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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


Phase 2
20 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival (PFS)

Outcome Time Frame:

Until progression

Safety Issue:

No

Principal Investigator

Narikazu Boku, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Marianna University School of Medicine

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

Taiho10020390

NCT ID:

NCT00721916

Start Date:

July 2008

Completion Date:

May 2012

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

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