Patient Selection for Hypoxia Modifying Treatments in Larynx Carcinomas

NCT00160095 | Completed

• 2 other identifiers: 088KUN 2003-2899
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 5

Brief Summary

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).

Conditions

Larynx Cancer

Keywords

larynx carcinoma; Tumor hypoxia; microregional imaging; hypoxia modifying treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Squamous cell carcinoma of the larynx

You may qualify if:

• 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

You may not qualify if:

• 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 nephrotoxic 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).

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Dutch Cancer Society: collaborator

Study Sites (5)

Free University Medical Centre Amsterdam

Amsterdam, po 7057 1007 MB, Netherlands

Location

Rijnstate Ziekenhuis Arnhem

Arnhem, po 9555 6800 TA, Netherlands

Location

Academic Hospital Maastricht

Maastricht, po 5800 6202 AZ, Netherlands

Location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, po 85500 3508 GA, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor biopsies

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Study Officials

• Johannes HA Kaanders, M.D., Ph.D.

  Radboud University Nijmegen Medical Centre, Dept Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 12, 2005
• Study Start: July 1, 2001
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2013
• Last Updated: May 7, 2015

Record last verified: 2015-05

Locations

NL (5)