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Completed

NCT Number: NCT00891332

Study of S-1 Plus LV for Untreated Metastatic Colorectal Cancer

This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1 week on and 1 week off) as first -line treatment for patients with metastatic colorectal cancer.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center, Division of Oncology, Dong Feng Dong road,Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically proved adenocarcinoma
  • Unresectable and recurrent colorectal cancer
  • Age20 ≤ at enrollment
  • Performance status 0 or 1 (ECOG)
  • 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 containing treatment shall be excluded
  • Adequate hematologic, hepatic and renal functions
  • At least one measurable lesion by RECIST criteria

Exclusion criteria

  • Serious drug hypersensitivity
  • Pregnant or nursing
  • Bleeding from gastrointestinal tract
  • Diarrhea
  • Simultaneously active double cancer
  • Serious illness or medical condition
  • Brain metastasis

Treatment and study plan

S-1 plus LV (The combination therapy of S-1 and Leucovorin)

Drug

S-1 40-60 mg bid day 1～day 7 LV 25 mg bid day 1～day 7

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: During chemotherapy

Secondary outcomes

  1. Safety

    Time frame: During chemotherapy

  2. Progression free survival (PFS)

    Time frame: Until progression

  3. Disease control rate(DCR)

    Time frame: During chemotherapy

  4. Time to treatment failure (TTF)

    Time frame: Until progression

  5. Overall survival (OS)

    Time frame: Over two years from registration

  6. Feasibility

    Time frame: During chemotherapy

  7. Pharmacokinetics

    Time frame: During chemotherapy

Sponsors and collaborators

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Phase II Study of S-1 Plus LV (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic Colorectal Cancer

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 1, 2009
Registry last updated
Jan 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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