Study of Hypo-fractionated Neoadjuvant Radiotherapy for Locally Advanced Gastric Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Gastric Cancer

Chemoradiation

Treatments

Radiation: Hypo-fractionated radiotherapy

Drug: S1

Study type

Interventional

Funder types

Other

Identifiers

NCT03427684

CAMS-GIRO-G005

Details and patient eligibility

About

Gastric cancer is one of the most common malignant tumors in China, and the incidence and mortality rate are second in malignant tumors. The treatment of gastric cancer need integrated multidisciplinary treatment, and surgery is the only possible curative method for gastric cancer at present. Previous studies have reported that neoadjuvant chemoradiotherapy can downstage primary tumor to increase radical resection rate in order to improve the long-term prognosis of advanced gastric cancer. However, there is no study on the application of hypo-radiotherapy to neoadjuvant radiotherapy in gastric cancer. The aim of this study was to observe the maximum tolerated dose (MTD) and dose limited toxicity (DLT) of hypo-fractionated radiotherapy for locally advanced gastric cancer.

Full description

After enrolled in this study, the patient was first treated with radiotherapy, concurrent with oral S-1 80mg/m2/day, on radiotherapy days. 3 weeks after the end of radiotherapy, patients treated with neoadjuvant chemotherapy with oxaliplatin and S-1. Oxaliplatin is given on dose of 130mg/m2 iv on day 1; S-1 on 40-60mg po BID on day 1-14, oral. Imaging evaluation was performed 3 weeks after neoadjuvant treatment. The radical operation and surgical procedure were determined on MDT discussion. Non-operable patients continue with 3 cycles of chemotherapy, and the chemotherapy regimen can be changed. A 3 cycle of SOX adjuvant chemotherapy was performed after surgery.

Enrollment

18 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical stage T3-4N+M0
Gastric cancer or Siewert II/III esophagogastric junction carcinoma;
Pathologically confirmed adenocarcinoma;
18-75 years old, male or female;
Karnofsky score >= 70;
White blood cell count >= 4 x 109 / L; platelet count >= 100 x109/L; serum creatinine =< 1 x upper limit of normal, total bilirubin =< 1 x upper limit of normal, alanine aminotransferase and aspartate aminotransferase =< 2.5 x upper limit of normal, alkaline phosphatase =< 5 x upper limit of normal.

Exclusion criteria