Short Course Radiation Therapy in Palliative Treatment

Short Course Accelerated Radiation Therapy in Palliative Treatment of Advanced Head and Neck Malignancies

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.

Study Overview

• Status: Completed
• Conditions: Palliative Care
• Intervention / Treatment: Radiation: Short course radiotherapy

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short course radiotherapy; The radiotherapy is delivered over two days with accelerated hypo-fractionation was delivered	Radiation: Short course radiotherapy; An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with metastatic or locally advanced head and neck cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum tolerated dose	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	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Alessio G. Morganti, MD, Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): June 23, 2017
• Last Update Submitted That Met QC Criteria: June 21, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: palliative care; pain; quality of life; radiotherapy; head and neck cancer
• Other Study ID Numbers: SHARON-H&N

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No