Modulating immune responses in lung and head/neck cancer patients undergoing combined treatment
Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy
This study is testing how a combined treatment of radiation and chemotherapy affects the immune system in patients with lung or head and neck cancer to see if it can help fight their tumors better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Besancon Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, prednisone |
| Locations | 4 sites (Besançon and 3 other locations) |
| Trial ID | NCT03117946 on ClinicalTrials.gov |
What this trial studies
This study evaluates how anti-tumor T cell responses are affected in patients with lung cancer or head and neck cancer who are receiving concomitant radiochemotherapy. By analyzing biological samples, the research aims to understand the immune modulation that occurs during this combined treatment approach. The goal is to enhance the effectiveness of the therapy by optimizing the immune response against tumors. Patients will be monitored for their immune responses throughout the treatment process.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed non-small cell lung cancer or small cell lung cancer, or head and neck cancer, who are eligible for first-line concomitant radiochemotherapy.
Not a fit: Patients who have received prior adjuvant radiochemotherapy or are currently undergoing immunotherapy or other immunosuppressive treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for patients with lung and head/neck cancers by enhancing their immune response to tumors.
How similar studies have performed: Other studies have shown promise in modulating immune responses in cancer patients undergoing similar treatments, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Besançon and 3 other locations
- CHU de Besançon — Besançon, France (Recruiting)
- Centre Georges François LECLERC — Dijon, France (Recruiting)
- Hôpital Nord Franche-Comté — Montbéliard, France (Recruiting)
- Institut Jean Godinot — Reims, France (Recruiting)
Study contacts
- Study coordinator: Olivier ADOTEVI, Pr
- Email: olivier.adotevi@univ-fcomte.fr
- Phone: +33370632212
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.