A Phase II Trial of Exploring the Predictive Factors of TX and XELOX Regimen in the First Line Treatment of MGC

NCT ID: NCT01963702

Last Updated: 2013-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-12-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Docetaxol ＆Capecitabine (TX)

Docetaxol: 75 mg/m2 d1, (From MAY 15th 2013, the dose was reduced to 60mg/m2 for high incidence of G3/4 myelosuppression after approved by institute Ethics Committee) ; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles

Group Type: EXPERIMENTAL

Docetaxol

Intervention Type: DRUG

Capecitabine

Intervention Type: DRUG

Oxaliplatin ＆Capecitabine (XELOX)

Oxaliplatin: 130 mg/m2 d1; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles

Group Type: ACTIVE_COMPARATOR

Oxaliplatin

Intervention Type: DRUG

Capecitabine

Intervention Type: DRUG

Interventions

Docetaxol

Intervention Type: DRUG

Oxaliplatin

Intervention Type: DRUG

Capecitabine

Intervention Type: DRUG

Other Intervention Names

xeloda

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xiaodong Zhu

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin Li, M.D / Ph.D

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

xiaodong Zhu, M.D

Role: CONTACT

xddr001@163.com

+862164175590 ext. 5000

Facility Contacts

xiaodong Zhu, M.D

Role: primary

xddr001@163.com

+862164175590 ext. 5000

Other Identifiers

FDZL-TXELOX

Identifier Type: -

Identifier Source: org_study_id