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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2020-12-31

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.

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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.

Conditions

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Gastric Cancer Chemoradiation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypo-fractionated radiotherapy

Hypo-fractionated neoadjuvant radiotherapy concurrent with S1 chemotherapy for local advanced gastric cancer

Group Type EXPERIMENTAL

Hypo-fractionated radiotherapy

Intervention Type RADIATION

Hypo-fractionated radiotherapy with fraction \>2Gy .

S1

Intervention Type DRUG

S-1 80mg/m2/day, orally intake on radiotherapy days.

Interventions

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Hypo-fractionated radiotherapy

Hypo-fractionated radiotherapy with fraction \>2Gy .

Intervention Type RADIATION

S1

S-1 80mg/m2/day, orally intake on radiotherapy days.

Intervention Type DRUG

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.