Cisplatin,Docetaxel and S-1 for Advanced Gastric and Gastroesophageal Junction Cancer

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT01747707

Collaborator

(none)

Enrollment

Location

Arm

19.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The combination of Cisplatin and S-1 (CS) achieved a response rate of approximately 45% with the PFS being around 6 months and overall survival time being 13 months in Japanese and Chinese gastric patients. It remains unclear whether the addition of docetaxel to CS would further enhance the efficacy as it dose in DCF(docetaxel, cisplatin and 5-fluorouracil). This is a single center, phase II clinical trial to evaluate the efficacy of docetaxel, cisplatin and S-1 (DCS) as first line chemotherapy for patients with advanced gastric and gastroesophageal junction cancer.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Gastroesophageal Junction Cancer	Drug: Docetaxel Drug: Cisplatin Drug: S-1	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2012

Anticipated Primary Completion Date :

Sep 1, 2013

Anticipated Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: docetaxel, cisplatin and S-1 (DCS) All patients receive the combination therapy of docetaxel, cisplatin and S-1 for a maximum of 6 cycles. Docetaxel 60mg/m2 IV infusion over 1 hour on d1; Cisplatin 30mg/m2 IV infusion on d1,2; S-1 40mg orally twice a day for patients with the body surface area (BSA) less than 1.25m2, 50mg twice a day with the BSA between 1.25 and 1.5m2, 60mg twice a day with the BSA over 1.5m2.	Drug: Docetaxel Other Names: taxotere Drug: Cisplatin Drug: S-1 Other Names: TS-1

Arm

Intervention/Treatment

Experimental: docetaxel, cisplatin and S-1 (DCS)

All patients receive the combination therapy of docetaxel, cisplatin and S-1 for a maximum of 6 cycles. Docetaxel 60mg/m2 IV infusion over 1 hour on d1; Cisplatin 30mg/m2 IV infusion on d1,2; S-1 40mg orally twice a day for patients with the body surface area (BSA) less than 1.25m2, 50mg twice a day with the BSA between 1.25 and 1.5m2, 60mg twice a day with the BSA over 1.5m2.

Drug: Docetaxel

Other Names:

taxotere

Drug: Cisplatin

Drug: S-1

Other Names:

TS-1

Outcome Measures

Primary Outcome Measures

overall survival time (OS) [14 months]
To determine the OS of DCS in patients with chemo-naive, advanced gastric or gastroesophageal junction cancer.

Secondary Outcome Measures

Progression free survival (PFS) [6 months]
To determine the PFS of DCS in patients with chemo-naive, gastric or gastroesophageal junction cancer
safety profile [4 months]
To determine the tolerability of DCS in patients with chemo-naive, gastric or gastroesophageal junction cancer.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 bleeding;
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.