Clinical trial · Observational

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

NCT01023529CI-TRIAL-00019841PallRad1completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Prostatic Neoplasms	Prostate Neoplasm	ALIAS	0.90
Rectal Neoplasms	Rectal Neoplasm	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Palliative pelvic soft-tissue radiation (external beam)	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
Prostate cancer
description
Patients with incurable prostate cancer requiring palliation of symptoms from a soft-tissue pelvic tumor.
interventionNames
1. Radiation: Palliative pelvic soft-tissue radiation (external beam)
label
Rectal Cancer
description
Patients with incurable rectal cancer requiring palliation of symptoms from a soft-tissue pelvic tumor.
interventionNames
1. Radiation: Palliative pelvic soft-tissue radiation (external beam)

Primary outcomes (1)

measure
Effect on patient's target symptom.
timeFrame
at end of treatment and 6 weeks and 12 weeks after treatment completion

Secondary outcomes (2)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Nov 1, 2009
Primary completion: Jul 1, 2015
Completion: Jul 1, 2015
First posted: Dec 2, 2009
Last update posted: Nov 18, 2015
Enrollment: 98 (actual)
Lead sponsor: Sorlandet Hospital HF OTHER_GOV
Collaborators: Oslo University Hospital; Sykehuset Innlandet HF; Nordlandssykehuset HF; University Hospital of North Norway; Helse Stavanger HF; Alesund Hospital; Trondheim University Hospital
Keywords: Prostatic Neoplasms, Rectal Neoplasms, Palliative treatment, Radiotherapy, Quality of life

Data updated 22 days agoSource updated Nov 18, 2015source: clinicaltrials

Locations

Locations by country (8)

Country	Sites	Recruiting
Norway	8	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.