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

NCT ID: NCT01718626

Last Updated: 2012-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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S1+Docetaxel

Group Type ACTIVE_COMPARATOR

S1+Docetaxel

Intervention Type DRUG

Drug: S1 40-60mg, bid, days1-14, every 3 weeks Docetaxel 50mg/m2, day1, every 3 weeks, Patients will receive S1+Docetaxel until progression

S1+Docetaxel followed by S1

Group Type EXPERIMENTAL

S1+Docetaxel followed by S1

Intervention Type DRUG

Drug: S1 40-60mg, bid, days1-14, every 3 weeks Docetaxel 50mg/m2, day1, every 3 weeks,for 4 cycles; S1 40-60mg, bid, days1-14, every 3 weeks Patients will receive S1+Docetaxel followed by S1 until progression

Interventions

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S1+Docetaxel

Drug: S1 40-60mg, bid, days1-14, every 3 weeks Docetaxel 50mg/m2, day1, every 3 weeks, Patients will receive S1+Docetaxel until progression

Intervention Type DRUG

S1+Docetaxel followed by S1

Drug: S1 40-60mg, bid, days1-14, every 3 weeks Docetaxel 50mg/m2, day1, every 3 weeks,for 4 cycles; S1 40-60mg, bid, days1-14, every 3 weeks Patients will receive S1+Docetaxel followed by S1 until progression

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hebei Tumor Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei Liu

Role: PRINCIPAL_INVESTIGATOR

Hebei Tumor Hospital

Locations

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Department of Medical Oncology

Shijiazhuang, Hebei, China

Site Status

Countries

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China

Other Identifiers

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HBTH101

Identifier Type: -

Identifier Source: org_study_id