To hear about similar clinical trials, please enter your email below
Trial Title:
Compare Different Response Evaluations to Neoadjuvant Chemotherapy for Gastric Cancer
NCT ID:
NCT02179463
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Gastric Cancer
Neoadjuvant chemotherapy
Response Evaluation
Study type:
Observational [Patient Registry]
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Locally advanced Gastric Cancer(cT2-4NanyM0)，estimated to do neoadjuvant chemotherapy
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Unicersity Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiafu Ji, MD
Phone:
0086-10-88196391
Email:
jiafuj@hotmail.com
Start date:
June 2014
Completion date:
December 2017
Lead sponsor:
Agency:
Peking University
Agency class:
Other
Source:
Peking University
Record processing date:
ClinicalTrials.gov processed this data on April 10, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02179463
