Actively Recruiting
Led by Centre Leon Berard · Updated on 2026-04-24
460
Participants Needed
8
Research Sites
N/A
Total Duration
Researchers are studying patients with squamous cell carcinoma of the oropharynx, larynx, or hypopharynx to evaluate the effects of all-trans retinoic acid (ATRA, Vesanoid) and tailored radiotherapy. This phase III trial aims to see if these treatments reduce severe lymphopenia and immune aging, potentially improving event-free survival at two years compared to standard radiotherapy alone. The study targets patients with lateralized tumors who have not received prior treatment for this cancer. Participants are randomly assigned to one of four groups: standard radiotherapy with follow-up; tailored radiotherapy combined with ATRA; standard radiotherapy combined with ATRA; or tailored radiotherapy with follow-up. Radiotherapy lasts 6 to 8 weeks, delivered as standard or tailored doses, often alongside standard chemotherapy with cisplatin or cetuximab. ATRA is taken orally before and after radiotherapy in specified cycles for assigned groups. After treatment, patients are followed for disease progression, survival, or withdrawal. During the study, patients undergo regular assessments including event-free survival evaluations at multiple intervals up to two years, monitoring for relapse, metastasis, survival, adverse events, and quality of life using several questionnaires. Immunomonitoring is performed at key points during treatment. Researchers also analyze health economics and lymph node status. Safety and patient well-being are closely tracked throughout the study duration, which may last until 2029 or until specified endpoints occur.
CONDITIONS
Lymphocyte-Sparing And Radio-Immunotherapy in Head and Neck Carcinoma
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 8 weeks plus up to 12 weeks of additional Vesanoid cycles if assigned
Participants receive 6 to 8 weeks of standard or tailored radiotherapy with or without the drug Vesanoid (ATRA). Participants may also receive cisplatin or cetuximab as part of standard care chemotherapy during radiotherapy. Vesanoid is given orally for 3 days starting 1 week before radiotherapy and for up to 4 cycles every 3 weeks after radiotherapy for those assigned to receive it.
Daily visits during radiotherapy and 1 visit every 3 weeks for up to 4 cycles of Vesanoid after radiotherapy (if applicable)
Duration - Up to 2 years
Participants are monitored after treatment until disease progression, death, withdrawal of consent, or end of trial, with assessments of event-free survival and quality of life up to 2 years.
Visits at 6, 9, 15, 21, and 27 months after randomization, then annually up to 2 years
Total: 8 locations
1
Centre Léon Bérard
Lyon, France, France, 69008
Actively Recruiting
2
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, France, 54519
Actively Recruiting
3
Institut Gustave Roussy
Villejuif, France, France, 94805
Actively Recruiting
4
Institut de Cancérologie de l'Ouest - Paul Papin
Angers, France, 49055
Actively Recruiting
5
Centre Oscar Lambret
Lille, France, 59000
Actively Recruiting
6
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
7
AP-HP - Hôpital Tenon
Paris, France, 75020
Actively Recruiting
8
Institut Godinot
Reims, France
Actively Recruiting
V
Vincent Grégoire, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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Max Gau, Fatimah A Alfaraj, Shao Hui Huang...
https://pubmed.ncbi.nlm.nih.gov/40692081