Compare Different Response Evaluations to Neoadjuvant Chemotherapy for Gastric Cancer

• Conditions: Gastric Cancer

• Registration Number: NCT02179463
• Lead Sponsor: Peking University

Brief Summary

RATIONALE: Neoadjuvant chemotherapy has been proved effective for locally advanced gastric cancer, yet the best pattern of response evaluation remain unknown.

PURPOSE: Compare different pattern of response evaluation for Gastric Cancer.

Detailed Description

OBJECTIVES: I. Find the best pattern for response evaluation for gastric cancer. II. Assess the factor associated with this pattern.

OUTLINE: Neoadjuvant chemotherapy.

PROJECTED ACCRUAL: Up to 150 patients will be accrued over approximately 2 years.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-21
• Study First Submitted QC: 2014-06-29
• Study First Posted: 2014-07-01
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-06
• Last Update Posted: 2014-12-09
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• sign written informed consent form
• age ≥ 18 years
• pathologically confirmed gastric or GEJ adenocarcinoma
• disease at clinical stage of locally advanced gastric cancer by CT/EUS(cT2+NanyM0)
• No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy
• Adequate organ function as defined below:

Hematologic ANC ≥ 1.5*109/l Hemoglobin ≥ 9 g/dl Platelets ≥ 100*109/l Hepatic Albumin ≥ 30g/l Serum bilirubin ≤ 1.5×ULN AST and ALT ≤ 2.5×ULN ALP ≤ 2.5×ULN TBIL ≤ 1.5×ULN Renal Serum Creatinine < 1.5 ULN

• KPS ≥ 70
• Adequate lung and heart function
• Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women
• Sexually active males or females willing to practice contraception during the study until 30 days after end of study.

Exclusion Criteria

• Refuse to provide blood/tissue sample；
• With distant metastasis diagnosed by CT/EUS；
• Sexually active males or females refuse to practice contraception during the study until 30 days after end of study.
• History of organ transplantation（including autologous bone marrow transplantation and Peripheral stem cell transplantation）；
• Prior long term steroid therapy (excluding short term steroid treatment which is completed prior to > 2 weeks of study enrollment)；
• Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease；
• Concurrent severe infection；
• Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety (including current active hepatic, biliary, renal, respiratory disease, uncontrolled diabetes hypertension et al)；
• History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible；
• Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, or congestive heart failure, or cardiac infarction within 6 months prior to study enrollment, or cardiac insufficiency；
• Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathological Response	7days

Secondary Outcome Measures

Name	Time	Method
downstage proportion	7days	compared pathological stage with initial clinical stage, define T downstage or N downstage as downstage

Trial Locations

Locations (1)

Peking Unicersity Cancer Hospital; 🇨🇳 Beijing, Beijing, China