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

Prostatic Neoplasms Clinical Trial

— PallRad1  

Official title:

A Prospective Multicenter Study of Symptoms and QOL in Patients With Prostate and Rectal Cancers Receiving Palliative Pelvic Radiation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023529
• Other study ID #: 2009-1684(REK)
• Status: Completed
• Phase: N/A
• First received: November 30, 2009
• Last updated: November 17, 2015
• Start date: November 2009
• Est. completion date: July 2015

Study information

• Verified date: November 2015
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neoplasms
• Prostatic Neoplasms
• Rectal Neoplasms

Intervention

Radiation:
• Palliative pelvic soft-tissue radiation (external beam)
3 Gy x 10-13 (range 30 - 39 Gy total)

Locations

Country	Name	City	State
Norway	Ålesund Hospital	Ålesund
Norway	Nordland Hospital, Bodø	Bodø
Norway	Innlandet Hospital Trust, Gjøvik	Gjøvik
Norway	Center for Cancer Treatment, Sorlandet Hospital HF	Kristiansand
Norway	The Cancer Center, Ullevål University Hospital	Oslo
Norway	Stavanger University Hospital	Stavanger	Rogaland
Norway	University Hospital of Northern Norway (Tromsø)	Tromsø
Norway	St. Olav's Hospital	Trondheim

Sponsors (8)

Lead Sponsor	Collaborator
Sorlandet Hospital HF	Alesund Hospital, Helse Stavanger HF, Nordlandssykehuset HF, Oslo University Hospital, Sykehuset Innlandet HF, Trondheim University Hospital, University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on patient's target symptom.		at end of treatment and 6 weeks and 12 weeks after treatment completion	No
Secondary	Effect on patient's QoL.		at end of treatment and 6 and 12 weeks after treatment completion.	No
Secondary	Time to improvement in patient's symptoms and QoL.		at end of treatment and 6 and 12 weeks after treatment completion.	No