Palliative Short-course Radiotherapy in Advanced Pelvic Cancer: a Phase II Study (SHARON Project)

IRCCS Azienda Ospedaliero-Universitaria di Bologna0 sites25 target enrollmentJanuary 1, 2009

ConditionsPalliative Care

Overview

Phase: N/A
Intervention: Not specified
Conditions: Palliative Care
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Enrollment: 25
Primary Endpoint: Assessment of symptoms [pain]
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2009

End Date

January 1, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Responsible Party

Principal Investigator

Alessio Giuseppe Morganti

Professor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Eligibility Criteria

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

Outcomes

Primary Outcomes

Assessment of symptoms [pain]

Time Frame: 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 Outcomes

Incidence of Treatment-Emergent Adverse Events [Acute radiation toxicity](1 year)
Incidence of Treatment-Emergent Adverse Events [Late radiation toxicity](1 year)
Assessment of the Quality of life (QOL)(1 year)