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

NCT02439008 | Terminated

• 2 other identifiers: EarlyBio-HypoRT-WP3-15042015-A00246-43
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Hepatocellular; Melanoma; Colorectal Neoplasms; Kidney Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  from baseline to 1 year follow up

Secondary Outcomes (3)

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

  from baseline to 1 year follow up

• Progression-free rate

  from baseline to 1 year follow up

• Number of Participants with Adverse Events related to radiotherapy

  from baseline to 1 year follow up

Study Arms (1)

Blood samples collection

EXPERIMENTAL

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)

Procedure: Blood samples collection before radiotherapy; Procedure: Blood samples collection during radiotherapy; Procedure: Blood samples collection after radiotherapy; Radiation: Radiotherapy

Interventions

Blood samples collection before radiotherapy PROCEDURE

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

Blood samples collection

Blood samples collection during radiotherapy PROCEDURE

* 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

Blood samples collection

Blood samples collection after radiotherapy PROCEDURE

* 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.

Blood samples collection

Radiotherapy RADIATION

Blood samples collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Oscar Lambret: lead
• Institut de Biologie de Lille: collaborator

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Colorectal Neoplasms; Melanoma; Kidney Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Xavier Mirabel, MD

  Centre Oscar Lambret

  STUDY DIRECTOR

• Nadira Delhem, MD

  Institut de Biologie de Lille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: May 8, 2015
• Study Start: September 16, 2015
• Primary Completion: June 21, 2018
• Study Completion: March 18, 2019
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

FR (1)