Short Course Radiation Therapy in Palliative Treatment of Head and Neck Cancer
SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Head and Neck Cancer: an Interventional, Randomized, Multicentric Study
1 other identifier
interventional
82
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable head-and-neck-cancer
Started Nov 2017
Longer than P75 for not_applicable head-and-neck-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 8, 2017
CompletedFirst Submitted
Initial submission to the registry
January 11, 2019
CompletedFirst Posted
Study publicly available on registry
January 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2023
CompletedJanuary 23, 2019
January 1, 2019
5 years
January 11, 2019
January 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of palliation using the short course scheme compared with the standard scheme
reduction of initial symptoms (pain, bleeding, dysphagia, hoarseness, stridor, dehydration, malnutrition) after radiotherapy, evaluated as none-mild-moderate-severe before and after treatment
3 months
Secondary Outcomes (3)
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 Arms (2)
standard treatment
ACTIVE COMPARATORpatients in this group are treated with 3000 cGy in 10 daily fraction
short course treatment
EXPERIMENTALpatients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)
Interventions
2000 cGy in 4 fractions administered twice a day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pregnancy
- previous irradiation of the same region
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
Bologna, BO, 40138, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alessio G Morganti, MD
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 11, 2019
First Posted
January 15, 2019
Study Start
November 8, 2017
Primary Completion
November 8, 2022
Study Completion
November 8, 2023
Last Updated
January 23, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share