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出境医 / 临床实验 / 2D-radiotherapy in Palliation of Advanced Esophageal Cancer (SHARON-2D)
2D-radiotherapy in Palliation of Advanced Esophageal Cancer (SHARON-2D)
Study Description
Brief Summary:
The study wants to define the efficacy of a short course 2D-radiation therapy in patients with symptomatic advanced esophageal cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Palliative Care | Radiation: Short course radiotherapy | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 17 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Short-course Accelerated 2D-radiotherapy in Palliative Treatment of Advanced Esophageal Cancer |
| Actual Study Start Date : | January 1, 2009 |
| Actual Primary Completion Date : | January 1, 2019 |
| Actual Study Completion Date : | January 1, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Short course radiotherapy
The radiotherapy is delivered over 2 days with accelerated hypo-fractionation and 2D-technique.
|
Radiation: Short course radiotherapy
An accelerated hypo-fractionation 2D-radiotherapy is delivered for palliation in patients with advanced esophageal cancer.
|
Outcome Measures
Primary Outcome Measures :
- 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).
Secondary Outcome Measures :
- Incidence of Treatment-Emergent Adverse Events [Acute radiation toxicity] [ Time Frame: 1 year ]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).
- Assessment of the Performance Status [ Time Frame: 1 year ]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).
- Assessment of the Overall Survival [ Time Frame: 1 year ]Overall Survival is evaluated from the end of radiotherapy to the last date of follow-up. It is calculated in months.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- prior radiotherapy to the same region
Contacts and Locations
Sponsors and Collaborators
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Investigators
| Principal Investigator: | Alessio G. Morganti, MD | Radiation Oncology Center, DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 17, 2019 | ||||
| First Posted Date ICMJE | April 19, 2019 | ||||
| Last Update Posted Date | September 16, 2019 | ||||
| Actual Study Start Date ICMJE | January 1, 2009 | ||||
| Actual Primary Completion Date | January 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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).
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| Original Primary Outcome Measures ICMJE |
Pain relief [ 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).
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | 2D-radiotherapy in Palliation of Advanced Esophageal Cancer | ||||
| Official Title ICMJE | Short-course Accelerated 2D-radiotherapy in Palliative Treatment of Advanced Esophageal Cancer | ||||
| Brief Summary | 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 Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Palliative Care | ||||
| Intervention ICMJE | Radiation: Short course radiotherapy
An accelerated hypo-fractionation 2D-radiotherapy is delivered for palliation in patients with advanced esophageal cancer.
|
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| Study Arms ICMJE | Experimental: Short course radiotherapy
The radiotherapy is delivered over 2 days with accelerated hypo-fractionation and 2D-technique.
Intervention: Radiation: Short course radiotherapy
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
17 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | January 1, 2019 | ||||
| Actual Primary Completion Date | January 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03922152 | ||||
| Other Study ID Numbers ICMJE | SHARON ESOPHAGUS-2D | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Alessio Giuseppe Morganti, IRCCS Azienda Ospedaliero-Universitaria di Bologna | ||||
| Study Sponsor ICMJE | IRCCS Azienda Ospedaliero-Universitaria di Bologna | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | IRCCS Azienda Ospedaliero-Universitaria di Bologna | ||||
| Verification Date | September 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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