Radiotherapy in Palliation of Advanced Pelvic Cancer

Not Applicable

Completed

• Conditions: Palliative Care
• Interventions: Radiation: Short course radiotherapy

• Registration Number: NCT03947268
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

The study wants to define the safety and efficacy of a short-course radiation therapy in patients with symptomatic advanced pelvic cancer.

Detailed Description

he study wants to define the safety and efficacy of a short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days for symptomatic palliation of advanced solid cancer.

Study Timeline

• Study Start: 2009-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Status Verified: 2019-05
• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-10
• Last Update Submitted: 2019-05-10
• Study First Posted: 2019-05-13
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• histologically proven advanced pelvic 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

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 technique.

Primary Outcome Measures

Name	Time	Method
Assessment of symptoms [pain]	1 year]	Pain after treatment is evaluated with the Visual Analogic scale (VAS). Values range from 0 (no pain) to 10 (maximum possible pain).

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Acute radiation 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).
Incidence of Treatment-Emergent Adverse Events [Late radiation 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).
Assessment of the Quality of life (QOL)	1 year	Quality of life after the treatment is evaluated according with the Cancer Linear Analog Scale (CLAS). CLAS scale evaluates well-being, fatigue, and ability to perform daily activities. This method is based on a linear analogue scale. Values range from 0 (better status) to 10 (worst status).