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

February 8, 2018 updated by: LI Ning, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose AND Dose limited toxicity
Time Frame: From date of enrollment until one month after chemo-radiotherapy
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
Time Frame: From date of enrollment until surgery, assessed up to 2 months
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
Time Frame: From date of enrollment until the date of first documented progression or date of relapse, whichever came first, assessed up to 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

December 31, 2016

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

January 28, 2018

First Submitted That Met QC Criteria

February 8, 2018

First Posted (Actual)

February 9, 2018

Study Record Updates

Last Update Posted (Actual)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAMS-GIRO-G005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Clinical Trials on Hypo-fractionated radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe