Oropharygeal caricoma supraglottic and hypopharyngeal carcinoma throat cancer
Conditions
Interventions
Eligible patients will be randomized 1 to 1 to TOS (Arm 1) or IMRT (Arm 2), 
stratifying for tumor localization (lateral lesions: Lateral wall, tonsil, 
glosso-tonsillar sulcus, lateral piriform sinus
central lesions: base of 
tongue, vallecula, supraglottis, medial piriform sinus), N stage (T1/2N0 vs 
T1/T2N1), MDADI score at baseline (below and above 67.0 points) and country.
Sponsors
European Organisation for Research in Treatment of Cancer (EORTC)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the MDADI score reported by the patient at 12 months after randomization. • The MDADI scale is composed of 19 items: Emotional (6 questions), Functional (5 questions), Physical (8 questions) and the total MDADI score ranges from 20 (extremely low functioning) to 100 (high functioning). • The study is powered to test the treatment difference at the 12 months* time point. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-reported MDADI at 4.5, 6 and 9 months • Response after study treatment (measured at 6 months after randomization) • Recurrence-free survival after complete response (CR) • Local, regional, loco-regional and distant tumor control after CR • Overall, disease specific and event free survival • Second cancer • Functional and HRQOL measures (PSS-HN, 100 ml swallow test, feeding tube use, EORTC QLQ-C30 and H&N43) Other secondary endpoints involve these same evaluations up to 5 years. In general, clinical evaluation, pan-endoscopy with biopsy if indicated, imaging scans taken at 6 months after randomization and evaluation of the MDT shall be performed during the treatment and follow-up periods to evaluate recurrence or progression. In the Best of Study, methods and schedule of follow up are based on the NCCN guidelines as of 2016. | — |
Countries
Netherlands
Outcome results
None listed