Advertisement

Topics

A Post-marketing Surveillance Study of Erbitux (Cetuximab) in Combination With Radiotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

2014-08-27 03:15:29 | BioPortfolio

Summary

Prospective, observational, multicentre post-marketing surveillance study to mainly collect safety information from subjects with locally advanced HNSCC treated with Erbitux in combination with radiotherapy based on the locally approved label.

Description

Erbitux is an immunoglobulin G1 (IgG1) monoclonal antibody that enhances the effects of some common chemotherapy agents and radiotherapy and demonstrates minimal overlapping toxicities with these approaches. This prospective, observational, non-interventional and multi-centric post marketing surveillance study is being conducted to collect safety information from subjects with locally advanced HNSCC treated with Erbitux based on the locally approved label. Study plans to enroll 150-200 subjects, who are eligible for Erbitux treatment according to the indication in the approved label of Erbitux by Taiwan Health Authority. Data related to subjects' demographics, relevant tumour history, and laboratory information (hematology, biochemistry) will be captured and analysed descriptively.

OBJECTIVES

Primary objective:

- To obtain safety information on the use of Erbitux combined with radiotherapy in subjects with locally advanced HNSCC

Secondary objectives:

- To gather clinical efficacy information of the treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Head and Neck Squamous Cell Carcinoma

Intervention

Cetuximab

Location

Liouying Chi-Mei Hospital
Liouying
Tainan County
Taiwan

Status

Not yet recruiting

Source

Merck KGaA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:29-0400

Clinical Trials [4023 Associated Clinical Trials listed on BioPortfolio]

Ficlatuzumab With or Without Cetuximab in Treating Patients With Cetuximab-Resistant, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This randomized phase II trial studies how well ficlatuzumab with or without cetuximab work in treating patients with head and neck squamous cell carcinoma that has come back or spread to ...

Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer

The purpose of this study is to determine whether the combination of palbociclib with cetuximab is superior to cetuximab in prolonging overall survival in HPV-negative, cetuximab-naive pat...

Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck

The primary objectives of this study are to determine the 1-year progression-free survival (PFS) of previously irradiated patients with squamous cell carcinoma of the head and neck (SCCHN)...

Weekly Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Docetaxel and cetuximab are FDA approved for the treatment of squamous cell carcinoma of the head and neck. Cisplatin and carboplatin, while not FDA approved for Squamous Cell Carcinoma of...

Image Guided Intensity Modulated Reirradiation (IG-IMRT) With Cetuximab for Locoregionally Confined Recurrent Head and Neck Squamous Cell Carcinoma

The standard treatment for head and neck cancer relapses in previously irradiated patients is controversial. Reirradiation has had some success, but many patients still die from their dis...

PubMed Articles [19574 Associated PubMed Articles listed on BioPortfolio]

Cisplatin versus cetuximab with definitive concurrent radiotherapy for head and neck squamous cell carcinoma: An analysis of veterans health affairs data.

The addition of cisplatin or cetuximab to radiation therapy (RT) improves outcomes in comparison with RT alone in the nonoperative management of head and neck squamous cell carcinoma (HNSCC), but limi...

Maintenance Therapy with Biweekly Cetuximab: Optimizing Schedule Can Preserve Activity and Improves Compliance in Advanced Head and Neck Cancer.

This study evaluates maintenance cetuximab administered every 2 weeks (q2w) after chemotherapy plus cetuximab as first-line treatment in a series of patients with head and neck squamous cell cancer an...

Effect of statin use on oncologic outcomes in head and neck squamous cell carcinoma.

Preclinical and early-phase clinical studies have suggested an oncoprotective role of statins in head and neck squamous cell carcinoma (HNSCC). The purpose of this study was to determine whether incid...

Incidence of second primary cancers after radiotherapy combined with platinum and/or cetuximab in head and neck cancer patients.

The second primary cancer (SPC) incidence after treatment with platinum-based chemotherapy and cetuximab in combination with radiotherapy has not been previously reported. Our aim was to compare SPC r...

Combined Metabolo-Volumetric Parameters of F-FDG-PET and MRI Can Predict Tumor Cellularity, Ki67 Level and Expression of HIF 1alpha in Head and Neck Squamous Cell Carcinoma: A Pilot Study.

Our purpose was to evaluate associations of combined F-FDG-PET and MRI parameters with histopathological features in head and neck squamous cell carcinoma (HNSCC).

Medical and Biotech [MESH] Definitions

Unusual tumor affecting any site of the body, but most often encountered in the head and neck. Considerable debate has surrounded the histogenesis of this neoplasm; however, it is considered to be a myoblastoma of, usually, a benign nature. It affects women more often than men. When it develops beneath the epidermis or mucous membrane, it can lead to proliferation of the squamous cells and mimic squamous cell carcinoma.

A carcinoma arising from MERKEL CELLS located in the basal layer of the epidermis and occurring most commonly as a primary neuroendocrine carcinoma of the skin. Merkel cells are tactile cells of neuroectodermal origin and histologically show neurosecretory granules. The skin of the head and neck are a common site of Merkel cell carcinoma, occurring generally in elderly patients. (Holland et al., Cancer Medicine, 3d ed, p1245)

A carcinoma derived from stratified squamous epithelium. It may also occur in sites where glandular or columnar epithelium is normally present. (From Stedman, 25th ed)

A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.

A mixed adenocarcinoma and squamous cell or epidermoid carcinoma.

More From BioPortfolio on "A Post-marketing Surveillance Study of Erbitux (Cetuximab) in Combination With Radiotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Antibodies
An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Diagnostics
A diagnostic test is any kind of medical test performed to aid in the diagnosis or detection of disease. For example: to diagnose diseases to measure the progress or recovery from disease to confirm that a person is free from disease Clin...


Searches Linking to this Trial