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Trial Title:
Cisplatin,Docetaxel and S-1 for Advanced Gastric and Gastroesophageal Junction Cancer
NCT ID:
NCT01747707
Condition:
Gastric Cancer
Gastroesophageal Junction Cancer
Conditions: Official terms:
Stomach Neoplasms
Docetaxel
Conditions: Keywords:
gastric cancer
gastroesophageal junction cancer
chemotherapy
docetaxel
cisplatin
S-1
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Docetaxel
Arm group label:
docetaxel, cisplatin and S-1 (DCS)
Other name:
taxotere
Intervention type:
Drug
Intervention name:
Cisplatin
Arm group label:
docetaxel, cisplatin and S-1 (DCS)
Intervention type:
Drug
Intervention name:
S-1
Arm group label:
docetaxel, cisplatin and S-1 (DCS)
Other name:
TS-1
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital & Institute, Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
10021
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongkun Sun, M.D
Phone:
8610-87788145
Email:
hsunyk@tom.com
Start date:
September 2012
Completion date:
May 2014
Lead sponsor:
Agency:
Chinese Academy of Medical Sciences
Agency class:
Other
Source:
ChineseAMS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01747707
