- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01747707
Cisplatin,Docetaxel and S-1 for Advanced Gastric and Gastroesophageal Junction Cancer
December 10, 2012 updated by: Aiping Zhou, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase II Clinical Trial of Cisplatin,Docetaxel and S-1 as First Line Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aiping Zhou, M.D
- Phone Number: 8610-87788145
- Email: zhouap1825@126.com
Study Contact Backup
- Name: Yongkun Sun, M.D
- Phone Number: 8610-87788145
- Email: hsunyk@tom.com
Study Locations
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-
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Beijing, China, 10021
- Recruiting
- Cancer Hospital & Institute, Chinese Academy of Medical Sciences
-
Contact:
- Yongkun Sun, M.D
- Phone Number: 8610-87788145
- Email: hsunyk@tom.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival time (OS)
Time Frame: 14 months
|
To determine the OS of DCS in patients with chemo-naive, advanced gastric or gastroesophageal junction cancer.
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14 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival (PFS)
Time Frame: 6 months
|
To determine the PFS of DCS in patients with chemo-naive, gastric or gastroesophageal junction cancer
|
6 months
|
safety profile
Time Frame: 4 months
|
To determine the tolerability of DCS in patients with chemo-naive, gastric or gastroesophageal junction cancer.
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Aiping Zhou, M.D, Cancer Hospital & Institute, Chinese Academy of Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Anticipated)
September 1, 2013
Study Completion (Anticipated)
May 1, 2014
Study Registration Dates
First Submitted
December 10, 2012
First Submitted That Met QC Criteria
December 10, 2012
First Posted (Estimate)
December 12, 2012
Study Record Updates
Last Update Posted (Estimate)
December 12, 2012
Last Update Submitted That Met QC Criteria
December 10, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
- Cisplatin
Other Study ID Numbers
- CH-GI-31
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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