Radiotherapy in Palliation of Advanced Pelvic Cancer

May 10, 2019 updated by: Alessio Giuseppe Morganti, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Short-course radiotherapy
The radiotherapy is delivered over 2 days with accelerated hypo-fractionation technique.
Radiation: Short course radiotherapy
An accelerated hypo-fractionation 2D-radiotherapy is delivered for palliation in patients with advanced pelvic cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 year]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Acute radiation toxicity]
Time Frame: 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).
1 year
Incidence of Treatment-Emergent Adverse Events [Late radiation toxicity]
Time Frame: 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).
1 year
Assessment of the Quality of life (QOL)
Time Frame: 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).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Alessio G. Morganti, MD, Radiation Oncology Center, S.Orsola-Malpighi Hospital, Bologna, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

May 9, 2019

First Submitted That Met QC Criteria

May 10, 2019

First Posted (Actual)

May 13, 2019

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 10, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHARON PELVIS (phase II trial)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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