Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Laryngeal Diseases

Laryngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

Low-risk is defined by:

* Planning target volume (PTV) less than 10 cc, AND
* No reported smoking within 1 month from registration

Radiation Therapy will be delivered twice per week for 5 fractions (total 42.5 Gy)

Moderate-risk is defined by:

* Planning target volume (PTV) greater than or equal to 10 cc, OR
* Smoking within 1 month from registration (no more than 1 pack per day)

Radiation Therapy will be delivered daily for 16 fraction (total 58.08 Gy)

Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT)

Radiation therapy

David Sher, MD

The goal of treatment with radiation therapy is to deliver as high of a dose as possible to the target (tumor), while minimizing the dose to the normal tissues where late-side effects can drastically affect patient quality of life.

Radiation will be delivered twice per week for 5 fractions (42.5 Gy cohort, low-risk) or daily for 16 fractions (58.08 Gy cohort, moderate-risk).

Low-risk is defined by:

* Planning target volume (PTV) less than 10 cc, AND
* No reported smoking within 1 month from registration

Moderate-risk is defined by:

* Planning target volume (PTV) greater than or equal to 10 cc, OR
* Smoking within 1 month from registration (no more than 1 pack per day)

Stereotactic Ablative Radiotherapy for Early-stage Glottic Larynx Cancer

A Phase II Study of Glottic Larynx Stereotactic Ablative Radiotherapy (LT-SABR) for Early-Stage Glottic Larynx Cancer

Local failure is defined as biopsy-proven tumor anywhere on the true vocal cords.

Voice Handicap Index (VHI) voice-quality score to monitor changes in self-perception of voice handicap before and after treatment.

0-30 Mild Minimal amount of handicap 31-60 Moderate handicap 60-120 Severe handicap

The M. D. Anderson Dysphagia Inventory (MDADI) to assess how patients view the outcome of their swallowing ability as a result of treatment and how this swallowing dysfunction affects their quality of life. MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning).

MDADI is a self-administered questionnaire designed specifically for evaluating the impact of dysphagia on the quality of life of patients with head and neck cancer

Number of patients with grade 3-5 acute (start of treatment through 90 days from the completion of treatment) and late (after 90 days from the completion of treatment) adverse events, according to NCI's Common Terminology Criteria for Adverse Events (CTCAE) v4.0 toxicity criteria.

Average patient utilities (derived from EQ-5D) at baseline, 6, 12, and 24 months from the end of treatment

EuroQol five dimension scale (EQ-5D) is a standardized instrument for measuring generic health status. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems

Specifically, the 2-year cumulative risk of biopsy-proven recurrence anywhere in the larynx or neck following SABR. Recurrence in this context includes biopsy-proven cancer anywhere in the supraglottic, glottic, or subglottic larynx, as well as any malignant lymph node in the cervical or supraclavicular lymph nodes.

With death and prior locoregional failure as competing risks

Laryngectomy-free survival probability at 2 years

University of Texas Southwestern Medical Center

Professor

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

François Mouawad, MD

Patients with early-stage squamous cell carcinomas of the vocal cord can be treated in an equivalent way in terms of carcinology by surgery or radiotherapy. The study will be to analyse the vocal outcome at 5 years of these two types of management in order to define whether one is superior to the other on this criterion of voice quality after treatment.

Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy

The VHI is a self-administered questionnaire that provides a score ranging from 0 to 120 points validated in France and internationally based on the declarative answers to 30 items of the questionnaire. A high score corresponds to a voice felt to be of poor quality. This is a subjective assessment made by the patient.

The TMP is the measurement in seconds of a vowel (/a/) held for as long as possible.

This score is obtained from an internationally and nationally validated hetero-assessment. It consists in the attribution by a listening jury made up of two people of a mark ranging from 0 to 3 for each of the 6 items: Grade, Roughness, Breathiness, Asthenia, Strain, Instability.

A high score is associated with a voice perceived as bad by the audience.

short recording of the patient's voice delivering a standardized speech on VOCALAB software validated by the scientific community.

