NCT03804333

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 8, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2023

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

5 years

First QC Date

January 11, 2019

Last Update Submit

January 14, 2019

Conditions

Pelvic CancerRadiotherapyPalliative Care

Keywords

short course radiotherapysymptomatic pelvic lesions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • acute toxicity in the two treatment groups

    3 months

  • late toxicity in the two treatment groups

    12 months

  • Quality of Life (QoL) assessment in the two groups: EORTC questionnaire C15-PAL

    12 months

Study Arms (2)

standard treatment

ACTIVE COMPARATOR

patients in this group are treated with 3000 cGy in 10 daily fractions

Radiation: standard treatment

short course treatment

EXPERIMENTAL

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

Interventions

standard treatmentRADIATION

3000 cGy in 10 daily fractions

standard treatment
short course treatmentRADIATION

2000 cGy in 4 fractions administered twice a day

short course treatment

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy
  • previous irradiation of the same region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bologna, BO, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Pelvic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Alessio G Morganti, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessio G Morganti, MD

CONTACT

0512143564alessio.morganti2@unibo.it

Study Design

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

Study Record Dates

First Submitted

January 11, 2019

First Posted

January 15, 2019

Study Start

November 8, 2017

Primary Completion

November 8, 2022

Study Completion

November 8, 2023

Last Updated

January 15, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)