Neoplasms

All Conditions

Digestive System Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Neoplasms

Squamous Cell Carcinoma of Head and Neck

Deglutition Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Pharmaceutical Solutions

All Drugs and Chemicals

Coagulants

Lugol's solution

A total of 132 patients with HNSCC were enrolled in this study. The patients underwent esophagoscopy and chromoendoscopy. The most frequent primary tumors were oropharyngeal (49/132), tumors of the oral cavity (36/132) and larynx (35/132). The majority of subjects (107/132 patients, 81.1%) had advanced HNSCC carcinomas (stages III and IV). Multiple LVLs were discovered in 24 subjects (18.2%), and no LVLs in 108 (81.8%) subjects. Fifty-five LVL biopsy specimens were obtained and assessed. Squamous cell carcinomas were detected in two patients, peptic esophagitis in 11 patients, gastric heterotopic mucosa in two patients, hyperplasia in two patients, and low- and high-grade dysplasia in three patients.

Esophagoscopy - examination of the interior of the esophagus by means of an esophagoscope.

Chromoendoscopy - a method, which involves the topical application of stains or pigments to improve tissue localization, characterization, or diagnosis during endoscopy.

Esophagoscopy and chromoendoscopy

Pavel Kominek, MD, PhD, MSc

Patients with HNSCC represent a high-risk group for the development of SESCC. Thus, esophagogastrofibroscopy should be performed to detect possible synchronous esophageal carcinomas in these patients.

Although only two patients with synchronous primary carcinomas were found among the patients with newly diagnosed HNSCC in this study, esophagoscopy and better some of advanced endoscopic methods should be recommended after detection of HNSCC to exclude secondary esophageal carcinoma or dysplasia. Staining of the esophagus with Lugol's solution is an easy and inexpensive option and can be done in most of gastroenterology offices.

ABSTRACT Objective: To evaluate the use of flexible esophagoscopy and chromoendoscopy with Lugol's solution in the detection of early esophageal carcinomas (second primary carcinomas) in patients with squamous cell carcinoma of the head and neck (HNSCC).

Methods: All patients with newly diagnosed HNSCC underwent office-based Lugol chromoendoscopy. After flexible esophagoscopy with white light, 3.0% Lugol iodine solution was sprayed over the entire esophageal mucosa. Areas with less-intense staining (LVLs) were evaluated and biopsies taken.

Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma

Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma in Patients With Squamous Cell Carcinomas of the Head and Neck?

To evaluate the use of flexible esophagoscopy and chromoendoscopy with Lugol's solution in the detection of early esophageal carcinomas (second primary carcinomas) in patients with squamous cell carcinoma of the head and neck (HNSCC).

All patients with newly diagnosed HNSCC underwent office-based Lugol chromoendoscopy. After flexible esophagoscopy with white light, 3.0% Lugol iodine solution was sprayed over the entire esophageal mucosa. Areas with less-intense staining (LVLs) were evaluated and biopsies taken.

University Hospital Ostrava

Antineoplastic Agents

Anti-Inflammatory Agents

Gastrointestinal Agents

Anticoagulants

Cisplatin

Fucoidan

Antacids

Anti-Ulcer Agents

Fucoidan powder at 4.4 g per sachet (dose) for oral administration. Fucoidan 4.4 g, PO, bid for 24 weeks

Potato starch at 4.4 g per sachet (dose) for oral administration. Potato starch 4.4 g, PO, bid for 24 weeks

Fucoidan refers to a class of fucose-enriched sulfated polysaccharides with an average molecular weight of 20,000 Daltons (Da), which can be found in many varieties of edible brown seaweeds and algae . In cell culture studies and animal studies, fucoidan has been shown to possess a range of biological activities, including anti-cancer, anti-inflammatory, and immunoregulatory effects . A recent in vitro study conducted in head and neck squamous cell carcinoma (HNSCC) cell lines (H103, FaDu, and KB) showed that fucoidan could induce cell cycle arrest and possibly apoptosis in a dose-dependent manner, while also enhancing response to cisplatin treatment . In addition, fucoidan has also been shown to inhibit the proliferation of nasopharyngeal carcinoma cells and MC3 human mucoepidermoid carcinoma (MEC) cells .

