Radiotherapy in Palliation of Advanced Pelvic Cancer

Palliative Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03947268
• Other study ID #: SHARON PELVIS (phase II trial)
• Status: Completed
• Phase: N/A
• Start date: January 1, 2009
• Est. completion date: January 1, 2019

Study information

• Verified date: May 2019
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Palliative Care
• Pelvic Neoplasms

Intervention

Radiation:
• Short course radiotherapy
An accelerated hypo-fractionation 2D-radiotherapy is delivered for palliation in patients with advanced pelvic cancer.

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of symptoms [pain]	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	Incidence of Treatment-Emergent Adverse Events [Acute radiation toxicity]	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
Secondary	Incidence of Treatment-Emergent Adverse Events [Late radiation toxicity]	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
Secondary	Assessment of the Quality of life (QOL)	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