search
Back to results

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

Primary Purpose

Gastric Cancer, Gastroesophageal Junction Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel
Cisplatin
S-1
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, gastroesophageal junction cancer, chemotherapy, docetaxel, cisplatin, S-1

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cancer Hospital & Institute, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

docetaxel, cisplatin and S-1 (DCS)

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 10, 2012
Last Updated
December 10, 2012
Sponsor
Chinese Academy of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01747707
Brief Title
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

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastroesophageal Junction Cancer
Keywords
gastric cancer, gastroesophageal junction cancer, chemotherapy, docetaxel, cisplatin, S-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
docetaxel, cisplatin and S-1 (DCS)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
taxotere
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
S-1
Other Intervention Name(s)
TS-1
Primary Outcome Measure Information:
Title
overall survival time (OS)
Description
To determine the OS of DCS in patients with chemo-naive, advanced gastric or gastroesophageal junction cancer.
Time Frame
14 months
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
To determine the PFS of DCS in patients with chemo-naive, gastric or gastroesophageal junction cancer
Time Frame
6 months
Title
safety profile
Description
To determine the tolerability of DCS in patients with chemo-naive, gastric or gastroesophageal junction cancer.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aiping Zhou, M.D
Phone
8610-87788145
Email
zhouap1825@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yongkun Sun, M.D
Phone
8610-87788145
Email
hsunyk@tom.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aiping Zhou, M.D
Organizational Affiliation
Cancer Hospital & Institute, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital & Institute, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
10021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongkun Sun, M.D
Phone
8610-87788145
Email
hsunyk@tom.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs