Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Laryngeal Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Laryngeal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Induction phase:

Chemotherapy based on carboplatin 6 AUC (area under the curve) + paclitaxel 75 mg/m2 carboplatin 6 AUC 30-minute infusion on D: 1 (maximum carboplatin dose is 700 mg) paclitaxel 75 mg/m2 1-hour infusion on D: 1, 8, 15

Radiotherapy:

D:1 - 2 x 0,5 Gy (first dose up to one hour after the end of the carboplatin infusion, second dose 3 to 6 hours later), D:2 - 2 x 0,5 Gy (interval between doses not less than 3 hours), D:8 and D:15 - 2 x 0,5 Gy (first dose up to one hour after the end of the chemotherapeutic infusion, second dose 3 to 6 hours later).

Chemotherapy based on carboplatin 6 AUC + paclitaxel 75 mg/m2.

Radiotherapy:

D:1 - 2 x 0,5 Gy (first dose up to one hour after the end of the carboplatin infusion, second dose 3 to 6 hours later), D:2 - 2 x 0,5 Gy (interval between doses not less than 3 hours), D:8 and D:15 - 2 x 0,5 Gy (first dose up to one hour after the end of the chemotherapeutic infusion, second dose 3 to 6 hours later).

Chemotherapy (carboplatin+paclitaxel) with concomitant low dose ionizing radiotherapy

Tomasz Rutkowski, MD PhD

Agnieszka Pietruszka, MD

Krzysztof Składowski, MD PhD

Non-commercial clinical study to assess:

1. efficacy of iCHRTL in patients with advanced squamous cell carcinoma of oral cavity, pharynx carcinoma, larynx carcinoma or paranasal sinus carcinoma.
2. tolerability of iCHRTL in patients with advanced squamous cell carcinoma of oral cavity, pharynx carcinoma, larynx carcinoma or paranasal sinus carcinoma.
3. molecular and biochemical effect of low doses of ionizing radiation.

40 patients with squamous cell carcinoma of oral cavity, pharynx, larynx or paranasal sinuses in stage III or IV, previously not treated for this reason and eligible for induction chemotherapy.

Study treatment:

Induction phase:

Chemotherapy based on carboplatin 6 area under the curve (AUC) + paclitaxel 75 mg/m2 carboplatin 6 AUC 30-minute infusion on D: 1 (maximum carboplatin dose is 700 mg) paclitaxel 75 mg/m2 1-hour infusion on D: 1, 8, 15

Radiotherapy:

D:1 - 2 x 0,5 Gy (first dose up to one hour after the end of the carboplatin infusion, second dose 3 to 6 hours later), D:2 - 2 x 0,5 Gy (interval between doses not less than 3 hours), D:8 and D:15 - 2 x 0,5 Gy (first dose up to one hour after the end of the chemotherapeutic infusion, second dose 3 to 6 hours later).

2 cycles of induction treatment are planned. Interval between the last day of cycle I and the first day of cycle II is 7 days. After 2 weeks from second cycle Positron emission tomography (PET) and Magnetic Resonance (MR), medical case conference and qualification to further treatment: Radiotherapy (RT), Chemo-radiotherapy (CHRT) or other, depending on the medical decision.

Planned based on the optimal technique for a particular clinical case preferred: Intensity Modulated Radiation Therapy (IMRT). Preparation of IMRT plan will be based on computed tomography (CT) scans. Early tolerance of radiotherapy will be assessed for local reaction. At least once every 7 days.

Interventional, open, allocation to concomitant chemotherapy and low-dose ionizing radiotherapy

Induction Treatment in SCC of the Head and Neck Region - Concomitant Chemotherapy and Low-dose Radiotherapy

Induction Treatment in Patients With Squamous Cell Carcinoma (SCC) of the Head and Neck Region Consisting Concomitant Chemotherapy and Low-dose Ionizing Radiotherapy

Rate of local lesions complete response (CR) +partial response (PR)+stable disease (SD)

Rate of death within time from treatment start to 1 year

Rate of death within time from treatment start to 3 years

Medical Research Agency, Poland

Maria Sklodowska-Curie National Research Institute of Oncology

Mouth and Tooth Diseases

Gland and Hormone Related Diseases

Nasopharyngeal Neoplasms

Thyroid Neoplasms

Thyroid Diseases

Head and Neck Neoplasms

Nasopharyngeal Carcinoma

Mouth Neoplasms

Oropharyngeal Neoplasms

Salivary Gland Neoplasms

Laryngeal Neoplasms

Squamous Cell Carcinoma of Head and Neck

Endocrine System Diseases

Endocrine Gland Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Respiratory Tract Diseases

Mouth Diseases

Salivary Gland Diseases

Respiratory Tract Neoplasms

Oral Cancer

Hypopharyngeal Cancer

Lip and Oral Cavity Cancer

The aim is to differentiate between patients with head and neck cancer from those without based on a blood sample.

The aim is to identify recurrence through serial monitoring patients with blood samples.

