Head and Neck CancerNCT03804073
Short Course Radiation Therapy in Palliative Treatment of Head and Neck Cancer
A study testing standard treatment and short course treatment in people with Head and Neck Cancer and Radiotherapy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic head and neck (H\&N) malignant lesions Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Radiotherapy, Palliative Care
- What is being tested?
- standard treatment and short course treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteItaly
- Study dates
- 8 Nov 2017to 8 Nov 2023
- 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
- symptomatic H\&N malignant lesions (primary solid tumors or metastases from solid tumor)
- age>18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
- no changes in supportive care in the week before radiotherapy
Who cannot join
- pregnancy
- previous irradiation of the same region
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
Bologna, BO, 40138
Alessio G Morganti, MD, 0512143564 ext. +39, alessio.morganti2@unibo.it
About this study
Official title: SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Head and Neck Cancer: an Interventional, Randomized, Multicentric Study
Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic head and neck (H\&N) malignant lesions
Read the detailed description
Standard treatment for H\&N lesions (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (2000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme
- Conditions
- Head and Neck Cancer, Radiotherapy, Palliative Care
- Being tested
- standard treatment, short course treatment
- Keywords
- Short Course Radiotherapy, Symptomatic head and neck lesions
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard treatmentRadiation
3000 cGy in 10 daily fractions
short course treatmentRadiation
2000 cGy in 4 fractions administered twice a day
| Study group | Role | What they receive |
|---|---|---|
| standard treatment | Active comparator | patients in this group are treated with 3000 cGy in 10 daily fraction Receives: Radiation: standard treatment |
| short course treatment | Experimental | patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval) Receives: Radiation: short course treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of palliation using the short course scheme compared with the standard scheme
reduction of initial symptoms (pain, bleeding, dysphagia, hoarseness, stridor, dehydration, malnutrition) after radiotherapy, evaluated as none-mild-moderate-severe before and after treatment
Measured: 3 months
Secondary outcomes (3)
acute toxicity in the two treatment groups
incidence of treatment-related acute adverse events in the two arms of the study registered using Radiation Therapy Oncology Group (RTOG) Cooperative Group Common Toxicity Criteria
Measured: 3 months
late toxicity in the two treatment groups
incidence of treatment-related adverse events in the two arms of the study registered using RTOG/European Organisation for Research and Treatment of Cancer(EORTC) Late Radiation Morbility Scoring Schema
Measured: 12 months
Quality of Life (QoL) assessment in the two groups
changes in QoL after treatment assessed using a specific EORTC questionnaire developed to assess the quality of life of palliative cancer care patients (C15-PAL)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start8 Nov 2017
- Primary completion8 Nov 2022 (estimated)
- Study completion8 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
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 Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804073
- Sponsor's protocol ID
- RT 15-05 SHARON HEAD AND NECK
- Status last verified
- Jan 2019
- First submitted
- 11 Jan 2019
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Head and Neck Cancer: an Interventional, Randomized, Multicentric Study
- ClinicalTrials.gov ID
- NCT03804073
- Acronym / sponsor ID
- RT 15-05 SHARON HEAD AND NECK
- Conditions
- Head and Neck Cancer, Radiotherapy, Palliative Care
- Keywords
- Short Course Radiotherapy, Symptomatic head and neck lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 8 Nov 2022 (estimated)
- Study completion
- 8 Nov 2023 (estimated)
- First posted
- 15 Jan 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.
Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic head and neck (H\&N) malignant lesions
Detailed description
Standard treatment for H\&N lesions (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (2000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard treatment | Active comparator | Radiation: standard treatmentpatients in this group are treated with 3000 cGy in 10 daily fraction |
| short course treatment | Experimental | Radiation: short course treatmentpatients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- symptomatic H\&N malignant lesions (primary solid tumors or metastases from solid tumor)
- age>18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
- no changes in supportive care in the week before radiotherapy
Key exclusion criteria (2 listed)
- pregnancy
- previous irradiation of 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 |
|---|---|---|
| standard treatment3000 cGy in 10 daily fractions | Radiation | standard treatment |
| short course treatment2000 cGy in 4 fractions administered twice a day | Radiation | short course treatment |
Primary outcome
Efficacy of palliation using the short course scheme compared with the standard scheme
Time frame: 3 months
reduction of initial symptoms (pain, bleeding, dysphagia, hoarseness, stridor, dehydration, malnutrition) after radiotherapy, evaluated as none-mild-moderate-severe before and after treatment
3 secondary outcomes
acute toxicity in the two treatment groups
Time frame: 3 months
late toxicity in the two treatment groups
Time frame: 12 months
Quality of Life (QoL) assessment in the two groups
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Individual participant dataSharing planned: No
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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 Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard treatment and short course treatment in people with Head and Neck Cancer and Radiotherapy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 2 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: status not confirmed, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessio G Morganti, MD (0512143564 ext. +39, alessio.morganti2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of palliation using the short course scheme compared with the standard scheme (time frame: 3 months). 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 Jan 2019.