Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 : Immune Response

Not Applicable

Terminated

• Conditions: Kidney Neoplasms; Colorectal Neoplasms; Carcinoma, Hepatocellular; Melanoma
• Interventions: Procedure: Blood samples collection before radiotherapy; Procedure: Blood samples collection during radiotherapy; Procedure: Blood samples collection after radiotherapy; Radiation: Radiotherapy

• Registration Number: NCT02439008
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

This study will follow-up immune cell populations, secreted factors and released nanovesicles in the blood before, during and after high dose radiation therapy which should give new information of the efficacy of the hypofractionated high dose radiation therapy and a rationale for adjuvant immunotherapy.

Detailed Description

* Patient information and collection of a signed informed consent form

* Clinical data collection

* Blood samples of 35 mL:

1. after registration, prior to the first fraction of radiotherapy

2. within 15 minutes after the administration of the 1st, the 2nd and the 3rd radiotherapy sessions

3. one week, 3 months, 6 months, 9 months and 12 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: 2015-04-27
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-08
• Study Start: 2015-09-16
• Primary Completion: 2018-06-21
• Study Completion: 2019-03-18
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Patient requiring a hypofractionated irradiation (≥ 3 fractions, dose ≥ 9 Gy per fraction) either for :
• hepatocellular carcinoma or hepatic lesion of metastatic Colorectal Cancer,
• metastasis from melanoma or renal cancer,
• Age ≥ 18 years old,
• Registered with a social security system,
• 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: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood samples collection	Blood samples collection after radiotherapy	Nine blood samples will be collected in each patient before, during and after radiotherapy treatment. Interventions : * Blood samples collection before radiotherapy (T0) * Blood samples collection during radiotherapy (T1-T3) * Blood samples collection after radiotherapy (T4-T8)
Blood samples collection	Radiotherapy	Nine blood samples will be collected in each patient before, during and after radiotherapy treatment. Interventions : * Blood samples collection before radiotherapy (T0) * Blood samples collection during radiotherapy (T1-T3) * Blood samples collection after radiotherapy (T4-T8)
Blood samples collection	Blood samples collection during radiotherapy	Nine blood samples will be collected in each patient before, during and after radiotherapy treatment. Interventions : * Blood samples collection before radiotherapy (T0) * Blood samples collection during radiotherapy (T1-T3) * Blood samples collection after radiotherapy (T4-T8)
Blood samples collection	Blood samples collection before radiotherapy	Nine blood samples will be collected in each patient before, during and after radiotherapy treatment. Interventions : * Blood samples collection before radiotherapy (T0) * Blood samples collection during radiotherapy (T1-T3) * Blood samples collection after radiotherapy (T4-T8)

Primary Outcome Measures

Name	Time	Method
Analyse of immunological parameters, decription of secreted markers and nanovesicles production	from baseline to 1 year follow up	Description and evolution of cell fraction, quantification of immune cells, verification of the presence and evolution of activation markers and quantification of secreted exosomes ; before, during and after radiotherapy

Secondary Outcome Measures

Name	Time	Method
Progression-free rate	from baseline to 1 year follow up	progression-free rate at 12 months
Number of Participants with Adverse Events related to radiotherapy	from baseline to 1 year follow up	adverse effects (acute toxicity) according to CTCAE-NCI
Cell viability, determined by number of live/dead cells present	from baseline to 1 year follow up	Cell viability and cell proliferation

Trial Locations

Locations (1)

Centre Oscar Lambret; 🇫🇷 Lille, France