Lymphocyte-Sparing And Radio-Immunotherapy in Head and Neck Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Leon Berard
About this trial
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 criteria
Qualifiers
the oropharynx p16-, larynx or hypopharynx : T1/N2a-N2b, T2/N0-N2b, T3/N0-N2b (UICC 8th Ed.), or
the oropharynx p16+ : T1/N1 (multiple nodes), T2-T3/N0-N1 (UICC 8th Ed.).
Neutrophils count > 1.5 × 109 /L
Platelets count > 75 × 109 /L
Disqualifiers
Severe infection within 4 weeks prior to randomisation, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia,
Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening),
Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA at screening,
HIV infection,
Trial design
Treatments tested in this trial
- Vesanoid
- Standard radiotherapy
- Tailored radiotherapy
- Cisplatin
- Cetuximab
Treatment groups
460 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov