome Measure Information:
Title
overall response rate
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Safety, time to progression, and overall survival
Time Frame
4.6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed colorectal adenocarcinoma, initially diagnosed or recurred
Unresectable, locally advanced or metastatic
At least one uni-dimensional measurable lesion by RECIST criteria
Age 18 to 75 years old
Estimated life expectancy ≥3 months
ECOG performance status ≤2
Adequate bone marrow function (WBCs ≥ 4,000/µL or absolute neutrophil count ≥ 1,500/µL, platelets ≥ 100,000/µL)
Adequate kidney function (creatinine < 1.5 mg/dL)
Adequate liver function (bilirubin < 2.0 mg/dL, transaminase levels <2.5 times the upper normal limit)
Written informed consent
Exclusion Criteria:
Other tumor type than adenocarcinoma
Previous history of chemotherapy (exception : neoadjuvant or adjuvant chemotherapy without oxaliplatin)
Presence of CNS metastasis, psychosis, or seizure
Obvious bowel obstruction
Evidence of serious gastrointestinal bleeding
Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
Pregnant or lactating women, women of childbearing potential not employing adequate contraception
Other serious illness or medical conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Young Zang, MD, PhD
Organizational Affiliation
Hallym University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Medical Center
City
Anyang
ZIP/Postal Code
431-070
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) for Advanced Colorectal Cancer
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