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

Gastric Cancer Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01718626
• Other study ID #: HBTH101
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 25, 2012
• Last updated: November 5, 2012
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2012
• Source: Hebei Tumor Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
China	Department of Medical Oncology	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival(PFS)		1 years	Yes
Secondary	Objective response rate(ORR)		1 year	Yes
Secondary	Disease control rate(DCR)		1 year	Yes
Secondary	Overall survival(OS)		3 years	No