Clinical trial NCT01963702: A Phase II Trial of Exploring the Predictive Factors of TX and XELOX Regimen in the First Line Treatment of MGC
Official title: Phase II Trial of Exploring the Predictive Factors of Docetaxol Plus Capecitabine(TX) Regimen and Oxaliplatin Plus Capecitabine (XELOX) Regimen in the First Line Treatment of Patients With Metastatic Gastric Cancer (MGC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: predictive factor
response
gastric neoplasm
oxaliplatin
docetaxol
capecitabine
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Platinum, fluorouracil and taxane based regimen are all acceptable in the first line treatment of metastatic gastric cancer. The TX and XELOX regimen are two common regimen used in MGC. whichever regimen is used, the average response rate is less than 50%. So a rather part of patients can't get benefit from the treatment. It is urgent to find out the predictive factors of these regimens in order to get a higher response and better survival outcome.

Detailed description: Patients with MGC will be treated with TX or XELOX regimen. Before treatment, 14 days after treatment and after progression, the blood sample will be collected. Primary tumor blocks will also of collected. These samples will be used to detect predictive factors of the two types first line therapy.

Eligibility criteria: Inclusion Criteria:

* Chemo-naive patients with metastatic, unresectable, histologically confirmed gastric or Gastroesophageal adenocarcinoma; Patients who received adjuvant chemotherapy, the duration from the last therapy to relapse at least longer than 6 months
* Patient must have at least one measurable lesions (RECIST 1.1)
* 18 Years to 75 years
* Written informed consent obtained
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patients must have adequate organ and marrow function as defined below:
* neutrophilicgranulocyte greater than/equal to 1,500/mm3;
* platelets greater than/equal to 90,000/ mm3;
* hemoglobin greater than/equal to 9 gm/dL (may be transfused to maintain or exceed this level);
* total bilirubin less than/equal to 1.5 within institutional upper limit of normal (IULN);
* Aspartate Transaminase (AST,SGOT)/Alanine transaminase (ALT,SGPT) less than/equal to 2.5 times IULN
* serum creatinine less than/equal to 1.5 x IULN.

Exclusion Criteria:

* Active clinically serious infections (\> grade 2 NCI-CTC version 3.0, National Cancer Institute-Common Terminology Criteria for Adverse Events)
* Symptomatic metastatic brain or meningeal tumors
* History of organ allograft
* Patients undergoing renal dialysis
* chronic inflammatory bowel disease; ileus; genetic fructose intolerance
* Patients who received adjuvant chemotherapy and the duration from the last therapy less than 6 months
* Receive previously radiotherapy in measurable regions
* Pregnancy or lactating status
* Concurrent malignancy other than nonmelanoma skin cancer, or in situ cervix carcinoma
* Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months
* Acute or subacute intestinal occlusion or history of the inflammatory bowel disease
* Any factors that influence the usage of oral administration

Primary outcomes:
measure: objective response
timeFrame: 6 weeks
Secondary outcomes:
measure: progression free survival (PFS)
timeFrame: From randomization until first documented progression or date of death from any cause, whichever came first (up to 60 months)
Other outcomes:
measure: overall survival(OS)
timeFrame: from the date of randomization until the date of death from any cause, assessed up to 60 months
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jin Li, M.D / Ph.D
role: PRINCIPAL_INVESTIGATOR
References: