Lymphocyte-Sparing And Radio-Immunotherapy in Head and Neck Carcinoma (LYSARI)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Oropharynx Cancer; Larynx Cancer; Hypopharynx Cancer; Primary Head and Neck Tumor
• Intervention / Treatment: Radiation: Standard radiotherapy; Drug: Cisplatin; Drug: Cetuximab; Drug: Vesanoid; Radiation: Tailored radiotherapy

Detailed Description

Following validation of eligibility criteria, patients will be randomised (1:1:1:1) to receive:

• Arm A: Standard radiotherapy then follow-up
• Arm B: Tailored radiotherapy and ATRA (Vesanoid)
• Arm C: Standard radiotherapy and ATRA (Vesanoid)
• Arm D: Tailored radiotherapy then follow-up

This randomised phase III clinical trial will provide the clinical proof-of-concept that unilateral irradiation for lateralized tumors and the addition of ATRA (Vesanoid) to radiotherapy in HNSCC prevents severe lymphopenia and immunosenescence and therefore, may foster a radiation-induced anticancer immune response sufficient to increase event-free survival at 2 years.

• Study Type: Interventional
• Enrollment (Estimated): 460
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Vincent Grégoire, PhD; Phone Number: +33 4 69 85 62 53; Email: vincent.gregoire@lyon.unicancer.fr

Study Locations

• France
  • Angers, France, 49055
    • Recruiting
    • Institut de Cancérologie de l'Ouest - Paul Papin
    • Contact: Aurore Goineau, PhD; Phone Number: +33241352830; Email: aurore.goineau@ico.unicancer.fr
    • Principal Investigator: Aurore Goineau, PhD
  • Lille, France, 59000
    • Recruiting
    • Centre Oscar Lambret
    • Contact: Xavier Liem, PhD; Phone Number: +33320295911; Email: x-liem@o-lambret.fr
    • Principal Investigator: Xavier Liem, PhD
  • Nice, France, 06189
    • Recruiting
    • Centre Antoine Lacassagne
    • Contact: Deborah Aloi, PhD; Phone Number: +33492031000; Email: deborah.aloi@nice.unicancer.fr
    • Principal Investigator: Deborah Aloi, PhD
  • Paris, France, 75020
    • Recruiting
    • AP-HP - Hopital Tenon
    • Contact: Florence Huguet, PhD; Phone Number: +33156016210; Email: florence.huguet@aphp.fr
    • Principal Investigator: Florence Huguet, PhD
  • Reims, France
    • Recruiting
    • Institut Godinot
    • Contact: Arnaud BEDDOCK, PhD; Phone Number: +33326504351; Email: arnaud.beddok@reims.unicancer.fr
    • Principal Investigator: Arnaud BEDDOCK, PhD
  • France
    • Lyon, France, France, 69008
      • Recruiting
      • Centre Léon Bérard
      • Contact: Vincent Grégoire, PhD; Phone Number: +33 4 69 85 62 53; Email: vincent.gregoire@lyon.unicancer.fr
      • Principal Investigator: Vincent Grégoire, PhD
    • Vandœuvre-lès-Nancy, France, France, 54519
      • Recruiting
      • Institut de Cancerologie de Lorraine
      • Contact: Maria JOLNEROVSKI, PhD; Phone Number: +33 83598423; Email: m.jolnerovski@nancy.unicancer.fr
      • Principal Investigator: Maria JOLNEROVSKI, PhD
    • Villejuif, France, France, 94805
      • Recruiting
      • Institut Gustave Roussy
      • Contact: Roger Sun, PhD; Phone Number: +33 1 42 11 25 16; Email: ROGER.SUN@gustaveroussy.fr
      • Principal Investigator: Roger Sun, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria :

I1. Male or female patients aged ≥ 18 years old at time of inform consent signature.

I2. Patients with primary head and neck tumour up to, but not crossing the midline, previously 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.), or
• the oropharynx p16+ : T1/N1 (multiple nodes), T2-T3/N0-N1 (UICC 8th Ed.).

I3. Patients with lymph node staging assessed by an FDG-PET/CT with no contralateral nodal uptake.

I4. Patients amenable to treatment with RT or concomitant chemo-radiotherapy as decided by the treating physician as a function of tumor stage, tumor location, performance of the patients.

I5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

I6. Adequate hematologic and end-organ function, defined by the following laboratory test results obtained within 7 days prior to randomisation :

Hematological (without transfusion within 2 weeks) :

• Neutrophils count > 1.5 × 109 /L
• Platelets count > 75 × 109 /L
• WBC≥ 3.0 × 109 /L

Hepatic function :

• Total Bilirubin < 1.5 × ULN (except for Gilbert's syndrome which will allow bilirubin ≤ 3 ULN).
• Alanine aminotransferase (ALT) ≤ 2.5 × ULN.
• Aspartate aminotransferase (AST) ≤ 2.5 × ULN.
• Albumin >3.0g/dL

Renal function :

• Serum creatinine < 1.5 ×ULN.

