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

November 1, 2012 updated by: Taiho Pharmaceutical Co., Ltd.

Randomized Phase III Study of Gemcitabine Versus TS-1 Versus Gemcitabine Plus TS-1 in Unresectable Advanced Pancreatic Cancer (With Local Progression or Metastasis)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

834

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
  • Taiwan
      • No.100, Tzyou 1st Rd., Kaohsiung, Taiwan, 807
        • Chung-Ho Memorial Hospital, Kaohsiung Medical University
      • No.123, Ta-Pei Rd., Niao-Sung Hsiang, Kaohsiung Hsien, Taiwan, 833
        • Chang Gung Memorial Hospital, Kaohsiung
      • No.135, Nanxiao St., Changhua, Taiwan, 500
        • Changhua Christian Hospital
      • No.138, Sheng Li Road,Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • No.2, Yuh-Der Rd.,Taichung, Taiwan, 404
        • China Medical University Hospital
      • No.201, Sec. 2, Shih-Pai road, Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
      • No.201, Taikang Village, Liou Ying Township, Tainan, Taiwan, 736
        • Chi Mei Medical Center Liou Ying Campus
      • No.5, Fu-Hsing St. Kuei Shan Hsiang, Taoyuan Hsien, Taiwan, 333
        • Chang Gung Memorial Hospital, Lonkou
      • No.7, Chung San South Road, Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • No.901, Chung Hwa Rd., Yong Kang city, Tainan, Taiwan, 710
        • Chi Mei Medical Center
      • No.92, Sec. 2, Zhongshan N. Rd., Taipei, Taiwan, 104
        • Mackay Memorial Hospital, Taipei

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Gemcitabine plus TS-1
Drug: Gemcitabine plus TS-1
Gemcitabine plus TS-1:Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8 followed by 2 week rest as 1 course. TS-1 was co-administered orally at 40 mg/m2 twice daily for 14 days with a rest period of 1 week as one course.
Experimental: 2
TS-1
Drug: TS-1
TS-1 was administered orally at 40 mg/m2 twice daily for 28 days with a rest period of 2week as one course.
Active Comparator: 3
Gemcitabine
Drug: Gemcitabine
Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8, 15 followed by 2 week rest as 1 course.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Over all survival(OS)
Time Frame: every course for first three courses, then every other course
every course for first three courses, then every other course

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiho Pharmaceutical Co., Ltd.

Collaborators

TTY Biopharm

Investigators

  • Principal Investigator: Takuji Okusaka, MD, National Cancer Center Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

July 6, 2007

First Submitted That Met QC Criteria

July 6, 2007

First Posted (Estimate)

July 9, 2007

Study Record Updates

Last Update Posted (Estimate)

November 2, 2012

Last Update Submitted That Met QC Criteria

November 1, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01023017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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