Symptoms and Quality of Life (QoL) After Palliative Pelvic Radiation of Prostate and Rectal Cancers (PallRad1)

November 17, 2015 updated by: Sorlandet Hospital HF

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bodø, Norway
        • Nordland Hospital, Bodø
      • Gjøvik, Norway
        • Innlandet Hospital Trust, Gjøvik
      • Kristiansand, Norway, 4604
        • Center for Cancer Treatment, Sorlandet Hospital HF
      • Oslo, Norway, 0407
        • The Cancer Center, Ullevål University Hospital
      • Tromsø, Norway
        • University Hospital of Northern Norway (Tromsø)
      • Trondheim, Norway
        • St. Olav's Hospital
      • Ålesund, Norway
        • Ålesund Hospital
    • Rogaland
      • Stavanger, Rogaland, Norway
        • Stavanger University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Symptomatic patients referred for palliative pelvic radiotherapy of prostate and rectosigmoid cancers.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prostate cancer
Patients with incurable prostate cancer requiring palliation of symptoms from a soft-tissue pelvic tumor.
Radiation: Palliative pelvic soft-tissue radiation (external beam)
3 Gy x 10-13 (range 30 - 39 Gy total)
Rectal Cancer
Patients with incurable rectal cancer requiring palliation of symptoms from a soft-tissue pelvic tumor.
Radiation: Palliative pelvic soft-tissue radiation (external beam)
3 Gy x 10-13 (range 30 - 39 Gy total)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect on patient's target symptom.
Time Frame: at end of treatment and 6 weeks and 12 weeks after treatment completion
at end of treatment and 6 weeks and 12 weeks after treatment completion

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect on patient's QoL.
Time Frame: at end of treatment and 6 and 12 weeks after treatment completion.
at end of treatment and 6 and 12 weeks after treatment completion.
Time to improvement in patient's symptoms and QoL.
Time Frame: at end of treatment and 6 and 12 weeks after treatment completion.
at end of treatment and 6 and 12 weeks after treatment completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sorlandet Hospital HF

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

November 30, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (Estimate)

December 2, 2009

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-1684(REK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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