Short Course Radiation Therapy in Palliative Treatment

Palliative Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196700
• Other study ID #: SHARON-H&N
• Status: Completed
• Phase: N/A
• First received: June 20, 2017
• Last updated: June 21, 2017
• Start date: January 1, 2009
• Est. completion date: June 1, 2017

Study information

• Verified date: June 2017
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Palliative Care

Intervention

Radiation:
• Short course radiotherapy
An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with metastatic or locally advanced head and neck cancer.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acute toxicity	Acute toxicity after treatment is evaluated with CTCAE scale	1 year
Secondary	Quality of life	Quality of life after the treatment is evaluated according to CLAS scale	1 year
Secondary	Pain relief	Pain after the therapy is evaluated with the visual analogic scale	1 year
Secondary	Late toxicity	Late toxicity after the treatment is evaluated with EORTC-RTOG scale	1 year