Short Course Radiation Therapy in Palliative Treatment

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03196700

Enrollment

Registered

2017-06-23

Start date

2009-01-01

Completion date

2017-06-01

Last updated

2017-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Palliative Care

Keywords

palliative care, head and neck cancer, radiotherapy, pain, quality of life

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.

Interventions

RADIATIONShort course radiotherapy

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026