Prostatic NeoplasmsPallRad1NCT01023529
Symptoms and Quality of Life (QoL) After Palliative Pelvic Radiation of Prostate and Rectal Cancers
An observational study of Prostatic Neoplasms and Rectal Neoplasms, run by Sorlandet Hospital HF at 8 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostatic Neoplasms, Rectal Neoplasms
- What is being tested?
- Palliative pelvic soft-tissue radiation (external beam)
- Type of treatment
- Surgery or procedure
- How many people
- 98 participants
- Where
- 8 sitesNorway
- Study dates
- Nov 2009to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic patients referred for palliative pelvic radiotherapy of prostate and rectosigmoid cancers.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
Norway8 sites
Ålesund Hospital
Ålesund
Nordland Hospital, Bodø
Bodø
Innlandet Hospital Trust, Gjøvik
Gjøvik
Center for Cancer Treatment, Sorlandet Hospital HF
Kristiansand, 4604
The Cancer Center, Ullevål University Hospital
Oslo, 0407
Stavanger University Hospital
Stavanger, Rogaland
University Hospital of Northern Norway (Tromsø)
Tromsø
St. Olav's Hospital
Trondheim
About this study
Official title: A Prospective Multicenter Study of Symptoms and QOL in Patients With Prostate and Rectal Cancers Receiving Palliative Pelvic Radiation
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.
Read the 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.
- Conditions
- Prostatic Neoplasms, Rectal Neoplasms
- Being tested
- Palliative pelvic soft-tissue radiation (external beam)
- Keywords
- Prostatic Neoplasms, Rectal Neoplasms, Palliative treatment, Radiotherapy, Quality of life
- Medical subject headings
- Prostatic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative pelvic soft-tissue radiation (external beam)Radiation
3 Gy x 10-13 (range 30 - 39 Gy total)
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer | Patients with incurable prostate cancer requiring palliation of symptoms from a soft-tissue pelvic tumor. Receives: Radiation: Palliative pelvic soft-tissue radiation (external beam) | |
| Rectal Cancer | Patients with incurable rectal cancer requiring palliation of symptoms from a soft-tissue pelvic tumor. Receives: Radiation: Palliative pelvic soft-tissue radiation (external beam) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on patient's target symptom.
Measured: at end of treatment and 6 weeks and 12 weeks after treatment completion
Secondary outcomes (2)
Effect on patient's QoL.
Measured: at end of treatment and 6 and 12 weeks after treatment completion.
Time to improvement in patient's symptoms and QoL.
Measured: at end of treatment and 6 and 12 weeks after treatment completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- Oslo University Hospital, Sykehuset Innlandet HF, Nordlandssykehuset HF, University Hospital of North Norway, Helse Stavanger HF, Alesund Hospital, Trondheim University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023529
- Sponsor's protocol ID
- 2009-1684(REK)
- Acronym
- PallRad1
- Status last verified
- Nov 2015
- First submitted
- 30 Nov 2009
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study of Symptoms and QOL in Patients With Prostate and Rectal Cancers Receiving Palliative Pelvic Radiation
- ClinicalTrials.gov ID
- NCT01023529
- Acronym / sponsor ID
- PallRad1 / 2009-1684(REK)
- Conditions
- Prostatic Neoplasms, Rectal Neoplasms
- Keywords
- Prostatic Neoplasms, Rectal Neoplasms, Palliative treatment, Radiotherapy, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- Oslo University Hospital, Sykehuset Innlandet HF, Nordlandssykehuset HF, University Hospital of North Norway, Helse Stavanger HF, Alesund Hospital, Trondheim University Hospital
- Study start
- Nov 2009
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer | – | Radiation: Palliative pelvic soft-tissue radiation (external beam)Patients with incurable prostate cancer requiring palliation of symptoms from a soft-tissue pelvic tumor. |
| Rectal Cancer | – | Radiation: Palliative pelvic soft-tissue radiation (external beam)Patients with incurable rectal cancer requiring palliation of symptoms from a soft-tissue pelvic tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic patients referred for palliative pelvic radiotherapy of prostate and rectosigmoid cancers.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative pelvic soft-tissue radiation (external beam)3 Gy x 10-13 (range 30 - 39 Gy total) | Radiation | Prostate cancer, Rectal Cancer |
Primary outcome
Effect on patient's target symptom.
Time frame: at end of treatment and 6 weeks and 12 weeks after treatment completion
2 secondary outcomes
Effect on patient's QoL.
Time frame: at end of treatment and 6 and 12 weeks after treatment completion.
Time to improvement in patient's symptoms and QoL.
Time frame: at end of treatment and 6 and 12 weeks after treatment completion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms and Rectal Neoplasms, run by Sorlandet Hospital HF at 8 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on patient's target symptom. (time frame: at end of treatment and 6 weeks and 12 weeks after treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.