Placebo( Potato starch)

Christy Lee

Pei-Jen Lou

This phase II study is a randomized, double-blind study that seeks to evaluate the clinical effects and safety of fucoidan in the treatment of cancer patients with stage III/IV head and neck squamous cell carcinoma.

Patients will be centrally randomized in a 1:1 ratio to receive either Fucoidan or placebo (potato starch) Eligible subjects will receive fucoidan twice daily (BID) in combination with chemotherapy and radiation therapy over a 24-week treatment period.

Clinical effects and safety parameters for all subjects who complete the treatment period will be followed for an additional 72 weeks after the treatment period.

This phase II study is a randomized, double-blind study that seeks to evaluate the clinical effects and safety of fucoidan in the treatment of cancer patients with stage III/IV head and neck squamous cell carcinoma.

Patients will be centrally randomized in a 1:1 ratio to receive either Fucoidan or placebo (potato starch) Eligible subjects will receive fucoidan twice daily (BID) in combination with chemotherapy and radiation therapy over a 24-week treatment period.

Clinical effects and safety parameters for all subjects who complete the treatment period will be followed for an additional 72 weeks after the treatment period.

The total length of the study for each subject will be approximately 100 weeks, comprising the following time periods: screening period (28 days), treatment period (24 weeks), and follow-up period (72 weeks).

Fucoidan Group: Fucoidan 4.4 g, PO, bid for 24 weeks Placebo Group: Potato starch 4.4 g, PO, bid for 24 weeks

Patients will be centrally randomized in a 1:1 ratio to receive either Fucoidan or placebo (potato starch) Eligible subjects will receive fucoidan twice daily (BID) in combination with chemotherapy and radiation therapy over a 24-week treatment period.

A Randomized, Double-blind Study to Evaluate the Clinical Effect and Safety of Fucoidan in Patients With Squamous Cell Carcinomas of the Head and Neck

To evaluate the safety of fucoidan, as defined by the incidence of treatment-emergent adverse events (TEAEs)

To evaluate the quality of life (QoL) of patients treated with a combination of fucoidan, chemotherapy, and radiation therapy by using questionnaire: EuroQol five dimensions questionnaire (EQ5D)

To evaluate the quality of life (QoL) of patients treated with a combination of fucoidan, chemotherapy, and radiation therapy by using questionnaire: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module 35 (H\&N 35)

To evaluate disease-free survival (DFS) of patients treated with a combination of fucoidan, chemotherapy, and radiation therapy

To evaluate pain in patients treated with a combination of fucoidan, chemotherapy, and radiation therapy by a numerical rating scale (NRS: 0-10)

To evaluate the disease control rate (DCR) of patients treated with a combination of fucoidan, chemotherapy, and radiation therapy

Hi-Q Marine Biotech International, Ltd.

Micronutrients

Hematinics

Iron

Ferrosoferric Oxide

Parenteral Nutrition Solutions

On Day 1, patient will have 2 standard MRIs, as part of standard of care. About an hour after these 2 scans, patient receives ferumoxytol by vein. Right after that, first study MRI performed. The study MRI performed in the same way that a standard MRI is performed.

On Day 2, about 24 hours after patient receives ferumoxytol, second study MRI performed.

On Day 1, patient will have 2 standard MRIs, as part of standard of care. About an hour after these 2 scans, patient receives ferumoxytol by vein. Right after that, first study MRI performed. On Day 2, about 24 hours after patient receives ferumoxytol, second study MRI performed.

Magnetic Resonance Imaging (MRI)

On Day 1, patient will have 2 standard MRIs, as part of standard of care. About an hour after these 2 scans, patient receives ferumoxytol by vein.

Ferumoxytol

Clifton Fuller, MD

The goal of this clinical research study is to learn if ferumoxytol, when given at the time of a magnetic resonance imaging (MRI), can help researchers learn more about the spread of certain kinds of cancers.

Ferumoxytol is designed to deliver iron to treat iron-deficiency anemia (low red blood cell counts) in patients with chronic kidney disease. In this study, it will be used as an MRI contrast. Contrasts are used by doctors in order to see MRI images more clearly.

Study Scans:

If you are found to be eligible to take part in this study, you will have 2 study MRIs. These scans will be performed at the Center for Advanced Biomedical Imaging (CABI), in the South Campus Research Building at MD Anderson.

