Phase III of Gemcitabine Vs TS-1 Vs Gemcitabine Plus TS-1 in Pancreatic Cancer

Phase 3

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: TS-1; Drug: Gemcitabine; Drug: Gemcitabine plus TS-1

• Registration Number: NCT00498225
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Brief Summary

In patients with unresectable advanced pancreatic cancer, non-inferiority of TS-1 monotherapy and superiority of GEM + TS-1 combination therapy to gemcitabine (GEM) will be verified using survival time.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-06
• Study First Submitted QC: 2007-07-06
• Study First Posted: 2007-07-09
• Primary Completion: 2011-07
• Study Completion: 2012-06
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-01
• Last Update Posted: 2012-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 834

Inclusion Criteria

• Pancreatic carcinoma histologically determined to be adenocarcinoma or adenosquamous carcinoma.
• Advanced unresectable pancreatic (including pancreatic cancer with local progression and recurrent pancreatic cancer).Presence/absence of measurable lesions is not considered. Patients with measurable lesions must undergo diagnostic imaging tests within 28 days before registration.
• Patients with no previous treatment (radiotherapy,chemotherapy etc) for pancreatic cancer, except resection. Intra-operative radiotherapy during resection of pancreatic cancer will be permitted, although registration must occur at least 4 weeks after the radiotherapy. Patients that have undergone preoperative/postoperative adjuvant chemotherapy may be enrolled if relapse is diagnosed beyond week 24 after the final administration (on day 169 when the day following the final day is set as day 1).
• Age: 20 years to 79 years.
• ECOG Performance Status (PS) of 0 or 1.
• Sufficient function of major organs as defined below. (The following criteria are satisfied in laboratory tests conducted within 14 days before registration. Laboratory tests conducted 2 weeks before registration (on the same weekday) will be included.) White blood cell count≥ 3500/mm3 Neutrophil count≥ 2000/mm3 Hemoglobin≥9.0 g/dL Platelet count≥100000/mm3 Total bilirubin≤ 2.0 mg/dL* *≤ 3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice. AST and ALT≤ 150 U/L Serum creatinine≤1.2 mg/dL Creatinine clearance≥50mL/min.** **Measured values will be used if available. Otherwise, values calculated by the Cockcroft-Gault method will be used.Formula for estimation:body weight (kg) x [140 - age (years) / 72 x serum creatinine (mg/dL)] *Estimated value will be multiplied by 0.85 for females.
• Able to take capsules orally.
• No clinically abnormal ECG findings within 28 days (4 weeks)before registration.
• Voluntarily signed the written consent form.

Exclusion Criteria

• Pulmonary fibrosis or interstitial pneumonia (to be confirmed by chest X-ray within 28 days before enrollment).
• Watery diarrhoea.
• Active infections (e.g. patients with pyrexia of 38°C or greater), excluding viral hepatitis.
• Serious complications (e.g. heart failure, renal failure,hepatic failure, haemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes).
• Moderate or severe (requiring drainage) ascites or pleural effusion requiring treatment.
• Metastasis in the CNS.
• Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 3 years or less). Carcinoma in situ and lesions of intramucosal carcinoma will not be included in active double cancer and will be permitted for registration.
• Patients under treatment with flucytosine, phenytoin or warfarin potassium.
• Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy.
• Severe mental disorder.
• Judged ineligible by physicians for participation in the study from a safety viewpoint.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	TS-1	TS-1
3	Gemcitabine	Gemcitabine
1	Gemcitabine plus TS-1	Gemcitabine plus TS-1

Primary Outcome Measures

Name	Time	Method
Over all survival(OS)	every course for first three courses, then every other course

Secondary Outcome Measures

Name	Time	Method
progression-free survival (PFS), response rate (RECIST, if measurable), incidence rate of adverse events, incidence rate of adverse drug reactions, QOL (EQ-5D)	adverse events will be collected during treatment

Trial Locations

Locations (12)

Chang Gung Memorial Hospital, Kaohsiung; 🇨🇳 No.123, Ta-Pei Rd., Niao-Sung Hsiang, Kaohsiung Hsien, Taiwan

Chung-Ho Memorial Hospital, Kaohsiung Medical University; 🇨🇳 No.100, Tzyou 1st Rd., Kaohsiung, Taiwan

National Cancer Center Hospital; 🇯🇵 Tokyo, Japan

Changhua Christian Hospital; 🇨🇳 No.135, Nanxiao St., Changhua, Taiwan

National Cheng Kung University Hospital; 🇨🇳 No.138, Sheng Li Road,Tainan, Taiwan

Mackay Memorial Hospital, Taipei; 🇨🇳 No.92, Sec. 2, Zhongshan N. Rd., Taipei, Taiwan

Chi Mei Medical Center; 🇨🇳 No.901, Chung Hwa Rd., Yong Kang city, Tainan, Taiwan

National Taiwan University Hospital; 🇨🇳 No.7, Chung San South Road, Taipei, Taiwan

China Medical University Hospital; 🇨🇳 No.2, Yuh-Der Rd.,Taichung, Taiwan

Chi Mei Medical Center Liou Ying Campus; 🇨🇳 No.201, Taikang Village, Liou Ying Township, Tainan, Taiwan

Chang Gung Memorial Hospital, Lonkou; 🇨🇳 No.5, Fu-Hsing St. Kuei Shan Hsiang, Taoyuan Hsien, Taiwan

Taipei Veterans General Hospital; 🇨🇳 No.201, Sec. 2, Shih-Pai road, Taipei, Taiwan