Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Laryngeal Diseases

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Oral Squamous Cell Carcinoma

Laryngeal Cancer

Hypopharyngeal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Cemiplimab

Antineoplastic Agents, Immunological

Participants will receive Cemiplimab for 6 consecutive months (a total of 8 cycles) 14-42 days after completion of standard of care CRT.

350 mg Cemiplimab administered via intravenous infusion over 30 minutes on Day 1 of a 21-day cycle.

Cemiplimab-Rwlc

Chukwuemeka Ikpeazu, MD

The purpose of this study is to evaluate the experimental immunotherapy agent cemiplimab-rwlc when given after completion of chemotherapy and radiation treatment and determine if it will improve progression free survival and cure rates in patients with PD-L1 positive locally advanced head and neck cancer.

Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC)

Phase II Trial of Maintenance Cemiplimab-rwlc After Concurrent Chemoradiotherapy (CRT) in Intermediate and High-Risk Head and Neck Squamous Cell Carcinoma (HNSCC)

Progression-Free Survival (PFS) is defined as the elapsed time from the date of starting maintenance treatment until disease progression or death (whichever occurs first). Patients who have not had an event will be censored at the date of last disease assessment documenting the patient was free of progression. Progression will be assessed using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.

PFS is defined as the elapsed time from the date of starting maintenance treatment until disease progression or death (whichever occurs first). Patients who have not had an event will be censored at the date of last disease assessment documenting the patient was free of progression. Progression will be assessed using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.

Overall survival (OS) will be defined as the elapsed time from the date of starting maintenance treatment (Cycle 1 Day 1) until death. Alive patients will be censored at the date of last known to be alive.

Safety of the intervention will be reported as the incidence of treatment-related toxicity, including serious adverse events (SAEs) and adverse events (AEs), in study participants using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.

Regeneron Pharmaceuticals

University of Miami

Associate Professor of Clinical

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

Central Nervous System Depressants

Anesthetics

The day before the laryngoscopy under general anesthesia (LGA), two endoscopies by two different physicians were performed for each patients and recorded: the first one with white light (WL) and the second one with NBI (NBI).

For each patient with a suspicion of squamous cell carcinoma of the oropharynx, hypopharynx or larynx for whom a laryngoscopy under general anesthesia (LGA) is expected benefit the day before a transnasal endoscopy with white lamp (WL) and NBI by two different operators. Suspected mucosal abnormalities showed by one or the two technics are reported in a table wich describes the different areas of the pharynx and the larynx. During the LGA, several biopsies are performed and identified (WL and/or NBI).

WL and NBI

Sébastien VERGEZ, MD, PhD

The aim of this study is to prospectively determine if the use of NBI endoscopy modifies the superficial extension of these tumors.

Several studies have already showed the interest of the use of NBI for the early diagnosis of malignancies of the upper aerodigestive tract. For all tumors, the most accurate evaluation of its limits is very important to perform the best strategy of treatment. If surgery seems to be the best option, surgical margins must be widely healthy. Despite the systematic transnasal flexible endoscopy with white lamp followed by laryngoscopy under general anesthesia (LGA) and tomodensitometric evaluation, surgical margins can be unhealthy (in situ carcinoma or dysplasia). We propose to evaluate if the use of the NBI could be useful to determine the superficial spread of squamous cell carcinomas in these locations.

To April 2013 to Mars 2015, all patients with a suspicion of squamous cell carcinoma of the oropharynx, hypopharynx or larynx and whom a LGA are expected, are included. The day before the LGA, two endoscopies by two different physicians were performed for each patients and recorded: the first one with white light and the second one with NBI. All results are noted on a schema. Superficial extension or synchronous lesions showed by NBI are analysed and compared with with lamp technic.

After surgery, surgical margins were evaluated and healthy margins were measured.

Interest of Narrow Band Imaging in Detection of Upper Aerodigestive Cancers

Usefulness of Narrow-band Imaging to Estimate the Superficial Spread of Squamous Cell Carcinomas in Oropharynx, Hypopharynx and Larynx

University Hospital, Toulouse

Mouth and Tooth Diseases

Digestive System Diseases

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grade superior or equal to 2 stomatitis injuries. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by an abacus.

The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute.

low level laser therapy

placebo (laser low level energy nonfunctional)

Eric JADAUD, MD

The purpose of the study is to assess in a randomized, double blind, controlled, multi-center, phase III study, the efficacy of low level diode laser (100 MW, 658 Nm), in the prevention and treatment of radiochemotherapy-induced mucositis for stage III and IV head and neck carcinomas.

