Palliative CareSHARON-2DNCT03922152
2D-radiotherapy in Palliation of Advanced Esophageal 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 efficacy of a short course 2D-radiation therapy in patients with symptomatic advanced esophageal 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
- 17 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 esophageal 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: Short-course Accelerated 2D-radiotherapy in Palliative Treatment of Advanced Esophageal Cancer
The study wants to define the efficacy of a short course 2D-radiation therapy in patients with symptomatic advanced esophageal cancer.
Read the detailed description
The study wants to define the efficacy of a short course accelerated 2D-radiation therapy delivered in twice daily fractions and 2 consecutive days for symptomatic palliation of advanced esophageal cancer.
- Conditions
- Palliative Care
- Being tested
- Short course radiotherapy
- Keywords
- palliative care, radiotherapy, pain, quality of life, esophageal cancer
- Medical subject headings
- Pain, Esophageal Neoplasms
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 esophageal cancer.
| Study group | Role | What they receive |
|---|---|---|
| Short course radiotherapy | Experimental | The radiotherapy is delivered over 2 days with accelerated hypo-fractionation and 2D-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 [odynophagia, chest-back pain, dysphagia, regurgitation]
Symptoms were graded using the IAEA scoring system. Values range from 0 (no symptom) to 4 (severe symptom).
Measured: 1 year
Secondary outcomes (3)
Incidence of Treatment-Emergent Adverse Events [Acute radiation toxicity]
Acute toxicity after treatment is evaluated with the Radiation Therapy Oncology Group (RTOG) scale. Values range from 0 (no acute toxicity) to 4 (maximum acute toxicity).
Measured: 1 year
Assessment of the Performance Status
Performance Status after the treatment is evaluated according with the Eastern Cooperative Oncology Group (ECOG) score. Values range from 0 (better status) to 5 (worst status).
Measured: 1 year
Assessment of the Overall Survival
Overall Survival is evaluated from the end of radiotherapy to the last date of follow-up. It is calculated in months.
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 posted19 Apr 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
- 17 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, DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922152
- Sponsor's protocol ID
- SHARON ESOPHAGUS-2D
- Acronym
- SHARON-2D
- Status last verified
- Sep 2019
- First submitted
- 17 Apr 2019
- Last updated
- 16 Sep 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 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-course Accelerated 2D-radiotherapy in Palliative Treatment of Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT03922152
- Acronym / sponsor ID
- SHARON-2D / SHARON ESOPHAGUS-2D
- Conditions
- Palliative Care
- Keywords
- palliative care, radiotherapy, pain, quality of life, esophageal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 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
- 19 Apr 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 efficacy of a short course 2D-radiation therapy in patients with symptomatic advanced esophageal cancer.
Detailed description
The study wants to define the efficacy of a short course accelerated 2D-radiation therapy delivered in twice daily fractions and 2 consecutive days for symptomatic palliation of advanced esophageal 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 and 2D-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 esophageal 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 esophageal cancer. | Radiation | Short course radiotherapy |
Primary outcome
Assessment of symptoms [odynophagia, chest-back pain, dysphagia, regurgitation]
Time frame: 1 year
Symptoms were graded using the IAEA scoring system. Values range from 0 (no symptom) to 4 (severe symptom).
3 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Acute radiation toxicity]
Time frame: 1 year
Assessment of the Performance Status
Time frame: 1 year
Assessment of the Overall Survival
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 16 Sep 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, 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 16 Sep 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 [odynophagia, chest-back pain, dysphagia, regurgitation] (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 16 Sep 2019.