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

Hebei Tumor Hospital

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: S1+Docetaxel; Drug: S1+Docetaxel followed by S1

Study type: Interventional

Funder types: Other

Identifiers

NCT01718626

HBTH101

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

S1+Docetaxel

Active Comparator group

Treatment:

Drug: S1+Docetaxel

S1+Docetaxel followed by S1

Experimental group

Treatment:

Drug: S1+Docetaxel followed by S1