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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03804073

Enrollment

Registered

2019-01-15

Start date

2017-11-08

Completion date

2023-11-08

Last updated

2019-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Palliative Care, Radiotherapy

Keywords

Short Course Radiotherapy, Symptomatic head and neck lesions

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

Interventions

RADIATIONstandard treatment

3000 cGy in 10 daily fractions

RADIATIONshort course treatment

2000 cGy in 4 fractions administered twice a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy of palliation using the short course scheme compared with the standard scheme	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

Measure	Time frame	Description
acute toxicity in the two treatment groups	3 months	incidence of treatment-related acute adverse events in the two arms of the study registered using Radiation Therapy Oncology Group (RTOG) Cooperative Group Common Toxicity Criteria
late toxicity in the two treatment groups	12 months	incidence of treatment-related adverse events in the two arms of the study registered using RTOG/European Organisation for Research and Treatment of Cancer(EORTC) Late Radiation Morbility Scoring Schema
Quality of Life (QoL) assessment in the two groups	12 months	changes in QoL after treatment assessed using a specific EORTC questionnaire developed to assess the quality of life of palliative cancer care patients (C15-PAL)

Countries

Italy

Contacts

Primary ContactAlessio G Morganti, MD

alessio.morganti2@unibo.it0512143564

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026