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

Completed

• Conditions: Prostatic Neoplasms; Rectal Neoplasms
• Interventions: Radiation: Palliative pelvic soft-tissue radiation (external beam)

• Registration Number: NCT01023529
• Lead Sponsor: Sorlandet Hospital HF

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.

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prostate cancer	Palliative pelvic soft-tissue radiation (external beam)	Patients with incurable prostate cancer requiring palliation of symptoms from a soft-tissue pelvic tumor.
Rectal Cancer	Palliative pelvic soft-tissue radiation (external beam)	Patients with incurable rectal cancer requiring palliation of symptoms from a soft-tissue pelvic tumor.

Primary Outcome Measures

Name	Time	Method
Effect on patient's target symptom.	at end of treatment and 6 weeks and 12 weeks after treatment completion

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (8)

Innlandet Hospital Trust, Gjøvik; 🇳🇴 Gjøvik, Norway

University Hospital of Northern Norway (Tromsø); 🇳🇴 Tromsø, Norway

Stavanger University Hospital; 🇳🇴 Stavanger, Rogaland, Norway

Center for Cancer Treatment, Sorlandet Hospital HF; 🇳🇴 Kristiansand, Norway

The Cancer Center, Ullevål University Hospital; 🇳🇴 Oslo, Norway

Ålesund Hospital; 🇳🇴 Ålesund, Norway

Nordland Hospital, Bodø; 🇳🇴 Bodø, Norway

St. Olav's Hospital; 🇳🇴 Trondheim, Norway