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

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Abstract

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.

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Abbreviations

CTV:

Clinical target volume

CT:

Computed tomography

DLT:

Dose limiting toxicity

DVH:

Dose-volume histograms

GTV:

Gross tumor volume

MTD:

Maximum tolerated dose

NSCLC:

Non-small cell lung cancer

OaR:

Organs at risk

PTV:

Planning target volume

QoL:

Quality of life

RT:

Radiotherapy

SHARON:

SHort course Accelerated RadiatiON therapy

VAS:

Visual Analogue self-assessment Scale

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Author information

Author notes

  1. Francesco Deodato and Alessio G. Morganti have contributed equally.

Authors and Affiliations

  1. Radiation Oncology Unit, Department of Experimental, Diagnostic and Specialty Medicine – DIMES, University of Bologna, S. Orsola-Malpighi Hospital, via Giuseppe Massarenti 9, 40138, Bologna, Italy

    Eleonora Farina, Milly Buwenge, Giambattista Siepe, Alice Zamagni, Silvia Cammelli & Alessio G. Morganti

  2. Radiotherapy Unit, Department of Oncology, “Giovanni Paolo II” Foundation, Catholic University of Sacred Heart, Campobasso, Italy

    Gabriella Macchia & Francesco Deodato

  3. Medical Physics Unit, Department of Oncology, “Giovanni Paolo II” Foundation, Catholic University of Sacred Heart, Campobasso, Italy

    Savino Cilla

  4. Department of Radiotherapy, Black Lion Hospital, Addis-Ababa, Ethiopia

    Tigeneh Wondemagegnhu & Aynalem A. Woldemariam

  5. Department of Radiation Oncology, United Hospital Limited, Dhaka, Bangladesh

    A. F. M. Kamal Uddin & Mostafà Aziz Sumon

  6. Department of Radiotherapy, “A. Gemelli” Hospital, Catholic University, Rome, Italy

    Francesco Cellini

Authors
  1. Eleonora Farina
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  2. Gabriella Macchia
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  3. Milly Buwenge
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  4. Giambattista Siepe
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  5. Alice Zamagni
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  6. Silvia Cammelli
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  7. Savino Cilla
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  8. Tigeneh Wondemagegnhu
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  9. Aynalem A. Woldemariam
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  10. A. F. M. Kamal Uddin
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  11. Mostafà Aziz Sumon
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  12. Francesco Cellini
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  13. Francesco Deodato
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  14. Alessio G. Morganti
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Corresponding author

Correspondence to Milly Buwenge.

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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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Farina, E., Macchia, G., Buwenge, M. et al. Radiotherapy in palliation of thoracic tumors: a phase I–II study (SHARON project). Clin Exp Metastasis 35, 739–746 (2018). https://doi.org/10.1007/s10585-018-9942-6

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  • DOI: https://doi.org/10.1007/s10585-018-9942-6

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