Palliative Short Course Radiotherapy for Advanced Thoracic Cancer
- Conditions
- Palliative Care
- Interventions
- Radiation: Short course radiotherapy
- Registration Number
- NCT03465553
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- 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
- prior radiotherapy to the same region
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Short course radiotherapy Short course radiotherapy The radiotherapy is delivered over 2 days with accelerated hypo-fractionation.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Acute toxicity 1 year Acute toxicity after treatment is evaluated with the Common Terminology Criteria for Adverse Events (CTCAE). Values range from 1 (minimum acute toxicity) to 5 (maximum acute toxicity).
Quality of life 1 year Quality of life after the treatment is evaluated according with the Cancer Linear Analog Scale (CLAS). Values range from 0 (better status) to 10 (worst status).
Pain relief 1 year Pain after treatment is evaluated with the Visual Analogic scale (VAS). Values range from 0 (no pain) to 10 (maximum possible pain).
Late toxicity 1 year Late toxicity after the treatment is evaluated with the Toxicity criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC). Values range from 1 (minimum late toxicity) to 5 (maximum/severe late toxicity).
Trial Locations
- Locations (1)
Radiation Oncology Center, Dept. of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital
🇮🇹Bologna, Italy