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

NCT01718626 | Unknown Phase 2

• 1 other identifier: HBTH101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival(PFS)

  1 years

Secondary Outcomes (3)

• Objective response rate(ORR)

  1 year

• Disease control rate(DCR)

  1 year

• Overall survival(OS)

  3 years

Study Arms (2)

S1+Docetaxel

ACTIVE COMPARATOR

Drug: S1+Docetaxel

S1+Docetaxel followed by S1

EXPERIMENTAL

Drug: S1+Docetaxel followed by S1

Interventions

S1+Docetaxel 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

S1+Docetaxel followed by S1 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

S1+Docetaxel followed by S1

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebei Tumor Hospital: lead

Study Sites (1)

Department of Medical Oncology

Shijiazhuang, Hebei, 050011, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Wei Liu

  Hebei Tumor Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 31, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: November 6, 2012

Record last verified: 2012-10

Locations

CN (1)