Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer

This study has been completed.
Sponsor:
Collaborator:
Korean Cancer Study Group
Information provided by:
Japan Clinical Cancer Research Organization
ClinicalTrials.gov Identifier:
NCT00287768
First received: February 3, 2006
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

The primary objective of this study is to compare median overall survival of the test arm (docetaxel and S-1) to the control arm (S-1 only) in subjects with advanced or recurrent gastric cancer.


Condition Intervention Phase
Gastric Cancer
Drug: docetaxel + S-1
Drug: S-1
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Study of Docetaxel and S-1 Versus S-1 in the Treatment of Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Japan Clinical Cancer Research Organization:

Primary Outcome Measures:
  • overall survival [ Time Frame: median ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time-to-progression [ Time Frame: From onset of regression to progression ] [ Designated as safety issue: No ]
  • response rate [ Time Frame: response during observation ] [ Designated as safety issue: No ]
  • safety [ Time Frame: side effects during observation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 628
Study Start Date: March 2006
Study Completion Date: October 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Docetaxel + S-1
Drug: docetaxel + S-1
Docetaxel iv on day one and S-1 po days 1 to 14 every 3 weeks
Other Names:
  • taxotere
  • TS-1
Active Comparator: 2
S-1
Drug: S-1
S-1 po days 1-28 every 6 weeks
Other Name: TS-1

Detailed Description:

Seven-hundred and fifty thousand of new gastric cancer cases are diagnosed worldwide per year. Advanced gastric cancer (AGC) is considered nearly incurable with less than 10% of subjects alive 5 years after diagnosis. Therefore, new treatment regimens are needed for subjects with AGC.

S-1, a new oral fluoropyrimidine which consists of the 5-FU prodrug tegafur (ftorafur, FT) and two enzyme inhibitors, CDHP (5-chloro-2,4-dihydroxypyridine) and OXO (potassium oxonate), in a molar ratio of 1(FT):0.4 (CDHP):1(OXO) is commercially available since late 90'in Japan. Phase II trials have demonstrated that S-1 is active, as a single agent, for the treatment of gastric (RR 44.6%), colorectal (RR 37.4%), head and neck, breast, non-small cell lung, and pancreatic cancers. In gastric cancer, phase III trials (JCOG 9912) comparing 5-FU alone and CPT-11/CDDP combination are currently underway and these results are awaited. Despite of JCOG 9912 study is ongoing, 80% of patients of AGC are already treated by S-1, because of high RR and convenience use for out-patient basis. P-II studies S-1/CDDP, S-1/CPT-11 and S-1/Docetaxel showed high RR(55-76%) and long MST(12-14M). Furthermore, P-III studies are already conducted S-1 vs. S-1/CDDP and S-1 vs. S-1/CPT-11 in Japan. The aim of this study is to compare S-1/Docetaxel vs. S-1 alone in the patients of AGC. This study is a prospective, multicenter, multinational, non-blinded, randomized phase III study.

Patients: Inoperable or relapse gastric cancer. Informed consent must be obtained in writing before treatment. Subjects meeting all of the inclusion criteria and exclusion criteria will be considered for enrollment into study. Then patients will be randomly assigned into two groups S-1/Docetaxel(Treatment Arm A) or S-1 alone(Treatment Arm B).

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma
  • Subjects must be able to take orally
  • Measurable lesion and/or non-measurable lesion defined by RECIST
  • ECOG performance status ≦ 1
  • Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3
  • Creatine ≦ upper normal limit (UNL)
  • Total bilirubin ≦ 1.5 X UNL
  • AST, ALT and ALP ≦ 2.5 x UNL
  • No prior chemotherapy
  • Life expectancy estimated than 3 months
  • Written informed consent

Exclusion Criteria:

  • Active double cancer
  • Gastrointestinal bleeding
  • Excessive amounts of ascites require drainage
  • Known brain metastases
  • Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0
  • Pulmonary fibrosis, Intestinal pneumonitis
  • History of hypersensitivity to fluoropyrimidines, docetaxel or medications formulated with polysorbate 80
  • Any previous chemotherapy or radiotherapy for AGC
  • Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
  • Treatment with any investigational product during the last 4 weeks prior to study entry
  • Definite contraindications for the use of corticosteroids
  • Any subject judged by the investigator to be unfit for any reason to participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287768

  Show 116 Study Locations
Sponsors and Collaborators
Japan Clinical Cancer Research Organization
Korean Cancer Study Group
Investigators
Principal Investigator: Masashi Fujii, MD PhD Surugadai Nihon University Hospital
  More Information

No publications provided by Japan Clinical Cancer Research Organization

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Masashi Fujii / Associate Professor, Department of Surgery, Surugadai Nippon University
ClinicalTrials.gov Identifier: NCT00287768     History of Changes
Other Study ID Numbers: JACCRO GC-03
Study First Received: February 3, 2006
Last Updated: June 27, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Cancer Research Organization:
gastric cancer
advanced gastric cancer
S-1
docetaxel
phase III study

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014