Compare Different Response Evaluations to Neoadjuvant Chemotherapy for Gastric Cancer
NCT ID: NCT02179463
Last Updated: 2014-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2014-06-30
2017-12-31
Brief Summary
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PURPOSE: Compare different pattern of response evaluation for Gastric Cancer.
Detailed Description
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OUTLINE: Neoadjuvant chemotherapy.
PROJECTED ACCRUAL: Up to 150 patients will be accrued over approximately 2 years.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Neoadjuvant Chemotherapy
undergo neoadjuvant chemotherapy before surgery
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Peking University
OTHER
Responsible Party
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Jiafu Ji
Professor
Principal Investigators
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Jiafu Ji, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University
Locations
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Peking Unicersity Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jiafu Ji, MD
Role: primary
Other Identifiers
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D141100000414004
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
KW-NeoCT-Evaluation-2014
Identifier Type: -
Identifier Source: org_study_id