Patient Selection for Hypoxia Modifying Treatments in Larynx Carcinomas

This study is currently recruiting participants.

Verified by Radboud University, May 2008

Sponsors and Collaborators:	Radboud University Dutch Cancer Society
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00160095

Purpose

The purpose of this study is to identify in a prospective manner microregional profiles of oxygenation and proliferation based on exogenous and endogenous markers that are predictive for outcome of radiotherapy in squamous cell carcinoma of the larynx and to investigate if these profiles can identify patients that are most likely to benefit from hypoxia modifying treatment strategies like ARCON (Accelerated radiotherapy combined with carbogen breathing and nicotinamide).

Condition	Phase
Larynx Cancer	Phase III

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Patient Selection for Hypoxia Modifying Treatments Based on Functional Microregional Imaging of Tumor Vasculature, Oxygenation and Proliferation in Squamous Cell Carcinoma of the Larynx

Further study details as provided by Radboud University:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Tumor biopsies

Estimated Enrollment:	175
Study Start Date:	July 2001
Estimated Study Completion Date:	January 2010

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Squamous cell carcinoma of the larynx

Criteria

Inclusion Criteria:

Pathological confirmed squamous cell carcinoma of the larynx.
TNM-classification (UICC 1997, appendix I):
T3-4 glottic or supraglottic carcinoma
T2 glottic carcinoma with impaired cord mobility or subglottic extension
T2 supraglottic carcinoma with invasion of mucosa of base of tongue or vallecula or invasion of the medial wall of the piriform sinus.
any N-stage, M0.
WHO performance status 0 or 1.
Age > 18 years.
Written informed consent.
Treatment in the ARCON phase III trial

Exclusion Criteria:

Prior or concurrent treatment for this tumour.
Severe stridor and adequate debulking of airway not possible.
Impaired renal function: serum creatinine above upper normal limit.
Use of nefrotoxic medication (including ACE-inhibitors) that cannot be discontinued for the duration of the radiation treatment.
Impaired hepatic function: ASAT and ALAT more than 1.5 times the upper normal limit.
Use of anti-convulsants that cannot be discontinued for the duration of the radiation treatment.
History of malignancy during the previous 5 years except basal cell carcinoma of skin, carcinoma in situ of the cervix, or superficial bladder neoplasm (pTa).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160095

Contacts

Contact: Ilse J Hoogsteen, M.D.	+31243614515	i.hoogsteen@rther.umcn.nl
Contact: Johannes HA Kaanders, M.D., Ph.D.	+31243614515	j.kaanders@rther.umcn.nl

Locations

Netherlands
Radboud University Nijmegen Medical Centre	Recruiting
Nijmegen, Netherlands, 6500 HB
Contact: Ilse J Hoogsteen, M.D. +31243614515 i.hoogsteen@rther.umcn.nl
Contact: Johannes HA Kaanders, M.D., Ph.D. +31243614515 j.kaanders@rther.umcn.nl
Principal Investigator: Johannes HA Kaanders, M.D., Ph.D.
Universitair Medisch Centrum Utrecht	Recruiting
Utrecht, Netherlands, po 85500 3508 GA
Contact: C HJ Terhaard, M.D., Ph.D. +3130256110 c.h.j.terhaard@azu.nl
Sub-Investigator: C HJ Terhaard, M.D., Ph.D.
Free University Medical Centre Amsterdam	Recruiting
Amsterdam, Netherlands, po 7057 1007 MB
Contact: R de Bree, M.D., Ph.D. +31204443690 r.bree@vumc.nl
Sub-Investigator: R de Bree, M.D., Ph.D.
Academic Hospital Maastricht	Recruiting
Maastricht, Netherlands, po 5800 6202 AZ
Contact: M Lacko, M.D. +31433876543 m.lacko@skno.azm.nl
Sub-Investigator: M Lacko, M.D.
Rijnstate Ziekenhuis Arnhem	Recruiting
Arnhem, Netherlands, po 9555 6800 TA
Contact: H Bouman, M.D. +31263786256 hbouman@alysis.nl
Sub-Investigator: H Bouman, M.D.

Sponsors and Collaborators

Radboud University

Dutch Cancer Society

Investigators

Principal Investigator:

Johannes HA Kaanders, M.D., Ph.D.

Radboud University Nijmegen Medical Centre, Dept Radiation Oncology

More Information

Responsible Party:	Radboud University Medical Centre ( Prof. J. Kaanders )
Study ID Numbers:	088, KUN 2003-2899
Study First Received:	September 9, 2005
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00160095
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:

larynx carcinoma
Tumor hypoxia
microregional imaging
hypoxia modifying treatment

Study placed in the following topic categories:

Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Squamous cell carcinoma
Laryngeal Neoplasms
Carcinoma
Anoxia
Epidermoid carcinoma
Signs and Symptoms

Respiratory Tract Diseases
Head and Neck Neoplasms
Carcinoma, squamous cell
Laryngeal carcinoma
Signs and Symptoms, Respiratory
Laryngeal Diseases
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009