Tumor Response in Hypofractionated Radiotherapy

Biomarkers of Tumor Response in Hypofractionated Radiotherapy

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02854449

Acronym

TRHR

Enrollment

Registered

2016-08-03

Start date

2016-11-30

Completion date

2020-12-31

Last updated

2018-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Immune Marker, Immunologic Marker, Radiotherapy, Dose Hypofractionation

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

China

Contacts

Primary ContactBai Yun, Master

flkmy1@126.com

Outcome results