The intervention is a liquid biopsy as a blood sample taken in a peripheral vein. The blood samples are analyzed for cell free DNA, RNA and HPV-DNA

Liquid biopsy

Christian Grønhøj, MD, Ph.D

Christian Von Buchwald, MD, DMSc

This study investigates if head and neck squamous cell carcinoma can be tracked with cell-free tumor DNA, RNA or HPV-DNA, in blood samples from patients referred with suspicion of cancer, and if it can be used in detecting recurrence in patients already diagnosed and treated for head and neck squamous cell carcinoma.

Cell-free Tumor DNA in Head and Neck Cancer Patients

Cell-free Tumor DNAand HPV-DNA in Blood Samples From Newly Diagnosed Patients With Head and Neck Cancer

The primary outcome is to measure the percentage of head and neck squamous cell carcinomas that can be detected using a liquid biopsy (blood sample)

The primary outcome is to measure the percentage of recurrence in head and neck cancer patients through serial monitoring with liquid biopsies (blood sample)

Copenhagen University Hospital, Denmark

Department of Otorhinolaryngology, Head and Neck Surgery and Audiology

Christian von Buchwald

Clinical Professor

Symptoms and General Pathology

Fistula

Pathological Conditions, Anatomical

Patients in both groups will then undergo salvage total laryngectomy STL surgery with primary suturing.The primary suture can be performed according to the different techniques available at the discretion of the surgeon (vertical, horizontal or T-shaped closure, with continuous suture, according to Connell or with detached stitches)31. It would be preferable for all centers to use a homogeneous pharyngeal suture technique, such as the T-shaped with Connell suture.

Patients in both groups will then undergo salvage total laryngectomy STL surgery with primary suturing, but in the patients of the second group, in addition, the positioning of a free/pedunculated covering flap will also be carried out with the onlay technique. Reconstruction with the onlay technique can be performed using a pedicled pectoralis major myofascial flap or anterolateral thigh myofascial free flap at the surgeon's discretion (pharyngeal suture unchanged). The flap will be positioned with an onlay technique to reinforce the pharyngeal suture and in turn sutured to the prevertebral fascia or residual surrounding tissues.

The primary suture can be performed according to the different techniques available at the discretion of the surgeon (vertical, horizontal or T-shaped closure, with continuous suture, according to Connell or with detached stitches)

Primary suture

Raul Pellini, Doctor

Pellini Raul, Doctor

Multicenter, prospective, randomized study aimed at evaluating the difference in risk of PCF after salvage laryngectomy in two groups of patients: one cohort treated with Total Laryngectomy (LT) with primary suture, a second group treated with LT and reinforcement by flap positioning with onlay technique (PMM, ALT)

Patients, once eligibility has been verified, will then be randomized (1:1) to one of the following groups: Gruop 1: STL primary suture. Group 2: STL primary suture + onlay flap Patients in both groups will then undergo surgery STL with primary suture; in those of the second group, in addition, the positioning of a free/pedunculated covering flap will also be carried out with the onlay technique. 4 months after surgery, questionnaires will be administered to the patient for the subjective evaluation of the quality of life in relation to vocal rehabilitation obtained through voice prosthesis or esophageal voice (SECEL questionnaire) and swallowing rehabilitation (SOAL questionnaire). Demographic and preoperative data will be collected, data relating to pre-(chemo-)radiotherapy and pre-STL clinical staging, as well as the interval in days between the end of (chemo-)radiotherapy and surgery, perioperative data, type of eventual unilateral or bilateral laterocervical lymph node emptying, the type of pharyngotomy suture, the type of flap possibly used, the packaging of the tracheoesophageal fistula for positioning the voice prosthesis, the definitive histological examination.

The patient must undergo a radiological examination for loco-regional and distant staging before the STL (CT or MRI) and a biopsy demonstrating the recurrence/persistence of the disease.

The Role of the Free/Pedunculated Flap in Total Laryngectomy After (Chemo-)Radiotherapy Failure for Laryngeal Carcinoma: Impact on the Risk of Pharyngocutaneous Fistula (PCF)

Questionnaires will be administered to the patient for the subjective evaluation of the quality of life in relation to vocal rehabilitation obtained through voice prosthesis or esophageal voice (SECEL questionnaire).

Identification of risk factors related to the formation of pharyngocutaneous fistulas after salvage total laryngectomy

Evaluation of swallowing function assessed using the SOAL questionnaire

Evaluation of vocal rehabilitation using the SECEL questionnaire

Regina Elena Cancer Institute

Tissue Adhesions

Angiogenin

20 healthy age- and sex- matched controls

Blood samples were obtained at time of diagnosis and will be analyzed for the levels of biomarker candidate molecules.

Obtaining blood samples

Gurcan Gunaydin, MD, PhD

Nilda Suslu

The aim of this study was to determine serum levels of VEGF, sVEGFR1, VEGFR2, IGFBP-3, angiogenin and endoglin in patients with larynx squamous cell carcinoma; investigate their association with clinical parameters and determine their diagnostic and prognostic value.

