Short Course Accelerated Radiation Therapy in Palliative Treatment of Advanced Head and Neck Malignancies
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Palliative Care
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Enrollment
- 48
- Primary Endpoint
- Maximum tolerated dose
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Alessio Giuseppe Morganti
Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
- Quality of life(1 year)
- Late toxicity(1 year)
- Pain relief(1 year)
- Acute toxicity(1 year)