Short Course Radiation Therapy in Palliative Treatment of Head and Neck Cancer

Not Applicable

• Conditions: Head and Neck Cancer; Radiotherapy; Palliative Care
• Interventions: Radiation: standard treatment; Radiation: short course treatment

• Registration Number: NCT03804073
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

Study Timeline

• Study Start: 2017-11-08
• Status Verified: 2019-01
• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-15
• Last Update Submitted: 2019-01-21
• Last Update Posted: 2019-01-23
• Primary Completion: 2022-11-08
• Study Completion: 2023-11-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard treatment	standard treatment	patients in this group are treated with 3000 cGy in 10 daily fraction
short course treatment	short course treatment	patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital; 🇮🇹 Bologna, BO, Italy