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

Study Overview
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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.

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

Conditions
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Prostatic Neoplasms, Rectal Neoplasms

Intervention / Treatment
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* Radiation: Palliative pelvic soft-tissue radiation (external beam)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prostate cancer<br>Patients with incurable prostate cancer requiring palliation of symptoms from a soft-tissue pelvic tumor. | Radiation: Palliative pelvic soft-tissue radiation (external beam)<br>* 3 Gy x 10-13 (range 30 - 39 Gy total)<br>|
| Rectal Cancer<br>Patients with incurable rectal cancer requiring palliation of symptoms from a soft-tissue pelvic tumor. | Radiation: Palliative pelvic soft-tissue radiation (external beam)<br>* 3 Gy x 10-13 (range 30 - 39 Gy total)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on patient's target symptom. |  | at end of treatment and 6 weeks and 12 weeks after treatment completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on patient's QoL. |  | at end of treatment and 6 and 12 weeks after treatment completion. | 
| Time to improvement in patient's symptoms and QoL. |  | at end of treatment and 6 and 12 weeks after treatment completion. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatic Neoplasms, Rectal Neoplasms, Palliative treatment, Radiotherapy, Quality of life