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CompletedNCT00721916Updated Nov 1, 2012

Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer

A Phase 2 interventional study of SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin) and mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin) in Colorectal Cancer, sponsored by Taiho Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2012-11-01.

Sponsored by Taiho Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
107
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 107 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Taiho Pharmaceutical Co., Ltd. is the lead sponsor of 43 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Serious drug hypersensitivity.
  • Prior history of peripheral neuropathy.
  • Diarrhea .
  • Simultaneously active double cancer.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
107 participants (actual)

Study arms

  • Experimental
    1

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

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

  • Active comparator
    2

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

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

Interventions

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

    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

  • DrugmFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)

    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)

06

What researchers measure

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: Until progression

Secondary outcomes

  1. Safety

    Time frame: During chemotherapy

07

Study locations

1 site
  • Shizuoka Cancer Center
    Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka 411-8777, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00721916
Lead sponsor
Taiho Pharmaceutical Co., Ltd.
Collaborators
Yakult Honsha Co., LTD
Responsible party
Sponsor
First posted
Jul 25, 2008
Start date
Jul 2008
Primary completion
Mar 2012
Completion
May 2012
Last update
Nov 1, 2012

Study contacts

Narikazu Boku, MD
study chair · St. Marianna University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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