Status:
COMPLETED
Patient Selection for Hypoxia Modifying Treatments in Larynx Carcinomas
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Dutch Cancer Society
Conditions:
Larynx Cancer
Eligibility:
All Genders
18+ years
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 ra...
Detailed Description
Purpose Prognostic indicators discriminate patients with good and bad prognosis. Predictive assays are tools that select patients for specific treatments or treatment modifications such that outcome ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 1 2001
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00160095
Start Date
July 1 2001
End Date
March 1 2013
Last Update
May 7 2015
Active Locations (5)
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1
Free University Medical Centre Amsterdam
Amsterdam, Netherlands, po 7057 1007 MB
2
Rijnstate Ziekenhuis Arnhem
Arnhem, Netherlands, po 9555 6800 TA
3
Academic Hospital Maastricht
Maastricht, Netherlands, po 5800 6202 AZ
4
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB