Palliative Short Course Accelerated Radiation Therapy for Advanced Thoracic Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 53
- Locations
- 2
- Primary Endpoint
- Maximum tolerated dose
Study Overview
Brief Summary
The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short course radiation therapy in patients with symptomatic advanced thoracic 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 advanced thoracic cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •histologically proven advanced thoracic 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) <3
Exclusion Criteria
- •prior radiotherapy to the same region
Arms & Interventions
Short course radiotherapy
The radiotherapy is delivered over 2 days with accelerated hypo-fractionation.
Intervention: Short course radiotherapy (Radiation)
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
- Acute toxicity(1 year)
- Quality of life(1 year)
- Pain relief(1 year)
- Late toxicity(1 year)
Investigators
Alessio Giuseppe Morganti
Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna