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

Centre Oscar Lambret

Status: Terminated

Conditions: Melanoma; Carcinoma, Hepatocellular; Kidney Neoplasms; Colorectal Neoplasms

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02439008

EarlyBio-HypoRT-WP3-1504

Details and patient eligibility

About

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.

Full 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

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

28 participants in 1 patient group

Blood samples collection

Experimental group

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)

Treatment:

Radiation: Radiotherapy

Procedure: Blood samples collection before radiotherapy

Procedure: Blood samples collection after radiotherapy

Procedure: Blood samples collection during radiotherapy