Palliative CareNCT03947268
Radiotherapy in Palliation of Advanced Pelvic Cancer
A study testing Short course radiotherapy in people with Palliative Care, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
Trial summary
The study wants to define the safety and efficacy of a short-course radiation therapy in patients with symptomatic advanced pelvic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- Short course radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 1 Jan 2019
- Phase
- Interventional
- 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
Who may be able to join
- histologically proven advanced pelvic cancer
- excluded from curative therapy because of disease stage and/or presence of multiple comorbidities and/or poor performance status
- age > 18 years
- Eastern Cooperative Oncology Group (ECOG) <3
Who cannot join
- prior radiotherapy to the same region
About this study
Official title: Palliative Short-course Radiotherapy in Advanced Pelvic Cancer: a Phase II Study (SHARON Project)
The study wants to define the safety and efficacy of a short-course radiation therapy in patients with symptomatic advanced pelvic cancer.
Read the detailed description
he study wants to define the safety and efficacy of a short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days for symptomatic palliation of advanced solid cancer.
- Conditions
- Palliative Care
- Being tested
- Short course radiotherapy
- Keywords
- palliative care, pelvic cancer, radiotherapy, pain, Quality of life
- Medical subject headings
- Pelvic Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short course radiotherapyRadiation
An accelerated hypo-fractionation 2D-radiotherapy is delivered for palliation in patients with advanced pelvic cancer.
| Study group | Role | What they receive |
|---|---|---|
| Short-course radiotherapy | Experimental | The radiotherapy is delivered over 2 days with accelerated hypo-fractionation technique. Receives: Radiation: Short course radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of symptoms [pain]
Pain after treatment is evaluated with the Visual Analogic scale (VAS). Values range from 0 (no pain) to 10 (maximum possible pain).
Measured: 1 year]
Secondary outcomes (3)
Incidence of Treatment-Emergent Adverse Events [Acute radiation toxicity]
Acute toxicity after treatment is evaluated with the Common Terminology Criteria for Adverse Events (CTCAE). Values range from 1 (minimum acute toxicity) to 5 (maximum acute toxicity).
Measured: 1 year
Incidence of Treatment-Emergent Adverse Events [Late radiation toxicity]
Late toxicity after the treatment is evaluated with the Toxicity criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC). Values range from 1 (minimum late toxicity) to 5 (maximum/severe late toxicity).
Measured: 1 year
Assessment of the Quality of life (QOL)
Quality of life after the treatment is evaluated according with the Cancer Linear Analog Scale (CLAS). CLAS scale evaluates well-being, fatigue, and ability to perform daily activities. This method is based on a linear analogue scale. Values range from 0 (better status) to 10 (worst status).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start1 Jan 2009
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessio Giuseppe Morganti, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Alessio G. Morganti, MD, Principal investigator, Radiation Oncology Center, S.Orsola-Malpighi Hospital, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947268
- Sponsor's protocol ID
- SHARON PELVIS (phase II trial)
- Status last verified
- May 2019
- First submitted
- 9 May 2019
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Short-course Radiotherapy in Advanced Pelvic Cancer: a Phase II Study (SHARON Project)
- ClinicalTrials.gov ID
- NCT03947268
- Acronym / sponsor ID
- SHARON PELVIS (phase II trial)
- Conditions
- Palliative Care
- Keywords
- palliative care, pelvic cancer, radiotherapy, pain, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 13 May 2019 (actual)
- 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 study wants to define the safety and efficacy of a short-course radiation therapy in patients with symptomatic advanced pelvic cancer.
Detailed description
he study wants to define the safety and efficacy of a short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days for symptomatic palliation of advanced solid cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Short-course radiotherapy | Experimental | Radiation: Short course radiotherapyThe radiotherapy is delivered over 2 days with accelerated hypo-fractionation technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- histologically proven advanced pelvic cancer
- excluded from curative therapy because of disease stage and/or presence of multiple comorbidities and/or poor performance status
- age > 18 years
- Eastern Cooperative Oncology Group (ECOG) <3
Key exclusion criteria (1 listed)
- prior radiotherapy to the same region
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 |
|---|---|---|
| Short course radiotherapyAn accelerated hypo-fractionation 2D-radiotherapy is delivered for palliation in patients with advanced pelvic cancer. | Radiation | Short-course radiotherapy |
Primary outcome
Assessment of symptoms [pain]
Time frame: 1 year]
Pain after treatment is evaluated with the Visual Analogic scale (VAS). Values range from 0 (no pain) to 10 (maximum possible pain).
3 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Acute radiation toxicity]
Time frame: 1 year
Incidence of Treatment-Emergent Adverse Events [Late radiation toxicity]
Time frame: 1 year
Assessment of the Quality of life (QOL)
Time frame: 1 year
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 14 May 2019.
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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.
Alessio G. Morganti, MD principal investigator
Radiation Oncology Center, S.Orsola-Malpighi Hospital, Bologna, Italy
Questions about this trial
What is this clinical trial studying?
A study testing Short course radiotherapy in people with Palliative Care, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
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 4 inclusion and 1 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 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Assessment of symptoms [pain] (time frame: 1 year]). 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 14 May 2019.