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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01023529

Acronym

PallRad1

Enrollment

Registered

2009-12-02

Start date

2009-11-30

Completion date

2015-07-31

Last updated

2015-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms, Rectal Neoplasms

Keywords

Prostatic Neoplasms, Rectal Neoplasms, Palliative treatment, Radiotherapy, Quality of life

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.

Interventions

RADIATIONPalliative pelvic soft-tissue radiation (external beam)

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026