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

Lung Cancer Clinical Trial

— i-RTCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03117946
• Other study ID #: API/2016/67
• Status: Recruiting
• Phase: N/A
• Start date: May 29, 2017
• Est. completion date: December 2022

Study information

• Verified date: July 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Olivier ADOTEVI, Pr
• Phone: +33370632212
• Email: olivier.adotevi[@]univ-fcomte.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer

Intervention

Other:
• Biological samples
blood and tumor tissue sample

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon
France	Centre Georges François LECLERC	Dijon
France	Hôpital Nord Franche-Comté	Montbéliard
France	Institut Jean Godinot	Reims

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor antigen specific T-cell responses	tumor antigen specific T-cell responses	up to 12 months after the end of radiochemotherapy
Secondary	monitoring of immune checkpoints, immune cell death, immune suppressive cells and T-cell polarisation	monitoring of immune checkpoints, immune cell death, immune suppressive cells and T-cell polarisation	up to 12 months after the end of radiochemotherapy
Secondary	Progression free survival	time interval between the date of initiation of treatment and the date of first progression (local, remote [extent of the disease by RECIST v1.1] second cancer) or death from any cause	date of first progression of the disease (within 2 year after the initiation of the treatment)]
Secondary	overall survival	time between the date of initiation of treatment and the date of death from any cause	date of death from any cause (within 2 years after the initiation of the treatment)
Secondary	Quality of life related to health measured by EORTC-QLQC30	Quality of life related to health measured by EORTC-QLQC30	from the inclusion to patient death, up to 1 year