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Clinical Trials/NCT03804073
NCT03804073
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SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Head and Neck Cancer: an Interventional, Randomized, Multicentric Study

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 site in 1 country82 target enrollmentNovember 8, 2017
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ConditionsHead and Neck CancerRadiotherapyPalliative Care

Overview

Phase
N/A
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Enrollment
82
Locations
1
Primary Endpoint
Efficacy of palliation using the short course scheme compared with the standard scheme
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic head and neck (H&N) malignant lesions

Detailed Description

Standard treatment for H\&N lesions (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (2000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme

Registry
clinicaltrials.gov
Start Date
November 8, 2017
End Date
November 8, 2023
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alessio Giuseppe Morganti

Professor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Eligibility Criteria

Inclusion Criteria

  • •symptomatic H\&N malignant lesions (primary solid tumors or metastases from solid tumor)
  • •age\>18 years
  • •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
  • •no changes in supportive care in the week before radiotherapy

Exclusion Criteria

  • •pregnancy
  • •previous irradiation of the same region

Outcomes

Primary Outcomes

Efficacy of palliation using the short course scheme compared with the standard scheme

Time Frame: 3 months

reduction of initial symptoms (pain, bleeding, dysphagia, hoarseness, stridor, dehydration, malnutrition) after radiotherapy, evaluated as none-mild-moderate-severe before and after treatment

Secondary Outcomes

  • acute toxicity in the two treatment groups(3 months)
  • late toxicity in the two treatment groups(12 months)
  • Quality of Life (QoL) assessment in the two groups(12 months)

Study Sites (1)

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