Clinical & Experimental Metastasis

, Volume 35, Issue 8, pp 739–746 | Cite as

Radiotherapy in palliation of thoracic tumors: a phase I–II study (SHARON project)

  • Eleonora Farina
  • Gabriella Macchia
  • Milly BuwengeEmail author
  • Giambattista Siepe
  • Alice Zamagni
  • Silvia Cammelli
  • Savino Cilla
  • Tigeneh Wondemagegnhu
  • Aynalem A. Woldemariam
  • A. F. M. Kamal Uddin
  • Mostafà Aziz Sumon
  • Francesco Cellini
  • Francesco Deodato
  • Alessio G. Morganti
Research Paper


The main clinical goal for patients with advanced or metastatic thoracic cancer is palliation of tumor-related symptoms and improvement of quality of life. The aim of this phase I–II trial was to define the maximum tolerated dose (MTD) of a short-course of palliative radiotherapy (RT) and to evaluate its efficacy in terms of palliative response. A phase I trial was planned with escalating dose increments. Total doses ranged from 16 to 20 Gy delivered (BID) in two consecutive days. Dose limiting toxicity was defined as any acute grade ≥ 3 toxicity based on the RTOG scale. MTD was used in the phase II trial to evaluate the efficacy of this regimen using a two stage Simon’s design. Fifty-four patients were enrolled. The upper dose level of 20 Gy was defined as the MTD. In patients treated with this dose, the overall palliative response rate was 96.5% (CI 0.95: 81.3–99.9%). Complete pain relief rate was 50.0%. Median survival without symptomatic progression was 3 months. The tested short course accelerated regimen was well tolerated and effective in the palliative setting of metastatic or locally advanced chest cancer. A phase III trial is ongoing to validate this RT schedule.

Trial registration: NCT03465553.


Lung cancer Radiotherapy Palliative care Pain Quality of life Phase I–II 



Clinical target volume


Computed tomography


Dose limiting toxicity


Dose-volume histograms


Gross tumor volume


Maximum tolerated dose


Non-small cell lung cancer


Organs at risk


Planning target volume


Quality of life




SHort course Accelerated RadiatiON therapy


Visual Analogue self-assessment Scale


Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interests.

Ethical approval

The study was approved by our institutional Ethics Committee in accordance with the Helsinki Declaration. All patients provided written informed consent before study entry.


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Copyright information

© Springer Nature B.V. 2018

Authors and Affiliations

  • Eleonora Farina
    • 1
  • Gabriella Macchia
    • 2
  • Milly Buwenge
    • 1
    Email author
  • Giambattista Siepe
    • 1
  • Alice Zamagni
    • 1
  • Silvia Cammelli
    • 1
  • Savino Cilla
    • 3
  • Tigeneh Wondemagegnhu
    • 4
  • Aynalem A. Woldemariam
    • 4
  • A. F. M. Kamal Uddin
    • 5
  • Mostafà Aziz Sumon
    • 5
  • Francesco Cellini
    • 6
  • Francesco Deodato
    • 2
  • Alessio G. Morganti
    • 1
  1. 1.Radiation Oncology Unit, Department of Experimental, Diagnostic and Specialty Medicine – DIMESUniversity of Bologna, S. Orsola-Malpighi HospitalBolognaItaly
  2. 2.Radiotherapy Unit, Department of Oncology“Giovanni Paolo II” Foundation, Catholic University of Sacred HeartCampobassoItaly
  3. 3.Medical Physics Unit, Department of Oncology“Giovanni Paolo II” Foundation, Catholic University of Sacred HeartCampobassoItaly
  4. 4.Department of RadiotherapyBlack Lion HospitalAddis-AbabaEthiopia
  5. 5.Department of Radiation OncologyUnited Hospital LimitedDhakaBangladesh
  6. 6.Department of Radiotherapy“A. Gemelli” Hospital, Catholic UniversityRomeItaly

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