NCT03427684

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Gastric Cancer
• Chemoradiation

Interventions

Type	Name	Description
RADIATION	Hypo-fractionated radiotherapy	Hypo-fractionated radiotherapy with fraction \>2Gy .
DRUG	S1	S-1 80mg/m2/day, orally intake on radiotherapy days.

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-12-31
• Completion: 2020-12-31
• First posted: 2018-02-09
• Last updated: 2018-02-09

Locations

1 site across 1 country: China