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

Sorlandet Hospital HF

Status: Completed

Conditions: Prostatic Neoplasms; Rectal Neoplasms

Treatments: Radiation: Palliative pelvic soft-tissue radiation (external beam)

Study type: Observational

Funder types: Other

Identifiers

NCT01023529

2009-1684(REK)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

98 participants in 2 patient groups

Prostate cancer

Description:

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

Treatment:

Radiation: Palliative pelvic soft-tissue radiation (external beam)

Rectal Cancer

Description:

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

Treatment:

Radiation: Palliative pelvic soft-tissue radiation (external beam)