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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastric Cancer, Chemoradiation

Intervention / Treatment
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* Radiation: Hypo-fractionated radiotherapy
* Drug: S1


Participation Criteria
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Eligibility Criteria
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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: Any chemotherapy or radiotherapy history before enrollment Siewert I EGJ cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypo-fractionated radiotherapy<br>Hypo-fractionated neoadjuvant radiotherapy concurrent with S1 chemotherapy for local advanced gastric cancer | Radiation: Hypo-fractionated radiotherapy<br>* Hypo-fractionated radiotherapy with fraction >2Gy .<br>Drug: S1<br>* S-1 80mg/m2/day, orally intake on radiotherapy days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose AND Dose limited toxicity | To assess maximum tolerated dose and dose limited toxicity of hypo-fractionated neoadjuvant radiotherapy | From date of enrollment until one month after chemo-radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | To evaluate the pathological response rate of gastric cancer after hypo-fractionated neoadjuvant radiotherapy | From date of enrollment until surgery, assessed up to 2 months | 
| 2-year disease-free survival | To evaluate the 2-year disease-free survival of gastric cancer after hypo-fractionated neoadjuvant radiotherapy | From date of enrollment until the date of first documented progression or date of relapse, whichever came first, assessed up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer, Chemo-radiotherapy, Phase I study, Hypo-fractionated radiotherapy