Phase III study assessing the *best of* radiotherapy compared to the *best of* surgery (trans-oral surgery (TOS)) in patients with T1-T2, N0-N1 oropharyngeal, supraglottic carcinoma and with T1, N0 hypopharyngeal carcinoma

Phase 3

Recruiting

• Conditions: Oropharygeal caricoma; supraglottic and hypopharyngeal carcinoma; throat cancer; 10027656; 10019190

• Registration Number: NL-OMON54095
• Lead Sponsor: European Organisation for Research in Treatment of Cancer (EORTC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

OPSCC in one of the following sub-sites: base of tongue, lateral pharyngeal
wall, tonsil, glosso-tonsillar sulcus, vallecula or SGSCC in one or more of the
following sub-sites: epiglottis, aryepiglottic fold, false cord or HPSCC in one
or more of the following subsites: Lateral and medial wall of piriform sinus
(sub-sites are defined as lateral (lateral pharyngeal wall, tonsil,
glosso-tonsillar sulcus, lateral wall of piriform sinus) vs. central lesions
(base of tongue, vallecula, all supraglottic sites, medial wall of piriform
sinus))
• TNM stage I-III (7th AJCC classification) for OPSCC and SGSCC: T1 or T2, N0
or T1 or T2, N1 with one single neck node <= 3cm without radiographic signs of
extracapsular extension (ECE), M0
• TNM stage I for HPSCC: T1, N0, M0
Within 2 weeks before randomization, assessment by a Multi-Disciplinary Team
(MDT) composed of at least a head and neck/ENT surgeon, medical oncologist,
radiologist, radiotherapist, and pathologist of the treatment naïve patient and
suitable for either TOS or IMRT based on:
• Contrast enhanced CT and/or MRI done within 4 weeks prior to randomization

• Repeat contrast enhanced CT and/or MRI or US 1 week or less prior to
enrollment in case of suspicious nodes <1cm on initial scan if per local
practice
• Panendoscopy with assessment of trans-oral exposure for resection.
• peri-nodal infiltration either via CT-scan or MRI.
• ECOG Performance status <= 2;
• Availability of biological material for HPV/p16 testing for OPSCCs
• Age 18 and older; Age 18 to 70 for SGSCC
• Study information and Informed consent discussed by the surgeon and
radio-oncologist and signed by the patient.

• Within 2 weeks prior randomization:
• Baseline MDADI score available;
• Adequate bone marrow function as demonstrated by neutrophils count > 1,5 109
/L , platelets count > 75 109 /L, WBC>= 3.0 109 /L;
• Prothrombin time (PT) with an international normalized ratio (INR) <= 1.2
• Partial thromboplastin time (PTT) <= 1.2 times ULN
• Women of child bearing potential (WOCBP) must have a negative serum or urine
pregnancy test no more than 72 hours prior to randomization.
• Patients of childbearing / reproductive potential should agree to use
adequate birth control measures for 6 months, especially if they will undergo
any radiotherapy treatment at any time during the study. A highly effective
method of birth control is defined as those which result in low failure rate
(i.e. less than 1% per year) when used consistently and correctly.

Exclusion Criteria

Any previous anti-cancer therapy for HNSCC (surgery, chemo, radiotherapy or
molecularly targeted therapy);
• Any active malignancy (other than non-melanoma skin cancer or localized
cervical cancer or localized and presumed cured prostatic cancer) within the
last 5 years with ongoing systemic treatment
• Cancer in contact with the internal and/or common carotid artery
• Extension of OPSCC across the midline of the base-of-tongue
• Arytenoid involvement in case of SGSCC
• Infiltration of apex for piriform sinus in case of HPSCC
• Cancer originating from the soft palate or posterior pharyngeal wall
• Requirement of a reconstruction with a free or regional flap (i.e.
involvement of >50% of the soft palate)
• Pre-existing dysphagia not related to the oropharyngeal cancer or diagnostic
biopsies

• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified