Actively Recruiting
Lymphocyte-Sparing And Radio-Immunotherapy in Head and Neck Carcinoma
Led by Centre Leon Berard · Updated on 2026-04-24
460
Participants Needed
8
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lymphocyte-Sparing And Radio-Immunotherapy in Head and Neck Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older at consent
- Primary head and neck tumor on one side only, untreated, with histologically confirmed squamous cell carcinoma of the oropharynx p16-, larynx, or hypopharynx: T1/N2a-N2b, T2/N0-N2b, T3/N0-N2b (UICC 8th Ed.)
- For oropharynx p16+: T1/N1 (multiple nodes), T2-T3/N0-N1 (UICC 8th Ed.)
- Lymph node staging by FDG-PET/CT showing no nodal uptake on the opposite side
- Suitable for radiotherapy or chemo-radiotherapy as decided by the doctor
- ECOG Performance Status 0 or 1
- Adequate blood counts and organ function within 7 days before randomisation
- QTcF interval ≤450ms for men and ≤470ms for women on screening ECGs
- Women of child-bearing potential must have a negative pregnancy test and agree to use contraception during and for 1 month after treatment
- Fertile men must agree to use effective contraception during and for 1 month after treatment
- Able to understand and consent to the study and comply with visits
- Covered by medical insurance where applicable
You will not qualify if you...
- Primary tumor crossing the midline or bilateral primary tumors
- Certain tumor stages excluded: T1-N0 (p16-), T1-N1 (p16-), T1-N0 (p16+), T4 (both p16- and p16+), bilateral lymph nodes, or nodal disease >6 cm
- Unknown primary tumor size (T0-N1 to T0-N3)
- Nodal uptake on the opposite side detected by FDG-PET/CT
- Prior anti-cancer therapy for head and neck squamous cell carcinoma
- Other malignancies within 3 years except treated carcinoma in situ of cervix, skin cancers, or localized prostate cancer
- Need for systemic immunosuppressive or immunostimulatory medications (with some corticosteroid exceptions)
- Concurrent other anti-cancer treatments or participation in other therapeutic trials
- Severe infections within 4 weeks before randomisation or active hepatitis B, hepatitis C (if RNA positive), HIV, or active tuberculosis
- Psychological, cognitive, social, or geographic conditions that may prevent compliance
- Known allergies to tretinoin, retinoids, soya, peanut, or Vesanoid ingredients
- Malabsorption syndrome or inability to swallow oral medication
- Need for concurrent treatment with vitamin A, tetracyclines, other retinoids, anti-fibrinolytic agents, or strong CYP3A4 modifiers
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
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
Research Team
V
Vincent Grégoire, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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