University Hospital, Lille

Rare Diseases

Laryngeal Cancer

Hypopharyngeal Cancer

TLM group: Laryngeal carcinoma (LC) (supraglottic type and glottic type) and hypopharyngeal carcinoma (HPC) (pyriform sinus and posterior pharyngeal wall) patients with T1 and T2 stages can be treated with transoral laser microsurgery (CO2 laser resection) for proper indications (NCCN 2020).

OPL group: Open partial laryngectomy with laryngeal function preservation is performed for patients with laryngeal carcinoma (LC) (supraglottic type, glottic type, and subglottic type) and hypopharyngeal carcinoma (PHC) (pyriform sinus, postcricoid, and posterior pharyngeal wall) with proper indications (NCCN 2020).

R group: radiotherapy is treated for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with early stage with proper indications (NCCN 2020).

TORS group: transoral robotic surgery is performed for proper laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with early stage with proper indications.

SPA group: surgical treatment (S) ± postoperative adjuvant (PA) therapy is performed for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with advanced stage with proper indications (NCCN 2020).

CCR group: concurrent chemoradiotherapy (CCR) is performed for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with advanced stage with proper indications (NCCN 2020).

ARC group: neoadjuvant therapy (A) + radiotherapy/chemoradiotherapy (RC) is performed for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with advanced stage with proper indications (NCCN 2020).

ASRC group: neoadjuvant therapy (A) + surgery (S) + radiotherapy (R) or chemoradiotherapy (C) is performed for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with advanced stage with proper indications (NCCN 2020).

For early stage laryngeal carcinoma and hypohparyngeal carcinoma (T1 and T2), transoral laser microsurgery (CO2 laser resection), open partial laryngectomy (vertical partial laryngectomy, cricohyoidoepiglottopexy, cricohyoidopexy, horizontal partial laryngectomy), partial hypopharyngectomy, radiotherapy, and transoral robotic surgery were performed for patients with proper indications (NCCN 2020).

For advanced stage laryngeal carcinoma and hypohparyngeal carcinoma (T3 and T4), surgical treatment ± postoperative adjuvant therapy, concurrent chemoradiotherapy, neoadjuvant therapy + radiotherapy/chemoradiotherapy, or neoadjuvant therapy + surgery + radiotherapy or chemoradiotherapy were performed for patients with proper indications (NCCN 2020).

routines

Lei Tao, Dr.

Hongli Gong, Dr.

For early stage laryngeal carcinoma and hypohparyngeal carcinoma (T1 and T2), transoral laser microsurgery, open partial laryngectomy, radiotherapy, and transoral robotic surgery were performed according to NCCN guidelines (2020).

For advanced stage laryngeal carcinoma and hypohparyngeal carcinoma (T3 and T4), surgical treatment ± postoperative adjuvant therapy, chemoradiotherapy, neoadjuvant therapy + radiotherapy/chemoradiotherapy, or neoadjuvant therapy + surgery + radiotherapy or chemoradiotherapy performed according to NCCN guidelines (2020).

This study plan to analyze the clinical ouctomes of different treatment for the same T stage disease. The overall survival rate, disease specific survival, disease free survival, local control, regional control, and laryngeal function preservation rate were analyzed in this study.

For early stage laryngeal carcinoma and hypohparyngeal carcinoma (T1 and T2), transoral laser microsurgery (CO2 laser resection), open partial laryngectomy (vertical partial laryngectomy, cricohyoidoepiglottopexy, cricohyoidopexy, horizontal partial laryngectomy), partial hypopharyngectomy, radiotherapy, and transoral robotic surgery were performed for patients with proper indications.

For advanced stage laryngeal carcinoma and hypohparyngeal carcinoma (T3 and T4), surgical treatment ± postoperative adjuvant therapy, concurrent chemoradiotherapy, neoadjuvant therapy + radiotherapy/chemoradiotherapy, or neoadjuvant therapy + surgery + radiotherapy or chemoradiotherapy were performed for patients with proper indications.

