Skip to main content
OpenTrials
Completed

NCT Number: NCT03196700

Short Course Radiation Therapy in Palliative Treatment

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Palliative Care Head and Neck Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Short Course Radiotherapy

Radiation

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

Primary outcomes

  1. Maximum tolerated dose

    Time frame: 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 outcomes

  1. Acute toxicity

    Time frame: 1 year

    Acute toxicity after treatment is evaluated with CTCAE scale

  2. Quality of life

    Time frame: 1 year

    Quality of life after the treatment is evaluated according to CLAS scale

  3. Pain relief

    Time frame: 1 year

    Pain after the therapy is evaluated with the visual analogic scale

  4. Late toxicity

    Time frame: 1 year

    Late toxicity after the treatment is evaluated with EORTC-RTOG scale

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Jun 23, 2017
Registry last updated
Jun 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.