This is a Phase III randomized, double-blind, multicenter study, with two groups of patients receiving radiotherapy and concomitant chemotherapy.

The patients will be randomized as follows: Arm A = patients will receive a preventive and curative treatment by low-energy laser, and arm B = a control group treated with standard local treatments and a placebo laser (laser nonfunctional).

Randomization will be balanced in a ratio 1: 1 and stratified by the investigator site. Assessments of mucositis, nutritional status, tolerance of the laser and pain will be performed throughout the treatment, once a week, by an investigator unaware of the patients treatment arm. The locoregional control will be evaluated every 3 months during the first year, then every 6 months up to 5 years. In case of progression, treatments undertaken and their results should be reported.

Radiotherapy: All patients will be treated with conformal radiotherapy with or without IMRT. The dose should be adapted to the treatment indication (exclusive or postoperative) and the histological findings in case of tumoral resection.

The radiotherapy will be prescribed in accordance with the recommendations of the ICRU 50 report. The dose delivered will always be 2 Gy per day 5 times a week. All beams will be treated in each session. A radiological audit will be conducted for each beam treated by photons in the first session and at least once a week.

Chemotherapy:

Several chemotherapies concomitant to radiotherapy are possible:

* a combination of 5-FU and Cisplatin
* a combination of 5-FU and Carboplatin
* Cisplatin alone
* Cetuximab alone

Dental care: All patients (except edentulous) will be seen in odontostomatology consultation prior to the treatment for dental care if necessary or potential production of fluorinated gutters During the treatment, all patients will receive oral care

The dosimetric study will concern the cross section, the frontal and sagittal planes through the axis of the lateral beams.

Arm A : laser low-level energy functional The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grades superior or equal to 2 stomatitis injuries. The application is painless, athermal, odorless and completely silent. The patient will wear glasses for retinal protection. The operator will also wear glasses for his protection but allowing nevertheless the view of the beams and its limits.

The tumor areas macroscopically invaded will be excluded from the areas application.

The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by a corresponding abacus : \[t(s) = energy (J/cm2) x surface (cm2) / puissance (W)\]. The overall duration will be a few minutes varying depending on the surface to be treated The usual dental care will be prescribed when required.

Arm B : laser low-level energy nonfunctional The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute. All applications will be performed by one single operator by center. The results will be assessed once a week by another physician (or nurse specifically trained) in each center, unaware of whether the patients had laser sessions or not, in order to respect the "blinding". The assessment will be detailed on a specifique sheet, specifying the degree of mucositis (WHO), the level of pain, body weight , type of feeding , any analgesic treatment taken by the patient, quality of life specific questionnaire, and the possible end of treatment or therapeutic modifications (number of cycles of chemotherapy, dosage).

The laser should be started as soon as a grade 2 mucositis (WHO) is observed and will be continued throughout the radio-chemotherapy until improvement of the mucositis (grade \<2).

Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer

A Randomized, Double Blind, Controlled, Multi-center, Phase III Study to Assess Efficacy of Low Level Diode Laser (100 MW, 658 Nm), in the Prevention and Treatment of Radiochemotherapy-induced Mucositis in Head and Neck Cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC)	NCT04831450	Head and Neck S... HNSCC Squamous Cell C... Squamous Cell C... Squamous Cell C...	Cemiplimab-Rwlc	18 Years -	University of Miami
Interest of Narrow Band Imaging in Detection of Upper Aerodigestive Cancers	NCT02035735	Squamous Cell C... Squamous Cell C... Squamous Cell C...	WL and NBI	18 Years -	University Hospital, Toulouse
Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer	NCT01772706	Oral Squamous C... Squamous Cell C... Squamous Cell C... Oral Mucositis	low level laser... placebo (laser ...	18 Years - 75 Years	Institut Cancerologie de l'Ouest
Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC)	NCT04831450	Head and Neck S... HNSCC Squamous Cell C... Squamous Cell C... Squamous Cell C...	Cemiplimab-Rwlc	18 Years -	University of Miami
Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer	NCT01772706	Oral Squamous C... Squamous Cell C... Squamous Cell C... Oral Mucositis	low level laser... placebo (laser ...	18 Years - 75 Years	Institut Cancerologie de l'Ouest

Spots Global Cancer Trial Database for squamous cell carcinoma of hypopharynx