This study seek to analyze and compare the clinical ouctomes of different treatments for the same T stage disease of LC and HPC.

The main end events involving overall survival rate, disease specific survival rate, and laryngeal function preservation rate were analyzed in this study. Beside, the events of disease free survival rate, local control rate, and regional control rate were assessed.

Clinical Treatments in Specialized Disease of Laryngeal Carcinoma (LC) and Hypopharyngeal Carcinoma (HPC)

Department of Otorhinolaryngology, Eye & ENT Hospital

the time between the treatment and the date of death from any causes

the time between the treatment and the date of death from laryngeal carcinoma or hypohparyngeal carcinoma

the time between the treatment and the date of laryngeal function preservation failure

the time between the treatment and the first evidence of disease recurrence, metastasis or death

the time between the treatment and the first evidence of local recurrence

the time between the treatment and the first evidence of regional recurrence

Changhai Hospital

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Fudan University

Shanghai Changzheng Hospital

RenJi Hospital

Shanghai 6th People's Hospital

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Eye & ENT Hospital of Fudan University

Director

Hypofractionated radiotherapy 58.08Gy/16 fractions to affected vocal cord plus margins to account for motion and setup errors using IMRT/VMAT technique

Radiotherapy 63Gy/28 fractions to whole larynx from lower border of hyoid bone to lower border of cricoid cartilage using IMRT/VMAT technique

Only the affected vocal cord with additional margin to account for motion and setup errors will receive 58.08Gy/16 fractions using IMRT/VMAT technique

Hypofractionated single vocal cord irradiation

The whole larynx from lower border of hyoid bone to lower border of cricoid cartilage will receive 63Gy/28 fractions using IMRT/VMAT technique

Whole laryngeal radiotherapy

Mohamed Mortada Elsharief

Tarek Shouman

The primary objective of this prospective randomized clinical trial is to assess non inferiority in terms of local control achieved with single vocal cord hypofractionated radiotherapy compared to standard of care whole laryngeal radiotherapy in patients with T1aN0 glottic cancer . Secondary objectives include overall survival rate and to compare the Voice Handicap Index score between the 2 arms as well as acute and late toxicities. Patients are randomized in 1:1 ratio.

Most laryngeal cancers present in early stage and more than two thirds of it occur in the glottic region(T1-T2). Early glottic carcinoma is historically treated with conventional radiotherapy using large box fields (from lower border of hyoid to lower border of cricoid), using wedged parallel opposed photon beams. In spite of good local control rate of more than 90% for T1a glottic cases, the tumor-free contralateral vocal cord, arytenoids, thyroid cartilage, and all muscles responsible for opening and closing the vocal cords, the swallowing muscles, carotid arteries and thyroid gland are exposed to high radiation doses (fully or partially) which could lead to an increased probability of complications that negatively influence the quality of life of these patients. Typical complications have involved voice/ speech impairment, diet problems (swallowing, trismus), arytenoids edema, an increased risk of strokes, and reduced treatment options for previously irradiated patients. Many studies showed that increasing fraction size and shortening the overall treatment time (hypofractionated radiotherapy) could result in better local control of T1 glottic cancer The use of 63Gy/28 Fractions(Fx) showed superior local control compared with conventional use of 66Gy/33Fx with shorter overall treatment time. Based on this study this dose is the standard in our institute. In contrast to the traditional radiotherapy principle to treat the whole larynx, surgical laser excision of T1a glottic cancer involves removal of gross tumor with minimal, often sub-millimeter, excisional margins with good oncological outcome and good quality of voice. Similar to this surgical concept and with modern radiotherapy IMRT/VMAT technique, the approach of single vocal cord irradiation (SVCI) was introduced. A study of 30 patients with T1a glottis cancer treated by image guided vocal cord radiotherapy was published in 2015 and it showed 100% local control at 2 years and with no grade 3 toxicities reported and better quality of voice when compared to historical cohorts Dosimetric analysis showed that IMRT resulted in markedly reducing the dose to contralateral cord, arytenoids, thyroid cartilage, inferior constrictor muscle and carotid arteries. To date no prospective phase 3 trial was done to compare treatment outcome and toxicity profile of vocal cord only hypofractionated radiotherapy vs traditional whole laryngeal radiotherapy.

