Neoplasms

All Conditions

Nervous System Diseases

Heart and Blood Diseases

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Thoracic Outlet Syndrome

Oropharyngeal Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Hypopharyngeal Cancer

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.

The following surgical techniques are allowed:

Transoral Robotic Surgery (TORS) Transoral Microsurgery (TLM) Conventional trans-oral Surgery (CTOS)

IMRT (Simultaneous Integrated Boost (SIB) and accelerated regimen) with selective neck node dissection

Intensity-Modulated Radiation Therapy (IMRT)

TOS (Trans Oral Laser Microsurgery (TLM), Trans Oral Robotic Surgery (TORS), conventional) with selective neck node dissection

Trans Oral Surgery (TOS)

EORTC HQ

Sébastien Van Der Vorst, MD

Sandra Schmitz, MD

Esther Willemse, MD

Sandra Nuyts, MD

Philippe Schultz, MD

Frank Peter Sieker, MD

Ulrich Kisser, MD

Christian Betz, MD

Cordula Petersen, MD

Andrea Wittig, MD

Orlando Guntinas-Lichius, MD

Jens Peter Klussmann, MD

Christian Baues, MD

Benedikt Hofauer, MD

Steffi Pigorsch, MD

Simon Boeke, MD

Paul-Stefan Mauz, MD

Thomas Hoffmann, MD

Thomas Weigel, MD

Giuseppe Spriano, MD

Mohssen Ansarin, MD

Wojciech Golusinski, MD

Jon Alexander Sistiaga Suarez, MD

Rafael Barbera, MD

Fernando Lopez Alvarez, MD

Frank Zimmermann, MD

Roland Giger, MD

Chistian Simon, MD

Martina Anja Broglie Daeppen, MD

Matthew Beasley, MD

Ekpemi Irune, MD

Sandeep Berry, MD

Lorcan O Tool, MD

Terry Jones, MD

Asit Arora, MD

Zaid Awad, MD

Shane Lester, MD

Christian Simon

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.

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.

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

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

European Organisation for Research and Treatment of Cancer - EORTC

Behaviors and Mental Disorders

Quality of Life

Patients operated by Trans-oral Robotic Surgery (TORS)

Patients operated by Trans-oral Laser Microsurgery (TLM)

Patients treated by Intensity Modulated Radiation Therapy (IMRT)

* Arm 1: Intensity-Modulated Radiation Therapy (IMRT)
* Arm 2: Trans-oral Laser Microsurgery (TLM)
* Arm 3: Trans-oral Robotic Surgery (TORS)

TORS

Hassid Samantha, Doctor

Hassid Dr Samantha, Doctor

In this project, the investigators will realize an observational, prospective, multicentric and international clinical trial, to objectively compare patients with SSCC according to 3 arms of treatment:

* Arm 1: Radiotherapy ± chemotherapy
* Arm 2: Trans-oral Laser Microsurgery (TLM)
* Arm 3: Trans-oral Robotic Surgery (TORS)

The main goal is to evaluate the efficacy of each treatment with four classes of outcomes:

* The quality of life (QoL) before and after each treatment option, using validated questionnaires
* Oncological outcomes
* Functional outcomes
* Economical Resources

The population will include cT1-T2 /cN0-N1/M0 supraglottic squamous cell carcinoma.

The primary outcome is a Clinical Dysphagia QoL evaluation assessed by the MD Anderson Dysphagia questionnaire. Secondary outcomes include others QoL evaluation, oncological and functional measures and cost parameters. The sample size needs to reach 36 patients per arm (total 108).

Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies

Treatment of Supraglottic Squamous Cell Carcinoma With Advance Technologies: Observational Evaluation of Quality of Life, Oncological Outcomes, Functional Outcomes and Economical Resources

Clinical Dysphagia QoL evaluation after treatment will be assessed using MD Anderson Dysphagia Index (MDADI). MDADI consists of 20 items pooled in 4 subscales: the global scale (1 item); the functional scale (5 items); the physical scale (8 items); and the emotional scale (6 items). All items are scored on a 5-point scale (1-5), where "1" corresponds to "total agreement" and "5" to "total disagreement." All except 2 items were scored such that higher scores indicated higher functioning. Responses on all domains were summed to calculate the total score (MDADI-T). The maximum score is 100, indicating high functioning, and the minimum score is 20, indicating poor functioning.

