A Phase III Trial of Preoperative or Postoperative Chemoradiation Therapy for Potentially Resectable Adenocarcinoma of Stomach Cancer

Sichuan Provincial People's Hospital3 sites in 1 country450 target enrollmentSeptember 2016

Overview

Based upon RTOG 9904, this study is to investigate the role of preoperative chemo and chemoradiation for locally advanced gastric cancer.

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

October 2021

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Sichuan Provincial People's Hospital

Responsible Party

Principal Investigator

ming zeng, MD

Director of Cancer Center

Sichuan Provincial People's Hospital

•Patients with potentially resectable adenocarcinoma of the stomach with histologic proof.
•EUS or MRI stage T3-4, any N, M
•Adequate bone marrow (defined as peripheral absolute granulocyte count of \> 2,000/μL, and platelet count of\>100,000/μL), liver (bilirubin \< 1.5 mg/dl), and renal functions (creatinine \< 1.5 mg/dl).
•Absence of peritoneal disease by laparoscopic staging; no positive cytology of pleural, or pericardial effusion.
•No prior major surgery or radiotherapy to the stomach, or immunotherapy or chemotherapy for any reason.
•Patients must have a life expectancy of at least 16 weeks.
•Performance status of \< 2 (Zubrod scale).
•No biopsy proof of lymph node metastases outside the study field.
•No evidence of metastatic disease to distant organs.
•No presence of concurrent or previous malignancies \< 5 years, other than noninvasive skin cancer.

•Evidence of metastatic disease
•Prior chemotherapy or radiotherapy
•Patients with a past history of cancer
•Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled
•Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures
•Cardiac failure or Sever Pulmonary disease
•Patients with impaired gastrointestinal absorption for whatever reason
•Patients medically unfit for cisplatin or taxol chemotherapy