Short Course Radiation Therapy in Palliative Treatment of Pelvic Cancer

Palliative Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03804333
• Other study ID #: RT 15-04 SHARON PELVIS
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2017
• Est. completion date: November 8, 2023

Study information

• Verified date: January 2019
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: Alessio G Morganti, MD
• Phone: 0512143564
• Email: alessio.morganti2[@]unibo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: November 8, 2023
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Palliative Care
• Pelvic Cancer
• Pelvic Neoplasms
• Radiotherapy

Intervention

Radiation:
• standard treatment
3000 cGy in 10 daily fractions
• short course treatment
2000 cGy in 4 fractions administered twice a day

Locations

Country	Name	City	State
Italy	Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of palliation using the short course scheme compared with the standard scheme: Likert scale	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	acute toxicity in the two treatment groups	incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria (RTOG)	3 months
Secondary	late toxicity in the two treatment groups	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
Secondary	Quality of Life (QoL) assessment in the two groups: EORTC questionnaire C15-PAL	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