Tumor Response in Hypofractionated Radiotherapy

• Conditions: Neoplasms

• Registration Number: NCT02854449
• Lead Sponsor: Peking University First Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-03
• Study Start: 2016-11
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-18
• Last Update Posted: 2018-04-20
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of immune cells	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China