Tumor Response in Hypofractionated Radiotherapy (TRHR)

April 18, 2018 updated by: Celia, Peking University First Hospital

Biomarkers of Tumor Response in Hypofractionated Radiotherapy

This study will follow-up different immune cell populations in the blood before, during and after high dose radiation therapy which should give new information of the efficacy of Local Hypofractionated Radiotherapy and a rationale for adjuvant immunotherapy.

Study Overview

Status

Unknown

Conditions

Detailed Description

  • Patient information and collection of a signed informed consent form
  • Clinical data collection

  • Blood samples of 5 mL:

    1. after registration, prior to the first fraction of radiotherapy
    2. during radiotherapy sessions
    3. one month, 3 months after the last radiotherapy session
  • Storage of the blood samples at ambient temperature
  • Transportation of the samples to the Institute of Biology of Lille (IBL) - CNRS UMR8161 for analysis
  • Destruction of the samples at the end of the analysis

Study Type

Observational

Enrollment (Anticipated)

30

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
        • Recruiting
        • Peking University First Hospital
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receive local hypofractionated radiotherapy

Description

Inclusion Criteria:

  • Patient requiring a hypofractionated irradiation;
  • pathologically confirmed Unspecified Adult Solid Tumor
  • Age ≥ 18 years old
  • KPS≥70
  • Signed written informed consent.

Exclusion Criteria:

  • Patient treated by chemotherapy, targeted or immunotherapy within 21 days before the first sampling,
  • Pregnant or breastfeeding woman,
  • Patient under guardianship or tutorship.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of immune cells
Time Frame: prior to the first fraction of radiotherapy;14(±2) days from the begining of RT; the day (±2) of the last radiotherapy sessions ;one month, 3 months after the last radiotherapy session
The primary endpoint is the change of the percentage of immune cells before, during and after radiotherapy
prior to the first fraction of radiotherapy;14(±2) days from the begining of RT; the day (±2) of the last radiotherapy sessions ;one month, 3 months after the last radiotherapy session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local control
Time Frame: 3 months
Local control of radiotherapy will be assessed based on Response Evaluation Criteria in Solid Tumors(RECIST)1.1
3 months
Acute and Late toxicities
Time Frame: 3 months
Acute and late toxicities will be assessed based on the common toxicity criteria for adverse events version 4.0 (CTCAEv4.0).
3 months

Collaborators and Investigators

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

Sponsor

Peking University First Hospital

Collaborators

Beijing Tongren Hospital

Investigators

  • Study Chair: Gao Xianshu, Master, Peking University First Hospital

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)

November 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Actual)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20161022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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