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

NCT01747707 | Unknown Phase 2

• 1 other identifier: CH-GI-31
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Gastroesophageal Junction Cancer

Keywords

gastric cancer; gastroesophageal junction cancer; chemotherapy; docetaxel; cisplatin; S-1

Outcome Measures

Primary Outcomes (1)

• overall survival time (OS)

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

  14 months

Secondary Outcomes (2)

• Progression free survival (PFS)

  6 months

• safety profile

  4 months

Study Arms (1)

docetaxel, cisplatin and S-1 (DCS)

EXPERIMENTAL

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; Drug: Cisplatin; Drug: S-1

Interventions

Docetaxel DRUG

Also known as: taxotere

docetaxel, cisplatin and S-1 (DCS)

Cisplatin DRUG

docetaxel, cisplatin and S-1 (DCS)

S-1 DRUG

Also known as: TS-1

docetaxel, cisplatin and S-1 (DCS)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital & Institute, Chinese Academy of Medical Sciences

Beijing, 10021, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; Cisplatin; S 1 (combination); titanium silicide

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Aiping Zhou, M.D

  Cancer Hospital & Institute, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aiping Zhou, M.D

CONTACT

8610-87788145; zhouap1825@126.com

Yongkun Sun, M.D

CONTACT

8610-87788145; hsunyk@tom.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 12, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: May 1, 2014
• Last Updated: December 12, 2012

Record last verified: 2012-12

Locations

CN (1)