Palliative CareNCT03196700
Short Course Radiation Therapy in Palliative Treatment
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 maximum tolerated dose (MTD), safety and efficacy of a short course radiation treatment in patients with symptomatic advanced head and neck 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
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 1 Jun 2017
- 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 locally advanced or metastatic H\&N 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) performance status < 3
Who cannot join
- prior RT to the same region.
About this study
Official title: Short Course Accelerated Radiation Therapy in Palliative Treatment of Advanced Head and Neck Malignancies
The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short course radiation treatment in patients with symptomatic advanced head and neck cancer.
Read the detailed description
The study wants to define the maximum tolerated dose (MTD) of a conformal short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days, and the feasibility of this fractionation in term of safety and efficacy for symptomatic palliation of metastatic or locally advanced head and neck cancer.
- Conditions
- Palliative Care
- Being tested
- Short course radiotherapy
- Keywords
- palliative care, head and neck cancer, radiotherapy, pain, quality of life
- Medical subject headings
- Head and Neck 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 radiotherapy is delivered for palliation in patients with metastatic or locally advanced head and neck cancer.
| Study group | Role | What they receive |
|---|---|---|
| Short course radiotherapy | Experimental | The radiotherapy is delivered over two days with accelerated hypo-fractionation was delivered Receives: Radiation: Short course radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
The maximum tolerated dose is defined as the dose level below the highest administered dose associated with dose limiting toxicity (DLT) in at least one third of patients
Measured: 1 year
Secondary outcomes (4)
Acute toxicity
Acute toxicity after treatment is evaluated with CTCAE scale
Measured: 1 year
Quality of life
Quality of life after the treatment is evaluated according to CLAS scale
Measured: 1 year
Pain relief
Pain after the therapy is evaluated with the visual analogic scale
Measured: 1 year
Late toxicity
Late toxicity after the treatment is evaluated with EORTC-RTOG scale
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 posted23 Jun 2017
- Study start1 Jan 2009
- Primary completion1 Jan 2017
- Study completion1 Jun 2017
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
- 48 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, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196700
- Sponsor's protocol ID
- SHARON-H&N
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2017
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Course Accelerated Radiation Therapy in Palliative Treatment of Advanced Head and Neck Malignancies
- ClinicalTrials.gov ID
- NCT03196700
- Acronym / sponsor ID
- SHARON-H&N
- Conditions
- Palliative Care
- Keywords
- palliative care, head and neck cancer, radiotherapy, pain, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 23 Jun 2017 (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 maximum tolerated dose (MTD), safety and efficacy of a short course radiation treatment in patients with symptomatic advanced head and neck cancer.
Detailed description
The study wants to define the maximum tolerated dose (MTD) of a conformal short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days, and the feasibility of this fractionation in term of safety and efficacy for symptomatic palliation of metastatic or locally advanced head and neck 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 two days with accelerated hypo-fractionation was delivered |
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 locally advanced or metastatic H\&N 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) performance status < 3
Key exclusion criteria (1 listed)
- prior RT 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 radiotherapy is delivered for palliation in patients with metastatic or locally advanced head and neck cancer. | Radiation | Short course radiotherapy |
Primary outcome
Maximum tolerated dose
Time frame: 1 year
The maximum tolerated dose is defined as the dose level below the highest administered dose associated with dose limiting toxicity (DLT) in at least one third of patients
4 secondary outcomes
Acute toxicity
Time frame: 1 year
Quality of life
Time frame: 1 year
Pain relief
Time frame: 1 year
Late toxicity
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 23 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, 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 23 Jun 2017. 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?
Maximum tolerated dose (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 23 Jun 2017.