A Prospective Multicenter Study of Symptoms and QOL in Patients With Prostate and Rectal Cancers Receiving Palliative Pelvic Radiation
18 Years
N/A
Both
Prostatic Neoplasms, Rectal Neoplasms
Trial Information
A Prospective Multicenter Study of Symptoms and QOL in Patients With Prostate and Rectal Cancers Receiving Palliative Pelvic Radiation
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.
Inclusion 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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Effect on patient's target symptom.
Outcome Time Frame:
at end of treatment and 6 weeks and 12 weeks after treatment completion
Safety Issue:
No
Authority:
Norway:National Committee for Medical and Health Research Ethics
Study ID:
2009-1684(REK)
NCT ID:
NCT01023529
Start Date:
November 2009
Completion Date:
Related Keywords:
- Prostatic Neoplasms
- Rectal Neoplasms
- Prostatic Neoplasms
- Rectal Neoplasms
- Palliative treatment
- Radiotherapy
- Quality of life
- Neoplasms
- Rectal Neoplasms
- Prostatic Neoplasms
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