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

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: Prostatic Neoplasms; Rectal Neoplasms
• Intervention / Treatment: Radiation: Palliative pelvic soft-tissue radiation (external beam)

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

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

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

How is the study designed?

Number of groups / cohorts

2

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.	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.	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.

Collaborators and Investigators

• 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

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: Quality of life; Radiotherapy; Prostatic Neoplasms; Palliative treatment; Rectal Neoplasms
• Additional Relevant MeSH Terms: Digestive System Diseases; Urogenital Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Genital Neoplasms, Male; Prostatic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Neoplasms; Prostatic Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 2009-1684(REK)