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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02439008
• Other study ID #: EarlyBio-HypoRT-WP3-1504
• Status: Terminated
• Phase: N/A
• Start date: September 16, 2015
• Est. completion date: March 18, 2019

Study information

• Verified date: May 2019
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: March 18, 2019
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Colorectal Neoplasms
• Kidney Neoplasms
• Melanoma
• Neoplasms

Intervention

Procedure:
• Blood samples collection before radiotherapy
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 during radiotherapy
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 after radiotherapy
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.

Radiation:
• Radiotherapy

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Institut de Biologie de Lille

Country where clinical trial is conducted

France, 

Outcome

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