Short Course Radiation Therapy in Palliative Treatment

Not Applicable

Completed

• Conditions: Palliative Care
• Interventions: Radiation: Short course radiotherapy

• Registration Number: NCT03196700
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short course radiation treatment in patients with symptomatic advanced head and neck cancer.

Detailed Description

The study wants to define the maximum tolerated dose (MTD) of a conformal short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days, and the feasibility of this fractionation in term of safety and efficacy for symptomatic palliation of metastatic or locally advanced head and neck cancer.

Study Timeline

• Study Start: 2009-01-01
• Primary Completion: 2017-01-01
• Status Verified: 2017-06
• Study Completion: 2017-06-01
• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-21
• Last Update Submitted: 2017-06-21
• Study First Posted: 2017-06-23
• Last Update Posted: 2017-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• histologically proven locally advanced or metastatic H&N cancer
• excluded from curative therapy because of disease stage and/or presence of multiple comorbidities and/or poor performance status
• age > 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status < 3

Exclusion Criteria

• prior RT to the same region.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Short course radiotherapy	Short course radiotherapy	The radiotherapy is delivered over two days with accelerated hypo-fractionation was delivered

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose	1 year	The maximum tolerated dose is defined as the dose level below the highest administered dose associated with dose limiting toxicity (DLT) in at least one third of patients

Secondary Outcome Measures

Name	Time	Method
Quality of life	1 year	Quality of life after the treatment is evaluated according to CLAS scale
Late toxicity	1 year	Late toxicity after the treatment is evaluated with EORTC-RTOG scale
Pain relief	1 year	Pain after the therapy is evaluated with the visual analogic scale
Acute toxicity	1 year	Acute toxicity after treatment is evaluated with CTCAE scale