Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy

NCT ID: NCT03117946

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-29

Study Completion Date

2026-11-29

Brief Summary

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The aim of this study is to evaluate modulation of anti-tumor T cell responses in cancer patients treated by concomitant radiochemotherapy (i-RTCT)

Detailed Description

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Conditions

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Lung Cancer Head and Neck Cancer

Keywords

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immunomonitoring immune checkpoint chemoradiation T cells

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Biological samples

Blood samples will be collected at baseline, at J15/J20 after RTCT initiation, and then 1 month, 3 months and 12 months after the end of RTCT treatment, and at disease progression if applicable.

Tumor tissues will be collected if available.

Group Type EXPERIMENTAL

Biological samples

Intervention Type OTHER

blood and tumor tissue sample

Interventions

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Biological samples

blood and tumor tissue sample

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed NSCLC (Non Small Cell Lung Cancer) or SCLC (small cell lung cancer) OR histologically confirmed Head and neck cancer
* Patient candidate to a first-line concomitant radiochemotherapy
* Written informed consent

Exclusion Criteria

* Sequential radiochemotherapy, exclusive radiotherapy, or stereotactic radiotherapy
* History of adjuvant radiochemotherapy for cancer treatment
* Patients under immunotherapy, chemotherapy or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
* HIV, hepatitis C or B virus
* Patients with any medical or psychiatric condition or disease,
* Patients under guardianship, curatorship or under the protection of justice.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Besançon

Besançon, , France

Site Status RECRUITING

Centre Georges François LECLERC

Dijon, , France

Site Status RECRUITING

Hôpital Nord Franche-Comté

Montbéliard, , France

Site Status RECRUITING

Institut Jean Godinot

Reims, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Olivier ADOTEVI, Pr

Role: CONTACT

Phone: +33370632212

Email: [email protected]

Facility Contacts

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Sophie Depierre

Role: primary

Etienne MARTIN, Dr

Role: primary

SUN, Dr

Role: primary

Stéphanie SERVAGI VERNAT, Dr

Role: primary

Other Identifiers

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API/2016/67

Identifier Type: -

Identifier Source: org_study_id