Status:
COMPLETED
Randomized Trial of ARCON in Larynx Cancer
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Dutch Cancer Society
Conditions:
Larynx Carcinoma
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
TITLE: A multicentre, randomised, phase III clinical trial comparing accelerated radiotherapy with accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in clinical stage T2-4 laryngeal car...
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 (appendix II).
- Age \> 18 years.
- Written informed consent.
- Quality of life questionnaire completed.
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 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).
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT00147732
Start Date
April 1 2001
End Date
April 1 2013
Last Update
May 7 2015
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Free University Medical Centre
Amsterdam, Netherlands
2
University Medical Centre Groningen
Groningen, Netherlands
3
Leids University Medical Centre
Leiden, Netherlands
4
Maastro Clinic
Maastricht, Netherlands