Phase III randomised trialReduction of the dose of radiotherapy to the elective neck in head and neck squamous cell carcinoma; a randomized clinical trial. Effect on late toxicity and tumor control
Section snippets
Material and methods
A prospective randomized multicenter non-inferiority phase III study was set up between 6 centers. Inclusion criteria were previously untreated, histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx or cervical lymph node metastases of unknown primary cancer (CUP). Patient work-up was done according to institutional guidelines. T1–T2N0 were allowed, if prophylactic neck irradiation was performed. Patients were older than 18 years with a Karnofsky
Patients
Between May 2008 and May 2011, 200 patients were included and randomized. Treatment characteristics of 7 patients could not be retrieved before close-out date of this analysis, yielding 193 patients for analysis (96 in the experimental arm and 97 in control arm). Patient characteristics are depicted in Table 1.
The study included 83 patients with an oropharyngeal tumor; 41 in the 40 Gy and 42 in the 50 Gy arm. 17 patients (20,5%) of these 83 patients had an HPV positive tumor; 60 patients (72,5%)
Discussion
In this paper we describe the late toxicity and outcome of a multicenter randomized controlled trial reducing the dose to the elective lymph nodes in patients treated for head and neck cancer.
The primary endpoint of this study was late dysphagia as this is the most important quality of life compromising toxicity after curative treatment of HNC [2]. Altered fractionation schedules, concomitant chemotherapy and oropharyngeal tumor location are associated with more dysphagia [6]. With the
Conclusions
Dose de-escalation to the elective nodal volume in HNC from a 50 to a 40 Gy-equivalent dose results in a trend toward less dysphagia at 6 months and less moderate salivary gland toxicity without significant differences in disease control or survival.
Conflict of interest
None of the authors has a conflict of interest in connection with the paper and the material is not under publication or consideration for publication elsewhere.
Acknowledgments
The project was funded by Kom Op Tegen Kanker. Study organization and data collection were performed by Rita Aerts.
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