Randomized phase II trial of TS-1 monotherapy versus TS-1 plus gemcitabine therapy in patients with gemcitabine-resistant advanced pancreatic cancer

UMIN ID: UMIN000001103

Registered date:01/04/2008

Basic Information

• Health condition(s) or Problem(s) studied: Patients with unresectable advanced pancreatic cancer (Stage IV, TNM Classification) who were primarily resistant to gemcitabine monotherapy
• Date of first enrollment: 2007/11/01
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Arm 1: S-1 monotherapy Patients who enrolled this study will receive either arm of the therapy 3 weeks after their prior treatment has finished. In the S-1 arm, S-1 is given orally for four weeks, followed by a 2-week rest. as two divided doses (after breakfast and dinner), determined according to body surface area (BSA): BSA below 1.25 m2, 80 mg; 1.25 to 1.5 m2, 100 mg and BSA over1.5 m2, 120 mg. This course is repeated until progressive disease or severe toxicities are confirmed.
Arm 2: S-1/Gem Patients who enrolled this study will receive either arm of the therapy 3 weeks after their prior treatment has finished. In the S-1/Gem arm, Gemcitabine (1000 mg/m2) is given by intravenous infusion over 30 minutes on days 8 and 15, followed by a 1-week rest. However, if the dose is reduced in patients during the first-line chemotherapy, administration should be started after reducing the dose of gemcitabine to 800 mg/m2. S-1 is given orally for two weeks from Day 1 to 14, followed by a 1-week rest. as two divided doses (after breakfast and dinner), determined according to body surface area (BSA): BSA below 1.25 m2, 60 mg; 1.25 to 1.5 m2, 80 mg and BSA over1.5 m2, 100 mg. This course is repeated until progressive disease or severe toxicities are confirmed.

Outcome(s)

• Primary Outcome: disease control rate
• Secondary Outcome: progression-free survival, overall survival, adverse event, QOL

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Exclusion criteria are as follows: 1) Prior history of radiation therapy to pancreatic cancer 2) Presence of other active malignancy 3) Presence of severe complications such as plumonary fibrosis, interstitial pneumonia, intestinal paralysis, uncontrolled diabetes, uncontrolled hypertension, myocardial infarction within six months, unstable angina, severe infection, renal failure, liver failure, , etc 4) Past history of allergic reaction to gemcitabine 5) Regular use of frucitocin, fenitoin or warfarin 6) Past history of radiation therapy to the lung(s). 7) Massive ascites or pleural effusion 8) Severe diarrhea 9) active intestinal bleeding 10) Pregnancy, breast feeding, or women who desire to preserve fecundity or men who desire to have children 11) Severe mental disorder 12) regular use of steroids 13) Inadequate physical condition, as diagnosed by primary physician

Related Information

• Primary Sponsor: Keio University School of Medicine, Department of Medicine, Division of Gastroenterology
• Source(s) of Monetary Support: Keio University School of Medicine