Radiotherapy in Palliation of Advanced Pelvic Cancer

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03947268

Enrollment

Registered

2019-05-13

Start date

2009-01-01

Completion date

2019-01-01

Last updated

2019-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Palliative Care

Keywords

palliative care, pelvic cancer, radiotherapy, pain, Quality of life

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.

Interventions

RADIATIONShort course radiotherapy

An accelerated hypo-fractionation 2D-radiotherapy is delivered for palliation in patients with advanced pelvic cancer.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Assessment of symptoms [pain]	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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026