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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 Buwenge
  • 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

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.

Keywords

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

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

Notes

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
  • 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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