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

Primary Purpose

Carcinoma, Hepatocellular, Colorectal Neoplasms, Melanoma

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Blood samples collection before radiotherapy

Blood samples collection during radiotherapy

Blood samples collection after radiotherapy

Radiotherapy

About this trial

This is an interventional basic science trial for Carcinoma, Hepatocellular focused on measuring liver metastases of colorectal cancer, metastases of melanoma or renal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Centre Oscar Lambret

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blood samples collection

Arm Description

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)

Outcomes

Primary Outcome Measures

Analyse of immunological parameters, decription of secreted markers and nanovesicles production

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

Cell viability, determined by number of live/dead cells present

Cell viability and cell proliferation

Progression-free rate

progression-free rate at 12 months

Number of Participants with Adverse Events related to radiotherapy

adverse effects (acute toxicity) according to CTCAE-NCI

Full Information

NCT ID

NCT02439008

First Posted

April 27, 2015

Last Updated

May 21, 2019

Sponsor

Centre Oscar Lambret

Collaborators

Institut de Biologie de Lille

1. Study Identification

Unique Protocol Identification Number

NCT02439008

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Terminated

Why Stopped

Lack of patient enrollment

Study Start Date

September 16, 2015 (Actual)

Primary Completion Date

June 21, 2018 (Actual)

Study Completion Date

March 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Oscar Lambret

Collaborators

Institut de Biologie de Lille

4. Oversight

Data Monitoring Committee

5. Study Description

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: after registration, prior to the first fraction of radiotherapy within 15 minutes after the administration of the 1st, the 2nd and the 3rd radiotherapy sessions 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Hepatocellular, Colorectal Neoplasms, Melanoma, Kidney Neoplasms

Keywords

liver metastases of colorectal cancer, metastases of melanoma or renal cancer

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Blood samples collection

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Blood samples collection before radiotherapy

Intervention Description

Nine blood samples (35 mL each) will be collected in each patient before, during and after radiotherapy treatment. Before radiotherapy: Sample T0: after registration, in the days running up to the administration of the first fraction of radiotherapy

Intervention Type

Procedure

Intervention Name(s)

Blood samples collection during radiotherapy

Intervention Description

Sample T1: within 15 minutes after the administration of the first fraction, Sample T2: within 15 minutes after the administration of the second fraction, Sample T3: within 15 minutes after the administration of the third fraction

Intervention Type

Procedure

Intervention Name(s)

Blood samples collection after radiotherapy

Intervention Description

Sample T4: one week after the end of the radiotherapy, Samples T5 to T8: respectively 3 months, six months, 9 months and 12 months after the end of the radiotherapy.

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Primary Outcome Measure Information:

Title

Analyse of immunological parameters, decription of secreted markers and nanovesicles production

Description

Time Frame

from baseline to 1 year follow up

Secondary Outcome Measure Information:

Title

Cell viability, determined by number of live/dead cells present

Description

Cell viability and cell proliferation

Time Frame

from baseline to 1 year follow up

Title

Progression-free rate

Description

progression-free rate at 12 months

Time Frame

from baseline to 1 year follow up

Title

Number of Participants with Adverse Events related to radiotherapy

Description

adverse effects (acute toxicity) according to CTCAE-NCI

Time Frame

from baseline to 1 year follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xavier Mirabel, MD

Organizational Affiliation

Centre Oscar Lambret

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Nadira Delhem, MD

Organizational Affiliation

Institut de Biologie de Lille

Official's Role

Study Director

Facility Information:

Facility Name

Centre Oscar Lambret

City

Lille

ZIP/Postal Code

59020

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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