Clinical trial NCT01023529: Symptoms and Quality of Life (QoL) After Palliative Pelvic Radiation of Prostate and Rectal Cancers
Official title: A Prospective Multicenter Study of Symptoms and QOL in Patients With Prostate and Rectal Cancers Receiving Palliative Pelvic Radiation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Rectal Neoplasms
Keywords: Prostatic Neoplasms
Rectal Neoplasms
Palliative treatment
Radiotherapy
Quality of life
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: Oslo University Hospital
name: Sykehuset Innlandet HF
name: Nordlandssykehuset HF
name: University Hospital of North Norway
name: Helse Stavanger HF
name: Alesund Hospital
name: Trondheim University Hospital
First posted: 2009-12-02
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Symptomatic patients referred for palliative pelvic radiotherapy of prostate and rectosigmoid cancers.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect on patient's target symptom.
timeFrame: at end of treatment and 6 weeks and 12 weeks after treatment completion
Secondary outcomes:
measure: Effect on patient's QoL.
timeFrame: at end of treatment and 6 and 12 weeks after treatment completion.
measure: Time to improvement in patient's symptoms and QoL.
timeFrame: at end of treatment and 6 and 12 weeks after treatment completion.
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
state: Rogaland
city: Bodø
country: Norway
facility: Nordland Hospital, Bodø
city: Gjøvik
country: Norway
facility: Innlandet Hospital Trust, Gjøvik
city: Kristiansand
country: Norway
facility: Center for Cancer Treatment, Sorlandet Hospital HF
city: Oslo
country: Norway
facility: The Cancer Center, Ullevål University Hospital
city: Tromsø
country: Norway
facility: University Hospital of Northern Norway (Tromsø)
city: Trondheim
country: Norway
facility: St. Olav's Hospital
city: Ålesund
country: Norway
facility: Ålesund Hospital
Study officials:
References: