Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma (Best Of)

  • STATUS
    Recruiting
  • End date
    Sep 28, 2029
  • participants needed
    112
  • sponsor
    European Organisation for Research and Treatment of Cancer - EORTC
Updated on 28 July 2022
platelet count
cancer
carcinoma
squamous cell carcinoma
neutrophil count
head and neck cancer
intensity-modulated radiation therapy
robotic surgery
neck dissection
oropharyngeal carcinoma
oropharyngeal squamous cell carcinoma
extracapsular extension

Summary

Oropharyngeal Squamous Cell Carcinoma (OPSCC) arises in the soft palate, tonsils, base of tongue, pharyngeal wall, and the vallecula. Most of the patients with early stage OPSCC are usually cured. Treatment of early stage OPSCC can be successfully achieved with primary surgery including neck dissection, as indicated, or with definitive radiotherapy. The current standard treatment for OPSCC is therefore based on either surgery and/or radiotherapy, both associated with comparable, high tumor control rates but with different side effects profiles and technical constraints.

In order to decrease the potential morbidity of surgery, transoral approaches have been developed within the last decades, including transoral robotic surgery (TORS), transoral laser microsurgery (TLM) or conventional transoral techniques. On the other hand, patients with head and neck cancer treated with IMRT experienced significant improvements in cause specific survival (CSS) compared with patients treated with non-IMRT techniques thus suggesting that IMRT may be beneficial in terms of patient's outcomes and toxicity profile. It is as yet unclear however, which one of the new techniques is superior to the other in terms of function preservation. Given that the functional outcome of most importance is swallowing function, the preservation of swallowing is thus of major importance.

The main objective of the study is to assess and compare the patient-reported swallowing function over the first year after randomization to either IMRT or TOS among patients with early stage OPSCC, SGSCC, and HPSCC.

Description

Eligible patients will be randomized 1 to 1 to surgery (Arm 1) or radiotherapy (Arm 2).

ARM 1: Surgery

Trans-oral surgery (any trans-oral approach such as trans-oral laser microsurgery conventional trans-oral surgery or trans-oral robotic surgery) will be applied to all patients in this arm.

A surgical margin is defined to be clear (R0), if found to be >/=3mm in the final specimen (except deep margin for tonsillar resection, that is either R1 or R0), is defined to be close, if 1-<3mm, and considered to be involved (R1), if <1mm in the final specimen. Clearly defined marginal biopsies are required for each TOS-technique. Trans-oral re-resections are required in case of R1 or close-margin to convert the patient to an R0-status.Postoperative RT or chemo-RT will be given within 5-6 weeks of surgery in case of positive.

ARM 2: Radiotherapy

Intensity modulated radiation therapy (IMRT) with Simultaneous integrated boost (SIB) will be applied to all patients in this arm. PTV prescription to tumor and high risk areas will be delivered daily for 5 days per week to a total dose of 66-70Gy in 2 Gy/fraction over 6 weeks, elective/prophylactic mucosal and nodal areas will receive a total dose of 54.25- 54.45 Gy in 33-35 fractions of 1.55-1.65 Gy over 6 weeks.

Details
Condition Oropharyngeal Cancer, Supraglottic Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma
Treatment Intensity-modulated radiation therapy (IMRT), Trans Oral Surgery (TOS)
Clinical Study IdentifierNCT02984410
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last Modified on28 July 2022

Eligibility

Yes No Not Sure

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 piriform sinus) vs. central lesions (base of tongue, vallecula, all supraglottic sites, medial wall of piriform sinus))
TNM stage I-III (7th AJCC classification): 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, oncologist, radiologist, radiotherapist, and pathologist of the treatment naïve patient and suitable for either TOS or IMRT based on
CT with contrast and/or MRI done within 4 weeks prior to randomization Note: Repeat contrast enhanced CT and/or MRI or US 1 week or less prior to randomization in case of suspicious nodes <1cm on initial scan if per local practice
Pan-endoscopy with assessment of trans-oral exposure for resection
Age 18 and older; Age 18 to 70 for SGSCC
peri-nodal infiltration either via CT-scan or MRI
Availability of biological material for HPV/p16 testing for OPSCCs
Study information and Informed consent discussed by the surgeon and radio-oncologist and signed by the patient
ECOG Performance status ≤ 2
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 3 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-, or radiotherapy or molecular 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
Pre-existing dysphagia not related to the oropharyngeal cancer or diagnostic biopsies
Requirement of a reconstruction with a free or regional flap (i.e. involvement of >50% of the soft palate)
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
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