Palliative Care
Conditions
Keywords
palliative care, thoracic 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 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.
Interventions
RADIATIONShort course radiotherapy
An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with advanced thoracic cancer
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
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 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). |
Countries
Italy
Outcome results
None listed