Short Course Radiation Therapy in Palliative Treatment of Pelvic Cancer

January 14, 2019 updated by: Alessio Giuseppe Morganti, IRCCS Azienda Ospedaliero-Universitaria di Bologna

SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Pelvic Cancer: an Interventional, Randomized, Multicentric Study

Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic pelvic malignant lesions

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

standard treatment for pelvic lesions (300 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (2000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40138
        • Recruiting
        • Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital

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:

  • symptomatic pelvic malignant lesions (primary solid tumors or metastases from solid tumor)
  • age > 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
  • no changes in supportive care in the week before radiotherapy

Exclusion Criteria:

  • pregnancy
  • previous irradiation of 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: short course treatment
patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)
Radiation: short course treatment
2000 cGy in 4 fractions administered twice a day
Active Comparator: standard treatment
patients in this group are treated with 3000 cGy in 10 daily fractions
Radiation: standard treatment
3000 cGy in 10 daily fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy of palliation using the short course scheme compared with the standard scheme: Likert scale
Time Frame: 3 months
reduction of initial symptoms after radiotherapy, assessed with Likert scale (pain, bleeding, diarrhoea, bowel obstruction, polyuria, urinary obstruction, dysuria, lymphedema, vaginal discharge are evaluated as none-mild-moderate-severe)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute toxicity in the two treatment groups
Time Frame: 3 months
incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria (RTOG)
3 months
late toxicity in the two treatment groups
Time Frame: 12 months
incidence of treatment-related adverse events in the two arms of the study registered using RTOG/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbility Scoring Schema
12 months
Quality of Life (QoL) assessment in the two groups: EORTC questionnaire C15-PAL
Time Frame: 12 months
changes in QoL after treatment assessed using EORTC questionnaire C15-PAL (a specific questionnaire from EORTC developed to assess the QoL of palliative cancer care patients)
12 months

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, Dept of Experimental, Diagnostic and Speciality Medicine-DIMES, University of Bologna, S.Orsola-Malpighi Hospital

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)

November 8, 2017

Primary Completion (Anticipated)

November 8, 2022

Study Completion (Anticipated)

November 8, 2023

Study Registration Dates

First Submitted

January 11, 2019

First Submitted That Met QC Criteria

January 14, 2019

First Posted (Actual)

January 15, 2019

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT 15-04 SHARON PELVIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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