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Clinical Trial
. 2018 Apr;38(4):2409-2414.
doi: 10.21873/anticanres.12491.

Phase I-II Study of Short-course Accelerated Radiotherapy (SHARON) for Palliation in Head and Neck Cancer

Eleonora Farina  1 , Jenny Capuccini  1 , Gabriella Macchia  2 , Luciana Caravatta  3 , Nam P Nguyen  4 , Silvia Cammelli  1 , Andrea Farioli  5 , Giuseppe Zanirato Rambaldi  6 , Savino Cilla  7 , Tigeneh Wondemagegnhu  8 , A F M Kamal Uddin  9 , Mostafà Aziz Sumon  10 , Domenico Genovesi  3 , Milly Buwenge  1 , Francesco Cellini  11 , Vincenzo Valentini  11 , Francesco Deodato  12 , Alessio G Morganti  1
Affiliations
Clinical Trial

Phase I-II Study of Short-course Accelerated Radiotherapy (SHARON) for Palliation in Head and Neck Cancer

Eleonora Farina et al. Anticancer Res. 2018 Apr.

Abstract

Aim: To determine the maximum tolerated dose (MTD) of a short-course accelerated radiotherapy and its feasibility for symptomatic palliation of advanced head and neck cancer or head and neck metastases from any primary site.

Patients and methods: A phase I trial in four dose-escalation steps was planned: total dose ranged between 14 and 20 Gy in a total of four fractions administered twice a day. The dose-limiting toxicity (DLT) was determined as grade 3 or more toxicity occurring during treatment. The MTD obtained was used to plan a phase II trial.

Results: A total of 48 patients were treated. In the phase I trial, the 20 Gy dose level was determined to be the MTD. In the phase II trial, the palliative response rate was 82.7%, with a median duration of palliation of 3 months.

Conclusion: Short-course accelerated radiotherapy was well tolerated and effective for palliation. These findings may help design future prospective randomized studies.

Keywords: Head and neck cancer; pain; palliative care; quality of life; radiotherapy.

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