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

NCT ID: NCT01023529

Last Updated: 2015-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Prostatic Neoplasms Rectal Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Prostate cancer

Patients with incurable prostate cancer requiring palliation of symptoms from a soft-tissue pelvic tumor.

Palliative pelvic soft-tissue radiation (external beam)

Intervention Type RADIATION

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.

Palliative pelvic soft-tissue radiation (external beam)

Intervention Type RADIATION

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

Interventions

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Palliative pelvic soft-tissue radiation (external beam)

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role collaborator

Nordlandssykehuset HF

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role collaborator

Alesund Hospital

OTHER

Sponsor Role collaborator

Trondheim University Hospital

OTHER

Sponsor Role collaborator

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stavanger University Hospital

Stavanger, Rogaland, Norway

Site Status

Ålesund Hospital

Ålesund, , Norway

Site Status

Nordland Hospital, Bodø

Bodø, , Norway

Site Status

Innlandet Hospital Trust, Gjøvik

Gjøvik, , Norway

Site Status

Center for Cancer Treatment, Sorlandet Hospital HF

Kristiansand, , Norway

Site Status

The Cancer Center, Ullevål University Hospital

Oslo, , Norway

Site Status

University Hospital of Northern Norway (Tromsø)

Tromsø, , Norway

Site Status

St. Olav's Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2009-1684(REK)

Identifier Type: -

Identifier Source: org_study_id