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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
Hallym University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasm focused on measuring Colorectal Neoplasm, S-1, Capecitabine, Oxaliplatin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 7, 2008
Last Updated
October 4, 2012
Sponsor
Hallym University Medical Center
Collaborators
Sanofi
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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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