Palliative Short Course Radiotherapy for Advanced Thoracic Cancer

IRCCS Azienda Ospedaliero-Universitaria di Bologna53 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Palliative Care

Interventions

Short course radiotherapyRADIATION

An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with advanced thoracic cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Radiation Oncology Center, Dept. of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital

Bologna, Italy

Outcomes

Primary Outcomes

Maximum tolerated dose

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

Time frame: 1 year

Secondary Outcomes

Acute toxicity

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).

Time frame: 1 year

Quality of life

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).

Time frame: 1 year

Pain relief

Pain after treatment is evaluated with the Visual Analogic scale (VAS). Values range from 0 (no pain) to 10 (maximum possible pain).

Time frame: 1 year

Late toxicity

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).

Time frame: 1 year

Data from ClinicalTrials.gov

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