search
Back to results

Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)
mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)
Sponsored by
Taiho Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically proved adenocarcinoma (colorectal cancer).
  • Age: 20 ≤ at enrollment.
  • No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 or Oxaliplatin containing treatment shall be excluded.
  • At least one measurable lesion by RECIST criteria

Exclusion Criteria:

  • Serious drug hypersensitivity.
  • Prior history of peripheral neuropathy.
  • Diarrhea .
  • Simultaneously active double cancer.

Sites / Locations

  • Shizuoka Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)

mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)

Outcomes

Primary Outcome Measures

Progression free survival (PFS)

Secondary Outcome Measures

Safety

Full Information

First Posted
July 23, 2008
Last Updated
October 31, 2012
Sponsor
Taiho Pharmaceutical Co., Ltd.
Collaborators
Yakult Honsha Co., LTD
search

1. Study Identification

Unique Protocol Identification Number
NCT00721916
Brief Title
Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer
Official Title
Randomized Phase II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) Versus 5-FU, l-LV and Oxaliplatin Combination Therapy (mFOLFOX6) in Patients With Untreated Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Pharmaceutical Co., Ltd.
Collaborators
Yakult Honsha Co., LTD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, multicenter study designed to evaluate the progression free survival of the SOL group (S-1, Leucovorin, and Oxaliplatin) compared with the mFOLFOX6 group (5-FU, l-LV and Oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)
Arm Title
2
Arm Type
Active Comparator
Arm Description
mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)
Intervention Type
Drug
Intervention Name(s)
SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)
Intervention Description
L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle S-1 40-60 mg bid day 1～day 7 LV 25 mg bid day 1～day 7
Intervention Type
Drug
Intervention Name(s)
mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)
Intervention Description
L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle l-LV 200 mg/m2 iv. for 2 hr on day 1 5-FU 400 mg/m2 bolus on day 1 5-FU 2400 mg/m2 ci for 46 hr (day 1, 2hr～48hr)
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Time Frame
Until progression
Secondary Outcome Measure Information:
Title
Safety
Time Frame
During chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proved adenocarcinoma (colorectal cancer). Age: 20 ≤ at enrollment. No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 or Oxaliplatin containing treatment shall be excluded. At least one measurable lesion by RECIST criteria Exclusion Criteria: Serious drug hypersensitivity. Prior history of peripheral neuropathy. Diarrhea . Simultaneously active double cancer.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Narikazu Boku, MD
Organizational Affiliation
St. Marianna University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Shizuoka Cancer Center
City
Shimonagakubo Nagaizumi-cho Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer

We'll reach out to this number within 24 hrs