NCT03947268

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
Last Updated

May 14, 2019

Status Verified

May 1, 2019

Enrollment Period

10 years

First QC Date

May 9, 2019

Last Update Submit

May 10, 2019

Conditions

Palliative Care

Keywords

palliative carepelvic cancerradiotherapypainQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Incidence of Treatment-Emergent Adverse Events [Acute radiation toxicity]

    1 year

  • Incidence of Treatment-Emergent Adverse Events [Late radiation toxicity]

    1 year

  • Assessment of the Quality of life (QOL)

    1 year

Study Arms (1)

Short-course radiotherapy

EXPERIMENTAL

The radiotherapy is delivered over 2 days with accelerated hypo-fractionation technique.

Radiation: Short course radiotherapy

Interventions

Short course radiotherapyRADIATION

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

Short-course radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- prior radiotherapy to the same region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pelvic NeoplasmsPain

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alessio G. Morganti, MD

    Radiation Oncology Center, S.Orsola-Malpighi Hospital, Bologna, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 13, 2019

Study Start

January 1, 2009

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

May 14, 2019

Record last verified: 2019-05