Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00721916

Enrollment

107

Registered

2008-07-25

Start date

2008-07-31

Completion date

2012-05-31

Last updated

2012-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Progression free survival (PFS)	Until progression

Secondary

Measure	Time frame
Safety	During chemotherapy

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026