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A Multicentre, Randomised, Phase III Clinical Trial Comparing Accelerated Radiotherapy With Accelerated Radiotherapy Plus Carbogen and Nicotinamide (ARCON) in Clinical Stage T2-4 Laryngeal Carcinoma.


Phase 3
19 Years
N/A
Open (Enrolling)
Both
Larynx Carcinoma

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Trial Information

A Multicentre, Randomised, Phase III Clinical Trial Comparing Accelerated Radiotherapy With Accelerated Radiotherapy Plus Carbogen and Nicotinamide (ARCON) in Clinical Stage T2-4 Laryngeal Carcinoma.


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 (appendix II).

- Age > 18 years.

- Written informed consent.

- Quality of life questionnaire completed.

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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local control

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Johannes HA Kaanders, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radboud University

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

098

NCT ID:

NCT00147732

Start Date:

April 2001

Completion Date:

February 2013

Related Keywords:

  • Larynx Carcinoma
  • larynx carcinoma
  • radiotherapy
  • carbogen
  • nicotinamide
  • Carcinoma
  • Laryngeal Diseases
  • Laryngeal Neoplasms

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