RecruitingPhase 3NCT06706401

Lymphocyte-Sparing And Radio-Immunotherapy in Head and Neck Carcinoma

A Multicenter, Randomised 2*2 Factorial Design Comparing Standard to Reduced-target Volume Radiotherapy With or Without All-trans Retinoic Acid (ATRA) in Patients With Lateralised Oropharyngeal, Laryngeal and Hypopharyngeal Squamous Cell Carcinoma.

Sponsor

Centre Leon Berard

Enrollment

460 participants

Start Date

Feb 20, 2025

Study Type

INTERVENTIONAL

Conditions

Oropharynx Cancer Larynx Cancer Hypopharynx Cancer Primary Head and Neck Tumor

Summary

The aim of this study is to investigate the effect of ATRA (Vesanoid) and the effect of tailored radiotherapy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a radiation technique that deliberately protects the immune cells (lymphocytes) circulating in the blood while treating head and neck cancers, then combining this approach with immunotherapy to see if it improves outcomes. **You may be eligible if...** - You are 18 or older - You have a confirmed squamous cell carcinoma of the head and neck (oropharynx, larynx, or hypopharynx) that has not been treated before - Your cancer is on one side only and has not crossed to the other side of the neck - Imaging (PET/CT scan) shows no cancer spread to the opposite side - You are eligible for radiation therapy with or without chemotherapy - You are in good physical condition (ECOG 0-1) **You may NOT be eligible if...** - Your cancer has spread to both sides of the neck or to distant organs - You have received prior treatment for this head and neck cancer - Your overall health would make the combination treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVesanoid

Before (chemo)radiotherapy: D1 to D3: 150mg/m2/day, 1 week before radiotherapy. Post (chemo)radiotherapy: D1 to D3: 150mg/m2/day every 3 weeks for up to 4 cycles post (chemo)radiotherapy

RADIATIONStandard radiotherapy

70 Gy in 35 fractions of 2 Gy over 6 (6 fractions per week) or hyperfractionated RT with a median therapeutic dose of 80.5 Gy delivered in 70 fractions of 1.15 Gy over 7 weeks.

RADIATIONTailored radiotherapy

70 Gy in 35 fractions of 2 Gy over 6 weeks (6 fractions per week) or hyperfractionated RT with a median therapeutic dose of 80.5 Gy delivered in 70 fractions of 1.15 Gy over 7 weeks.

DRUGCisplatin

Cisplatin is recommended for the following patients : Stage T1-T2/N2a-N2b and T3/N0-N1-N2a-N2b. concomitant chemotherapy is standard of care treatments and should be administered as per standard practice. Chemotherapy will include one of the two cisplatin regimens specified in this protocol at the discretion of the participating centers. The centers must however treat all their recruited patients with one of the two regimens chosen before site activation. Chemotherapy should start the first day of radiotherapy. Cisplatin should be infused before radiation therapy delivery. The 2 options are: • Cisplatin 100 mg/m² i.v. on day 1 and 22 of radiotherapy (when 70 Gy are delivered in 6 weeks) or on day 1, 22 and 43 (when 70 Gy are delivered in 7 weeks). or • Cisplatin 40 mg/m² i.v. on day 1, 8, 15, 22, 29, 35 of radiotherapy (when 70 Gy are delivered in 6 weeks) or on day 1, 8, 15, 22, 29, 35, 42 of radiotherapy (when 70 Gy are delivered in 7 weeks).

DRUGCetuximab

Cetuximab is recommended for the following patients : Stage T1-T2/N2a-N2b and T3/N0-N1-N2a-N2b. concomitant Cetuximab is standard of care treatments and should be administered as per standard practice. Cetuximab therapy will be started with an intravenous loading dose of 400 mg/m2 one week before start of RT followed by six (radiotherapy over 6 weeks) or seven (radiotherapy over 7 weeks) weekly doses of 250 mg/m2.