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Phase II Clinical Trial of Cisplatin,Docetaxel and S-1 as First Line Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer

Phase 2
18 Years
75 Years
Open (Enrolling)
Gastric Cancer, Gastroesophageal Junction Cancer

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Trial Information

Phase II Clinical Trial of Cisplatin,Docetaxel and S-1 as First Line Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer

This is a single arm trial. All Patients will receive up to 6 cycles of triple chemotherapy
with docetaxel, cisplatin and S-1. Given the severe toxicity of DCF regimen, here the total
dose of docetaxel and cisplatin is both reduced to 60mg/m2. For patients with CR/PR/SD
disease after 6 cycles of chemotherapy, maintenance therapy with S-1 are recommended.
Antitumor activity will be evaluated every two cycles according to RECIST1.1.

Inclusion Criteria:

- Histologically or cytologically confirmed unresectable advanced gastric or
gastroesophageal junction cancer;

- No previous chemotherapy and radiation for advanced disease except palliative
radiation for a local pain control;

- At least one evaluable lesion per RECIST (Response Evaluation Criteria in Solid
Tumors) 1.1;

- ECOG (Eastern Cooperative Oncology Group) performance status 0-1;

- Recovery from the toxicities of previous therapy;

- Adequate bone marrow and organ function. Hb≥8 G/L; Absolute neutrophil ≥ 2.0 G/L; PLT
≥100 G/L ;ALT/AST ≤1.5 ULN or ≤5ULN with liver metastases; TBIL ≤1.5 ULN; Cr≤1.0 ULN;

- Life expectancy ≥3 months;

- For men and women of childbearing potential, agree on taking effective contraceptive
method of birth control from the signed informed consent until 3 months after the
last study drug administration;

- Signed informed consent.

Exclusion Criteria:

- Pathology type other than adenocarcinoma,such as squamous cell carcinoma;

- Previous treatment with taxanes, cisplatin or S-1;

- Relapse within 6 months after the end of adjuvant chemotherapy;

- Known brain metastases;

- Complete or incomplete intestinal obstruction or uncontrolled gastrointestinal

- Known deficiency of DPD enzyme;

- Kown HIV infecton or drug addiction;

- Any acute or chronic medical or psychiatric condition that would make the patient
inappropriate for entry into this trial in the judgement of investigators;

- Myocardial infarction within 6 months prior to the entry of this trial;

- Known history of allergic reaction to taxanes and platinum;

- Pregnant or breast feeding women.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival time (OS)

Outcome Description:

To determine the OS of DCS in patients with chemo-naive, advanced gastric or gastroesophageal junction cancer.

Outcome Time Frame:

14 months

Safety Issue:


Principal Investigator

Aiping Zhou, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Hospital & Institute, Chinese Academy of Medical Sciences


China: State Food and Drug Adminstration

Study ID:




Start Date:

September 2012

Completion Date:

May 2014

Related Keywords:

  • Gastric Cancer
  • Gastroesophageal Junction Cancer
  • gastric cancer
  • gastroesophageal junction cancer
  • chemotherapy
  • docetaxel
  • cisplatin
  • S-1
  • Stomach Neoplasms