Although there has been a significant increase in survival in many other cancer types through the years, no significant increase has been achieved in laryngeal SCC survival rates in the last 50 years. Despite the advancements in surgical techniques, organ preservation protocols and multidisciplinary approach, significant amount of patients have been living with morbidity or dying due to recurrence and metastasis. This lack of significant improvement in mortality rates creates the need for reliable and accurate biomarkers in early diagnosis, treatment and follow-up. Considering that the prognosis of two patients at the same clinical stage and treated with the same treatment protocol may differ, it suggests that there may be some differences at the molecular level apart from clinical stages.

This study was mainly prepared to determine serum levels of VEGF, sVEGFR1, VEGFR2, IGFBP-3, angiogenin and endoglin in patients with larynx squamous cell carcinoma; investigate their association with clinical parameters and determine their diagnostic and prognostic value.

To reach these aims, 60 patients who were prospectively and consecutively recruited from those who admitted to Hacettepe University, Department of Otorhinolaryngology, Ankara, Turkey, and were diagnosed with LSCC between May 2018 and February 2020. 20 healthy and age-matched controls were chosen from the hospital staff and relatives of the patients. Serum samples were obtained from all participants at the time of diagnosis, centrifuged and stored at -80 C. ELISA method will be used to analyze the serum levels of VEGF, sVEGFR1, VEGFR2, IGFBP-3, angiogenin and endoglin.

Data analysis will reveal if there are any association between biomarker candidate molecules and clinical parameters.

An Investigation of Biomarker Candidate Molecules in Laryngeal Carcinoma

An Investigation of Clinical Parameters and Biomarkers Associated With Angiogenesis, Proliferation, Cell Adhesion and Invasion in Laryngeal Carcinoma

Serum levels of:

VEGF in pg/ml

sVEGFR1 in pg/ml

VEGFR2 in pg/ml

IGFBP-3 in pg/ml

angiogenin in pg/ml

and endoglin in pg/ml

will be determined in all participants

Disease stage as stage as early (I-II) or late (III-IV)

Receiver operating characteristic analysis will be performed to determine a significant level of any biomarker candidate molecules for diagnostic sensitivity and sensitivity.

Sensitivity and specifity as percentages (%)

Tumor localization as glottic/supraglottic or transglottic

Treatment modality as surgical, non-surgical or combined

All the patients were contacted for survival analysis.

Overall and disease-free survival will be measured in months and survival rates will be calculated in percentages (%).

Overall survival and disease-free survival rates will be calculated according to levels of biomarker candidate molecules and assessed for any association with any molecule.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Induction Treatment in SCC of the Head and Neck Region - Concomitant Chemotherapy and Low-dose Radiotherapy	NCT05992610	Squamous Cell C... Pharynx Carcino... Larynx Carcinom... Paranasal Sinus...	Chemotherapy (c...	18 Years -	Maria Sklodowska-Curie National Research Institute of Oncology
Cell-free Tumor DNA in Head and Neck Cancer Patients	NCT03942380	Head and Neck C... Head and Neck N... Head and Neck S... Oropharynx Canc... Oropharynx Neop... Oropharynx Carc... Oral Cavity Can... Oral Cancer Oral Neoplasm Larynx Cancer Larynx Carcinom... Larynx Neoplasm Nasopharyngeal ... Nasopharyngeal ... Nasopharynx Neo... Hypopharynx Can... Hypopharynx Neo... Hypopharynx Car... Sinonasal Carci... Thyroid Carcino... Thyroid Cancer Thyroid Neoplas... Salivary Gland ... Salivary Gland ... Salivary Gland ... Sinonasal Cance... Sinonasal Neopl...	Liquid biopsy	18 Years -	Rigshospitalet, Denmark
The Role of the Free/Pedunculated Flap in Total Laryngectomy After (Chemo-)Radiotherapy Failure for Laryngeal Carcinoma: Impact on the Risk of Pharyngocutaneous Fistula (PCF)	NCT06287034	Larynx Carcinom...	Primary suture	18 Years -	Regina Elena Cancer Institute
An Investigation of Biomarker Candidate Molecules in Laryngeal Carcinoma	NCT05217147	Larynx Cancer Larynx Carcinom...	Obtaining blood...	-	Hacettepe University
An Investigation of Biomarker Candidate Molecules in Laryngeal Carcinoma	NCT05217147	Larynx Cancer Larynx Carcinom...	Obtaining blood...	-	Hacettepe University
Cell-free Tumor DNA in Head and Neck Cancer Patients	NCT03942380	Head and Neck C... Head and Neck N... Head and Neck S... Oropharynx Canc... Oropharynx Neop... Oropharynx Carc... Oral Cavity Can... Oral Cancer Oral Neoplasm Larynx Cancer Larynx Carcinom... Larynx Neoplasm Nasopharyngeal ... Nasopharyngeal ... Nasopharynx Neo... Hypopharynx Can... Hypopharynx Neo... Hypopharynx Car... Sinonasal Carci... Thyroid Carcino... Thyroid Cancer Thyroid Neoplas... Salivary Gland ... Salivary Gland ... Salivary Gland ... Sinonasal Cance... Sinonasal Neopl...	Liquid biopsy	18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for larynx carcinoma