QoL will be evaluated with the validated European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire It is composed on five functional scales (physical, performance, cognitive, emotional and social), three symptoms scale (fatigue, pain, nausea and vomiting), a global health status/QoL scale and 6 simple items for assessment of symptoms or additional problems (dyspnea, loss of appetite, insomnia, financial difficulties, constipation and diarrhea). All of the scale and single item measures range in score from 0 to 100. Regarding functional and overall health status scales, higher scores relate to better quality of life; however, for the scales of symptoms, higher scores correspond to the higher presence of this symptom and, consequently, the worse quality of life.

QoL will be evaluated with the validated European Organization for Research and Treatment of Cancer (EORTC) H\&N43 questionnaire It comprises 43 questions about symptoms and side effects of treatment, social function, body image and sexuality. It incorporates 12 symptom scales (pain, swallowing, problems with teeth, dry month and sticky saliva, problems with senses, speech, body image, social eating, sexuality, problems with shoulder, skin problems and fear of progression) and 7 simple items (problems opening mouth, coughing, social contact, swelling in the neck, weight loss, problem with wound healing and neurological problems). All of the scales and the single item measures range in score from 0 to 100. A high score represents a high level of symptomatology or problems.

Swallowing function by FEES evaluation (Fiberoptic Endoscopic Evaluation of Swallowing) objectively evaluated by the Penetration-aspiration Scale (PAS) The PAS is an 8-point scale that rates the degree of airway invasion. Score of 1 is normal, score between 2-5 represent laryngeal penetration and scores up to 6 indicate airway aspiration.

CTC-AE Score for early and late complication The Common Terminology Criteria for Adverse Events (CTC-AE) is a descriptive terminology which was published by the National Cancer Institute (NCI) as part of an ongoing effort to standardize adverse events (AE) reporting within oncology. AE are graded according to an ordinal scale where 1 represents asymptomatic or mild symptoms and 5 represents death from the AE. In between, 2 is moderate, 3 is severe, and 4 is life-threatening. E.g., with regard to dysphagia, the CTCAE uses the descriptive terminology listed in Table 1, columns 1 and 2. CTCAE dysphagia grades are based on symptoms, diet, and tube dependency. This scale will be filled in by the physician.

Naso-gastric Feeding tube and/or gastrostomy use (duration in days)

Need of hospitalization (yes or no; if yes, duration in days)

Centre Hospitalier Universitaire UCLouvain Namur

Professor

All patients underwent primary tumour resection with transoral robotic surgery (TORS) using the daVinci robot (Intuitive Surgical, Sunnyvale CA)

Transoral robotic surgery (TORS)

Transoral robotic surgery is an option to treat supraglottic squamous cell carcinomas. Oncological outcomes 2 years after transoral robotic surgery for supraglottic laryngectomy were studied.

Local Control After Robot-assisted Supraglottic Laryngectomy

Evaluation of Local Control 2 Years After Robot-assisted Supraglottic Laryngectomy: a Multicenter Retrospective Study

Proportion of patients without cancer recurrence 2 years after surgery

Hospices Civils de Lyon

Transoral robotic surgery using the daVinci robot to remove primary tumor

Transoral robotic surgery

Katherine L Fedder, MD

The purpose of this study is to learn more about the outcomes of treatment of throat and voice box cancers using transoral robotic surgery (TORS). TORS is a relatively new option involving the use of the da Vinci surgical robot to remove these cancers through the mouth.

Efficacy and Safety of TORS for SCCA

A Single Arm Study of Efficacy and Functional Quality of Life in Patients Treated With Transoral Robotic Surgery for Oropharyngeal and Supraglottic Squamous Cell Carcinoma

Measured from the date of surgery until date of death from any cause

Subject-reported functional outcome questionnaires will be used to quantify patient-reported speech and swallowing function

Adverse events occuring following the surgery will be reported and graded using CTCAE v4.0 criteria

Duration of time from date of surgery to date of recurrence or death

Duration of time from the date of surgery until death with disease present

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma	NCT02984410	Oropharyngeal C... Supraglottic Sq... Hypopharyngeal ...	Intensity-Modul... Trans Oral Surg...	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies	NCT05611515	Supraglottic Sq... Early Stage (T1...	TORS	18 Years -	Centre Hospitalier Universitaire UCLouvain Namur
Local Control After Robot-assisted Supraglottic Laryngectomy	NCT03357107	Supraglottic Sq...	Transoral robot...	18 Years -	Hospices Civils de Lyon
Efficacy and Safety of TORS for SCCA	NCT01819480	Oropharyngeal S... Supraglottic Sq...	Transoral robot...	18 Years -	University of Virginia
Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma	NCT02984410	Oropharyngeal C... Supraglottic Sq... Hypopharyngeal ...	Intensity-Modul... Trans Oral Surg...	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC

Spots Global Cancer Trial Database for supraglottic squamous cell carcinoma