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2D-radiotherapy in Palliation of Advanced Esophageal Cancer (SHARON-2D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03922152
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Alessio Giuseppe Morganti, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 :
  1. 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).

  2. 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).

  3. 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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922152


Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
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Principal Investigator: Alessio G. Morganti, MD Radiation Oncology Center, DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy

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Responsible Party: Alessio Giuseppe Morganti, Professor, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT03922152     History of Changes
Other Study ID Numbers: SHARON ESOPHAGUS-2D
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alessio Giuseppe Morganti, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
palliative care
radiotherapy
pain
quality of life
esophageal cancer
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases