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.

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
France
Institut de Cancérologie de l'Ouest - Paul Papin
RECRUITING
Angers
Centre Oscar Lambret
RECRUITING
Lille
Centre Léon Bérard
RECRUITING
Lyon
Centre Antoine Lacassagne
RECRUITING
Nice
AP-HP - Hôpital Tenon
RECRUITING
Paris
Institut de Cancérologie de Lorraine
RECRUITING
Vandœuvre-lès-nancy
Institut Gustave Roussy
RECRUITING
Villejuif
Contact Information
Primary
Vincent Grégoire, PhD
vincent.gregoire@lyon.unicancer.fr
4 69 85 62 53
Time Frame
Start Date: 2025-02-20
Estimated Completion Date: 2029-01
Participants
Target number of participants: 460
Treatments
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).
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).
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).
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).
Related Therapeutic Areas
Sponsors
Leads: Centre Leon Berard

This content was sourced from clinicaltrials.gov

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