NCT01023529

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

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

November 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

5.7 years

First QC Date

November 30, 2009

Last Update Submit

November 17, 2015

Conditions

Prostatic NeoplasmsRectal Neoplasms

Keywords

Prostatic NeoplasmsRectal NeoplasmsPalliative treatmentRadiotherapyQuality of life

Outcome Measures

Primary Outcomes (1)

  • Effect on patient's target symptom.

    at end of treatment and 6 weeks and 12 weeks after treatment completion

Secondary Outcomes (2)

  • Effect on patient's QoL.

    at end of treatment and 6 and 12 weeks after treatment completion.

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

    at end of treatment and 6 and 12 weeks after treatment completion.

Study Arms (2)

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)

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)

Interventions

Palliative pelvic soft-tissue radiation (external beam)RADIATION

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

Prostate cancerRectal Cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Stavanger University Hospital

Stavanger, Rogaland, Norway

Location

Ålesund Hospital

Ålesund, Norway

Location

Nordland Hospital, Bodø

Bodø, Norway

Location

Innlandet Hospital Trust, Gjøvik

Gjøvik, Norway

Location

Center for Cancer Treatment, Sorlandet Hospital HF

Kristiansand, 4604, Norway

Location

The Cancer Center, Ullevål University Hospital

Oslo, 0407, Norway

Location

University Hospital of Northern Norway (Tromsø)

Tromsø, Norway

Location

St. Olav's Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Prostatic NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 2, 2009

Study Start

November 1, 2009

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

NO(8)