Status:
UNKNOWN
A Phase II Study of Total Neoadjuvant Therapy for Locally Advanced Gastric Cancer
Lead Sponsor:
Jing Jin, M.D.
Collaborating Sponsors:
Beijing Hope Run
Conditions:
Gastric Cancer
Neoadjuvant Therapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This prospective, single arm phase II study is designed to evaluate the rate of pathologic complete response of neoadjuvant chemoradiotherapy and neoadjuvant chemotherapy followed by surgery for local...
Eligibility Criteria
Inclusion
- Histologically or cytologically proven locally advanced gastric adenocarcinoma in patients staged as cT3-4N+M0
- No distant metastasis in liver,lung,bone,central nervous system(CNS),no peritoneal transplantation
- No prior abdominal or pelvic radiotherapy
- Karnofsky performance status(KPS)≥ 70, predictive life span no less than 6 months
- Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,000 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
- Informed consent
Exclusion
- Any prior chemotherapy or other cancer treatment prior to this protocol
- Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
- With any distant metastasis in liver,lung,bone,CNS,or peritoneal transplantation
- History of allergic reactions attributed to similar chemical or biologic complex to S-1 or Xeloda or Oxaliplatin
- Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
- History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
- History of prior radiation to the abdomen
- Pregnant or lactating females
Key Trial Info
Start Date :
November 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 21 2023
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04062058
Start Date
November 20 2019
End Date
September 21 2023
Last Update
January 24 2022
Active Locations (1)
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1
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, China, 100021