Compare Different Response Evaluations to Neoadjuvant Chemotherapy for Gastric Cancer

NCT02179463 | Unknown DMC

• 2 other identifiers: KW-NeoCT-Evaluation-2014D141100000414004
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

Gastric Cancer; Neoadjuvant chemotherapy; Response Evaluation

Outcome Measures

Primary Outcomes (1)

• Pathological Response

  7days

Secondary Outcomes (1)

• downstage proportion

  7days

Study Arms (1)

Neoadjuvant Chemotherapy

undergo neoadjuvant chemotherapy before surgery

Eligibility Criteria

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

Study Population

Locally advanced Gastric Cancer(cT2-4NanyM0)，estimated to do neoadjuvant chemotherapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking Unicersity Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tumor, Blood Sample

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

• Jiafu Ji, MD

  Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiafu Ji, MD

CONTACT

86-10-88196050; jiafuj@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 21, 2014
• First Posted: July 1, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

CN (1)