Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy (i-RTCT)

Centre Hospitalier Universitaire de Besancon

Status: Enrolling

Conditions: Lung Cancer; Head and Neck Cancer

Treatments: Other: Biological samples

Study type: Interventional

Funder types: Other

Identifiers

NCT03117946

API/2016/67

Details and patient eligibility

About

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

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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220 participants in 1 patient group

Biological samples

Experimental group

Description:

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.

Treatment:

Other: Biological samples