Study Comparing Sequential Therapy of S1+Docetaxel Followed by S1 to Concomitant S1+Docetaxel for Advanced Gastric Cancer

Phase 2

• Conditions: Gastric Cancer
• Interventions: Drug: S1+Docetaxel; Drug: S1+Docetaxel followed by S1

• Registration Number: NCT01718626
• Lead Sponsor: Hebei Tumor Hospital

Brief Summary

Stage 1:First line therapy Sequential therapy of S1+Docetaxel followed by S1 is superior to concomitant S1+Docetaxel in the safety and clinical efficiency.

Stage 2:Second line therapy To explore the feasibility of single drug(S1) maintenance treatment for advanced gastric cancer.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-10
• Study Start: 2012-10
• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-10-28
• Study First Posted: 2012-10-31
• Last Update Submitted: 2012-11-05
• Last Update Posted: 2012-11-06
• Primary Completion: 2013-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Signed informed consent form
• Performance Status-Eastern Cooperative Oncology Group (ECOG) 0-1
• Histologically or cytologically confirmed gastric cancer
• Advanced or recurrent, metastatic disease
• At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
• Life expectancy of at least 3 months
• Target target lesion has not received radiotherapy or non target lesion radiation at least 4 weeks
• Haematopoietic and Hepatic status:

Absolute neutrophil count >1.5x109/L,Platelet count > 100 x 109/L,Hemoglobin at least 9 g/dl,Bilirubin ≤ 1.5 x upper limit of normal (ULN),AST and ALT ≤ 2.5 times ULN(no liver metastasis), ≤5 times ULN(with liver metastasis)

• Cardiovascular: Baseline LVEF 50% measured by echocardiography

Exclusion Criteria

• Symptomatic brain metastasis
• Active or uncontrolled infection
• Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2; peripheral neuropathy of grade 2 or greater Symptomatic brain metastasis
• Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, uncontrolled hypertension (≥ 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen
• History of other malignancy
• Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S1+Docetaxel	S1+Docetaxel	-
S1+Docetaxel followed by S1	S1+Docetaxel followed by S1	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival(PFS)	1 years

Secondary Outcome Measures

Name	Time	Method
Disease control rate(DCR)	1 year
Overall survival(OS)	3 years
Objective response rate(ORR)	1 year

Trial Locations

Locations (1)

Department of Medical Oncology; 🇨🇳 Shijiazhuang, Hebei, China