Symptoms and Quality of Life (QoL) After Palliative Pelvic Radiation of Prostate and Rectal Cancers
Conditions
Prostatic Neoplasms - Rectal Neoplasms
Conditions: official terms
Neoplasms - Prostatic Neoplasms - Rectal Neoplasms
Conditions: Keywords
Prostatic Neoplasms, Rectal Neoplasms, Palliative treatment, Radiotherapy, Quality of life
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Intervention
Name: Palliative pelvic soft-tissue radiation (external beam)
Type: Radiation
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Stavanger University Hospital
Stavanger, Rogaland, Norway
Status: Recruiting
Contact: Trond Aagedal, MD - trond.aagedal@sus.no
Nordland Hospital, Bodø
Bodø, Norway
Status: Recruiting
Contact: Carsten Nieder, MD PhD - Carsten.Nieder@nordlandssykehuset.no
Innlandet Hospital Trust, Gjøvik
Gjøvik, Norway
Status: Recruiting
Contact: Kjetil Weyde, MD - Kjetil.Weyde@sykehuset-innlandet.no
Center for Cancer Treatment, Sorlandet Hospital HF
Kristiansand, Norway
Status: Recruiting
Contact: Christian Kersten, MD PhD - Christian.Kersten@sshf.no
The Cancer Center, Ullevål University Hospital
Oslo, Norway
Status: Recruiting
Contact: Marianne G Guren, MD PhD - marianne.guren@medisin.uio.no
University Hospital of Northern Norway (Tromsø)
Tromsø, Norway
Status: Recruiting
Contact: Ola Magne Vagnildhaug, MD - Ola.Magne.Vagnildhaug@unn.no
St. Olav's Hospital
Trondheim, Norway
Status: Recruiting
Contact: Ingunn Hatlevold, MD - ingunn.hatlevold@stolav.no
Ålesund Hospital
Ålesund, Norway
Status: Recruiting
Contact: Tatiana M Abramova, MD - Tatiana.Mikhailovna.Abramova@else-mr.no
Start Date
November 2009
Sponsors
Sorlandet Hospital HF
Source
Sorlandet Hospital HF
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page