Vocal Cord vs Whole Laryngeal Radiotherapy for T1aN0 Glottic Cancer

Vocal Cord Only Hypofractionated Radiotherapy vs Whole Laryngeal Radiotherapy for T1aN0 Glottic Cancer

Voice Handicap index score Scores are rated on a 0-4 scale to indicate the presence and severity of the symptoms. Lower scores represent better functioning and quality of life.

Rates of acute toxicity as per CTCAE v5.0

Rates of chronic toxicity as per CTCAE v5.0

Cairo University

National Cancer Institute, Egypt

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Papilloma

Tissue Adhesions

Constriction, Pathologic

Polyps

Leukoplakia

Laryngostenosis

Precancerous Conditions

Pathological Conditions, Anatomical

Congenital Abnormalities

Respiratory System Abnormalities

Laryngeal Papillomatosis

Anti-Inflammatory Agents

Antineoplastic Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Anti-Infective Agents

Curcumin

Mitomycins

Mitomycin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Enzyme Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Curcumin was applied to both wound sites of bilateral vocal cords. After evenly applied, gently massage the applied site for 3-5 minutes until the drug was fully absorbed.

Mitomycin-C was applied to both wound sites of bilateral vocal cords. After evenly applied, gently massage the applied site for 3-5 minutes until the drug was fully absorbed.

Mitomycin-C

Jian Chen, Ph.D

Haitao Wu, Ph.D

Jian Chen

To provide a novel therapy idea and method to solve the clinical problem of postoperative adhesion of bilateral vocal cords, patients enrolled in this study will be applied with curcumin on both wound sites of bilateral vocal cords after the surgery on the bilateral vocal cord endoscopically.

Clinical Study of Curcumin in Preventing Postoperative Adhesion of Bilateral Vocal Cords

All participants received the videolaryngoscope every month post-surgery, and a laryngeal web is defined as a visible adhesion whose length reached 1 mm or greater.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stereotactic Ablative Radiotherapy for Early-stage Glottic Larynx Cancer	NCT03548285	Glottic Carcino...	Radiation thera...	18 Years - 120 Years	University of Texas Southwestern Medical Center
Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy	NCT04447456	Glottic Carcino...		18 Years -	University Hospital, Lille
Clinical Treatments in Specialized Disease of Laryngeal Carcinoma (LC) and Hypopharyngeal Carcinoma (HPC)	NCT04908696	Glottic Carcino... Supraglottic Ca... Subglottic Carc... Pyriform Sinus ... Postcricoid Car... Posterior Phary...	routines	18 Years - 90 Years	Eye & ENT Hospital of Fudan University
Clinical Treatments in Specialized Disease of Laryngeal Carcinoma (LC) and Hypopharyngeal Carcinoma (HPC)	NCT04908696	Glottic Carcino... Supraglottic Ca... Subglottic Carc... Pyriform Sinus ... Postcricoid Car... Posterior Phary...	routines	18 Years - 90 Years	Eye & ENT Hospital of Fudan University
Vocal Cord vs Whole Laryngeal Radiotherapy for T1aN0 Glottic Cancer	NCT05679856	Larynx Cancer S... Glottic Carcino...	Hypofractionate... Whole laryngeal...	18 Years -	National Cancer Institute, Egypt
Clinical Study of Curcumin in Preventing Postoperative Adhesion of Bilateral Vocal Cords	NCT05688488	Glottic Web of ... Laryngeal Steno... Glottic Carcino... Laryngeal Leuco... Laryngeal Polyp Laryngeal Papil...	Curcumin Mitomycin-C	18 Years - 75 Years	Eye & ENT Hospital of Fudan University

Spots Global Cancer Trial Database for glottic carcinoma