I7. QTcF ≤450ms for men and 470ms for women, from 3 electrocardiograms on screening ECG, within 7 days prior randomisation.

I8. Women patients of child-bearing potential are eligible, provided they have a negative serum or urine pregnancy test within 7 days prior randomisation, and agrees to use adequate contraception for up to 1 month after the end of study treatments.

I9. Fertile men must agree to use an effective method of contraception during the study and for up to 1 month after the end of study treatments.

I10. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed and should be able and willing to comply with study visits and procedures as per protocol.

I11. Patients must be covered by a medical insurance in country where applicable.

Exclusion criteria :

E1. Patient with primary tumor crossing the midline or patients with bilateral primary tumors.

E2. Patients with T1-N0 (p16-), T1-N1 (p16-), T1-N0 (p16+), T4 (p16- and p16+), bilateral lymph nodes or nodal disease more than 6 cm (p16- and p16+).

E3. Patients with unknown primary tumor size as per TNM i.e. T0-N1 to T0-N3, p16- or p16+.

E4. Patients with contralateral FDG-PET/CT nodal uptake.

E5. Patient with any previous anti-cancer therapy for HNSCC (all prior treatment are forbidden: chemotherapy, radiotherapy, targeted therapy, immunotherapy or any other therapy approved or experimental).

E6. Patient with malignancies other than HNSCC within 3 years prior to randomisation with the exception of adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localised prostate cancer treated surgically with curative intent.

E7. Patient with ongoing or anticipation of need for systemic immunosuppressive medication (including, but not limited to, glucocorticoids, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents); with the exceptions of intranasal, inhaled or topical corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.

E8. Patient with ongoing or anticipation of need for systemic immunostimulatory agents (including, but not limited to, interferons and IL-2).

E9. Patient with concurrent treatment with any other anti-cancer treatment, approved or investigational agent or participation in another clinical trial with therapeutic intent.

E10. Patient with infectious diseases :

• 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,
• Active tuberculosis.

E11.Patient with any psychological, cognitive, familial, sociological or geographical condition potentially hampering compliance with the study protocol, completion of patient reported measures and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

E12. Patient with known hypersensitivity to tretinoin, other retinoids, soya, peanut or to any of the excipients of vesanoid.

E13. Patient with known malabsorption syndrome and/or unable to swallow oral medication.

E14.Patient with ongoing or expected need for concomitant treatment with vitamin A, tetracyclines, other retinoids, anti-fibrinolytic agent, and strong inducers or inhibitors of CYP3A4.

