Short Course Radiation Therapy in Palliative Treatment

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Completed

Conditions: Palliative Care

Treatments: Radiation: Short course radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03196700

SHARON-H&N

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Short course radiotherapy

Experimental group

Description:

The radiotherapy is delivered over two days with accelerated hypo-fractionation was delivered

Treatment:

Radiation: Short course radiotherapy