On Day 1, you will have 2 standard MRIs, as part of your standard of care. About an hour after these 2 scans, you will receive ferumoxytol by vein. Right after that, you will have your first study MRI. The study MRI will be performed in the same way that a standard MRI is performed.

On Day 2, about 24 and 72 hours after you receive ferumoxytol, you will have a second study MRI.

Additional Tests:

On Days 1 and 3, as well as 4 weeks after the first study MRI:

* You will have a physical exam.
* Blood (about 2 teaspoons) will be drawn for routine tests and/or to check your iron level.

On Day 2:

* You will have a physical exam.
* If you have not had one in the last month, you will have a PET-CT scan to check the status of the disease.

Length of Study:

You will be on study for about 4 weeks. You will be taken off study if you have intolerable side effects or you are unable to have the scans for any reason.

This is an investigational study. Ferumoxytol is commercially available and FDA-approved for the treatment of iron deficiency anemia.

Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.

Ferumoxytol - Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI

Pilot Feasibility Study of Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI for Primary and Nodal Tumor Imaging in Locally Advanced Head and Neck Squamous Cell Carcinomas

Feasibility defined as at least 15 (75%) patients finish the imaging process and good quality images obtained. Good quality image defined as subjective quality assessment score of 4 by two independent radiation oncologists and one radiologist for clinical usability for radiotherapy planning on a 5-point scale. The 5-point scale is defined with 0 implying unable to assess and 5 implying optimal image quality.

M.D. Anderson Cancer Center

Antibodies

Immunoglobulins

Mitogens

Zalutumumab

Antineoplastic Agents, Immunological

Radiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4) + Zalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose)

Radiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4)

Radiotherapy

Zalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose)

Jens Overgaard, Prof. MD

The purpose of this study is to determine whether the addition of the fully human EGFr antibody zalutumumab to primary curative radiotherapy increases locoregional control in Squamous Cell Carcinomas of the Head and Neck.

Radiotherapy to Squamous Cell Carcinomas of the Head and Neck have been modified during the last decades by altered fractionation, the addition of concomitant chemotherapy or modification of hypoxia. By these modifications the locoregional control, disease-specific survival or overall survival have been increased but the price have been increased morbidity.

The addition of antibodies against the Epidermal Growth Factor receptor (EGFR-I) may further increase the control and survival of patients with Squamous Cell Carcinomas of the Head and Neck when combined with radiotherapy and/or chemotherapy.

The aim of the present study is to determine whether

1. The addition af the EGFr-I zalutumumab increases locoregional control in Squamous Cell Carcinomas of the Head and Neck
2. Whether disease-specific survival or overall survival is improved by addition of zalutumumab
3. Whether the addition of zalutumumab to primary curative radiotherapy or chemoradiotherapy is feasible and tolerable
4. Acute and late toxicity to the treatment.

DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC

DAHANCA 19: A Randomized Study of the Importance of the EGFr-Inhibitor Zalutumumab for the Outcome After Primary Curative Radiotherapy for Squamous Cell Carcinoma of the Head and Neck

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma	NCT01783158	Squamous Cell C...	Esophagoscopy a...	18 Years - 65 Years	University Hospital Ostrava
A Randomized, Double-blind Study to Evaluate the Clinical Effect and Safety of Fucoidan in Patients With Squamous Cell Carcinomas of the Head and Neck	NCT04597476	Squamous Cell C...	Fucoidan Placebo( Potato...	20 Years - 75 Years	Hi-Q Marine Biotech International, Ltd.
Ferumoxytol - Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI	NCT01895829	Head and Neck C...	Magnetic Resona... Ferumoxytol	18 Years -	M.D. Anderson Cancer Center
Ferumoxytol - Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI	NCT01895829	Head and Neck C...	Magnetic Resona... Ferumoxytol	18 Years -	M.D. Anderson Cancer Center
DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC	NCT00496652	Cancer of the H...	Radiotherapy Zalutumumab	18 Years -	Danish Head and Neck Cancer Group
Ferumoxytol - Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI	NCT01895829	Head and Neck C...	Magnetic Resona... Ferumoxytol	18 Years -	M.D. Anderson Cancer Center
Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma	NCT01783158	Squamous Cell C...	Esophagoscopy a...	18 Years - 65 Years	University Hospital Ostrava

Spots Global Cancer Trial Database for squamous cell carcinomas of the head and neck