E15.Pregnant or lactating woman.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard radiotherapy; Patient will receive 6 to 8 weeks of standard (chemo)radiotherapy then will be followed until document progression disease, death, withdrawal of consent or end of trial (whichever occurs first). In addition of radiotherapy, patient will receive cisplatin or cetuximab (standard of care treatments).	Radiation: Standard 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.; Drug: Cisplatin; 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).; Drug: Cetuximab; 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.
Experimental: Tailored radiotherapy and ATRA (Vesanoid); ATRA will be administered per os 1 week before the start of (chemo)radiotherapy (daily administration for 3 days). Then, patient will receive 6 to 8 weeks of tailored (chemo)radiotherapy. In addition of radiotherapy, patient will receive cisplatin or cetuximab (standard of care treatments). Subsequently, ATRA will be administered per os for 3 days every 3 weeks for a total of 4 courses starting 2 to 3 weeks after the end of (chemo)radiotherapy. Finally, the patient will be followed until document progression disease, death, withdrawal of consent or end of trial (whichever occurs first).	Drug: Cisplatin; 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).; Drug: Cetuximab; 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.; Drug: Vesanoid; 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; Other Names: ATRA; Radiation: Tailored 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.
Experimental: Standard radiotherapy and ATRA (Vesanoid); ATRA will be administered per os 1 week before the start of (chemo)radiotherapy (daily administration for 3 days). In addition of radiotherapy, patient will receive cisplatin or cetuximab (standard of care treatments).Then, patient will receive 6 to 8 weeks of standard (chemo)radiotherapy. Subsequently, ATRA will be administered per os for 3 days every 3 weeks for a total of 4 courses starting 2 to 3 weeks after the end of (chemo)radiotherapy. Finally, the patient will be followed until document progression disease, death, withdrawal of consent or end of trial (whichever occurs first).	Radiation: Standard 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.; Drug: Cisplatin; 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).; Drug: Cetuximab; 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.; Drug: Vesanoid; 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; Other Names: ATRA
Experimental: Tailored radiotherapy; Patient will receive 6 to 8 weeks of tailored (chemo)radiotherapy then will be followed until document progression disease, death, withdrawal of consent or end of trial (whichever occurs first). In addition of radiotherapy, patient will receive cisplatin or cetuximab (standard of care treatments).	Drug: Cisplatin; 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).; Drug: Cetuximab; 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.; Radiation: Tailored 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event Free Survival (EFS)	Event free survival (EFS) is defined as the time from randomisation to apparition of a documented relapse either local or regional or distant according to clinical or radiological assessment, or persistent residual disease including pathologically positive neck node, or death due to any cause.	At 6, 9, 15, 21 and 27 months from randomisation then annually assessed up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local relapse Free Survival	Local relapse Free Survival (lrFS, at site of primary tumor) is defined as the delay from randomisation to first local relapse (i.e. primary site) or death. Patients without documented event will be censured at the last adequate visit or tumor evaluation.	At 6, 9, 15, 21 and 27 months from randomisation then annually assessed up to 2 years
Regional relapse Free survival	Regional relapse Free survival (rrFS, in the neck) is defined as the delay from randomisation to first regional relapse (i.e. neck) or death.	At 6, 9, 15, 21 and 27 months from randomisation then annually assessed up to 2 years
Metastasis Free Survival	Metastasis Free Survival (mFS) is the time between randomisation and apparition of first metastasis (date of metastatic diagnosis). Patients without documented event will be censured at the last tumour evaluation.	At 6, 9, 15, 21 and 27 months from randomisation then annually assessed up to 2 years
Rate of pathologically positive lymph nodes	Rate of pathologically positive lymph nodes at neck node dissection performed at 4 months after the completion of (chemo)-radiotherapy for those patients benefiting from a neck node dissection	At 4 months from the completion of (chemo)-radiotherapy
Event Free Survival (EFS)	Event Free Survival (EFS) considering that pathologically positive neck node within 4 months post-randomisation will not be an event.	At 4 months from the completion of (chemo)-radiotherapy
Overall survival	Overall survival defined as the time from randomisation to death due to any cause. Patient without documented death at the time of analysis will be censored at the date of last known contact.	Until up to 2 years follow-up of the last patient enrolled
Adverse events	Incidence of any adverse events graded according to NCI-CTCAE V5.0	From the date of first intake of study drug until 27 months after the randomisation of the last randomised patient
Patient quality of life (EORTC QLQ-C30)	To assess the impact of the proposed combinations on patient' quality of life in the target population (EORTC QLQ-C30)	At randomisation, at 6, 9, 15, 21 and 27 months after randomisation and30 days after the last study treatments administration
Patient quality of life (EQ5-DL)	To assess the impact of the proposed combinations on patient' quality of life in the target population (EQ5-DL)	At randomisation, at 6, 9, 15, 21 and 27 months after randomisation and30 days after the last study treatments administration
Patient quality of life (EORTC QLQ-H&N43)	To assess the impact of the proposed combinations on patient' quality of life in the target population (EORTC QLQ-H&N43)	At randomisation, at 6, 9, 15, 21 and 27 months after randomisation and30 days after the last study treatments administration
Health economic analysis	To perform an economic analysis of the use of a tailored-RT with or without ATRA (Vesanoid). A cost-effectiveness methodology will be implemented, which involves computing costs and efficacy for each of the four treatment arms.	From the first patient enrolled to 2 years after treatment discontinuation of the last patient enrolled
Immunomonitoring	To study the impact of treatment on lymphocytes number and function, including by assessing immunosenescence induction and to study blood biomarkers predictive of response/toxicity following treatment	Cycle 1 Day 1 pre-dose of Vesanoid, Day 1 of radiotherapy and end of radiotherapy (8 to 10 weeks after randomisation)

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Principal Investigator: Vincent Grégoire, PhD, Centre Léon Bérard

Publications and helpful links

General Publications

• Gau M, Alfaraj FA, Huang SH, O'Sullivan B, Su J, Xu W, Hamilton SN, Maletta A, Salman O, McInerney M, Javed A, Sanz-Garcia E, Bratman S, Hahn E, Hope A, Kim JJ, Malik N, McPartlin A, Tsai CJ, Waldron J, Yao CMKL, de Almeida JR, Hosni A. Unilateral vs bilateral neck irradiation: The importance of careful patient selection in tailoring radiation therapy for lateralized palatine-tonsil and non-palatine-tonsil oropharyngeal carcinoma. Radiother Oncol. 2025 Sep;210:111049. doi: 10.1016/j.radonc.2025.111049. Epub 2025 Jul 19.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Vesanoid; Previously untreated; Localised squamous cell carcinoma of head and neck; Standard radiotherapy; Tailored radiotherapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Laryngeal Diseases; Head and Neck Neoplasms; Laryngeal Neoplasms; Oropharyngeal Neoplasms; Hypopharyngeal Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Diterpenes; Platinum Compounds; Vitamin A; Cetuximab; Cisplatin; Tretinoin
• Other Study ID Numbers: ET 22-156

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No