PallRad1: Symptoms and Quality of Life (QoL) After Palliative Pelvic Radiation of Prostate and Rectal Cancers

• Sponsor: Sorlandet Hospital HF (Other)
• Overall Status: Completed
• CT.gov ID: NCT01023529
• Collaborator: Oslo University Hospital (Other), Sykehuset Innlandet HF (Other), Nordlandssykehuset HF (Other), University Hospital of North Norway (Other), Helse Stavanger HF (Other), Alesund Hospital (Other), Trondheim University Hospital (Other)
• Enrollment: 98
• Locations: 8
• Duration (Months): 67.9
• Patients Per Site: 12.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms; Rectal Neoplasms	Radiation: Palliative pelvic soft-tissue radiation (external beam)

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 98 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Prospective Multicenter Study of Symptoms and QOL in Patients With Prostate and Rectal Cancers Receiving Palliative Pelvic Radiation
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Prostate cancer Patients with incurable prostate cancer requiring palliation of symptoms from a soft-tissue pelvic tumor.	Radiation: Palliative pelvic soft-tissue radiation (external beam); 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.	Radiation: Palliative pelvic soft-tissue radiation (external beam); 3 Gy x 10-13 (range 30 - 39 Gy total)

Outcome Measures

Primary Outcome Measures

1. Effect on patient's target symptom. [at end of treatment and 6 weeks and 12 weeks after treatment completion]

Secondary Outcome Measures

1. Effect on patient's QoL. [at end of treatment and 6 and 12 weeks after treatment completion.]

2. Time to improvement in patient's symptoms and QoL. [at end of treatment and 6 and 12 weeks after treatment completion.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stavanger University Hospital	Stavanger	Rogaland	Norway
2	Nordland Hospital, Bodø	Bodø		Norway
3	Innlandet Hospital Trust, Gjøvik	Gjøvik		Norway
4	Center for Cancer Treatment, Sorlandet Hospital HF	Kristiansand		Norway	4604
5	The Cancer Center, Ullevål University Hospital	Oslo		Norway	0407
6	University Hospital of Northern Norway (Tromsø)	Tromsø		Norway
7	St. Olav's Hospital	Trondheim		Norway
8	Ålesund Hospital	Ålesund		Norway

Sponsors and Collaborators

• Sorlandet Hospital HF
• Oslo University Hospital
• Sykehuset Innlandet HF
• Nordlandssykehuset HF
• University Hospital of North Norway
• Helse Stavanger HF
• Alesund Hospital
• Trondheim University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sorlandet Hospital HF
• ClinicalTrials.gov Identifier: NCT01023529
• Other Study ID Numbers: 2009-1684(REK)
• First Posted: Dec 2, 2009
• Last Update Posted: Nov 18, 2015
• Last Verified: Nov 1, 2015

• Keywords provided by Sorlandet Hospital HF: Prostatic Neoplasms; Rectal Neoplasms; Palliative treatment; Radiotherapy; Quality of life
• Additional relevant MeSH terms: Neoplasms; Rectal Neoplasms; Prostatic Neoplasms

Study Results

No Results Posted as of Nov 18, 2015