Clinical trial NCT01747707: Cisplatin,Docetaxel and S-1 for Advanced Gastric and Gastroesophageal Junction Cancer
Official title: Phase II Clinical Trial of Cisplatin,Docetaxel and S-1 as First Line Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Gastroesophageal Junction Cancer
Keywords: gastric cancer
gastroesophageal junction cancer
chemotherapy
docetaxel
cisplatin
S-1
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2012-12-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: overall survival time (OS)
timeFrame: 14 months
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: 6 months
measure: safety profile
timeFrame: 4 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital & Institute, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Hospital & Institute, Chinese Academy of Medical Sciences
name: Aiping Zhou, M.D
role: PRINCIPAL_INVESTIGATOR
References: