Skip to main content
OpenTrials
Completed

NCT Number: NCT01023529

Symptoms and Quality of Life (QoL) After Palliative Pelvic Radiation of Prostate and Rectal Cancers

The purpose of this study is to assess the effect of palliative pelvic radiation on symptoms and quality of life among patients with incurable prostate and rectal cancer.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stavanger University Hospital, Stavanger, Rogaland, Norway

Loading trial locations.

About this study

With the aging population, the prevalence of cancer is on the rise, leading to an increased demand for effective palliative treatment. There is little scientific information describing the effects of palliative radiotherapy among patients treated for soft-tissue tumors of the pelvis. This is a treatment that is used relatively frequently, but delivered heterogeneously since the optimum fractionation schedule has yet to be established. This study aims to define the effects of one such fractionation schedule (3Gy x 10-13) and thus, establish a foundation for future fractionation studies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Histologically or cytologically proven adenocarcinoma of the prostate or rectosigmoid colon.
  • Incurable disease (hormone-resistant in cases of prostate cancer)
  • Life expectancy > 3 months
  • Symptomatic soft-tissue pelvic tumor mass (primary, recurrence or metastases)
  • Planned fractionated radiotherapy (3Gy x 10-13)
  • Written informed consent

Exclusion criteria

  • Unable to fill out questionnaires (due to language or cognitive barriers)
  • New systemic tumor-targeted treatment (hormone manipulation, chemotherapy, monoclonal antibodies, etc.) started within four weeks of baseline or during the 6 weeks immediately following pelvic radiotherapy.
  • Previous pelvic radiotherapy
  • The presence of a second primary pelvic cancer or other cancer requiring treatment
  • Currently receiving treatment with an investigational drug

Treatment and study plan

Palliative pelvic soft-tissue radiation (external beam)

Radiation

3 Gy x 10-13 (range 30 - 39 Gy total)

Primary outcomes

  1. Effect on patient's target symptom.

    Time frame: at end of treatment and 6 weeks and 12 weeks after treatment completion

Secondary outcomes

  1. Effect on patient's QoL.

    Time frame: at end of treatment and 6 and 12 weeks after treatment completion.

  2. Time to improvement in patient's symptoms and QoL.

    Time frame: at end of treatment and 6 and 12 weeks after treatment completion.

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Collaborators

  • Alesund Hospital
  • Helse Stavanger HF
  • Nordlandssykehuset HF
  • Oslo University Hospital
  • Sykehuset Innlandet HF
  • Trondheim University Hospital
  • University Hospital of North Norway

Registry information

Official study title

A Prospective Multicenter Study of Symptoms and QOL in Patients With Prostate and Rectal Cancers Receiving Palliative Pelvic Radiation

Acronym: PallRad1

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Dec 2, 2009
Registry last updated
Nov 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.