免费获得国外相关药品，最快 1 个工作日回馈药物信息

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
Layout table for study information
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 :
  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.


Eligibility Criteria
Layout table for eligibility information
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
Layout table for investigator information
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
 (submitted: September 12, 2019) 		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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019) 		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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • Acute radiation toxicity [ Time Frame: 1 year ]
    Acute toxicity after treatment is evaluated with the Common Terminology Criteria for Adverse Events (CTCAE). Values range from 1 (minimum acute toxicity) to 5 (maximum acute toxicity).
  • Late radiation toxicity [ Time Frame: 1 year ]
    Late toxicity after the treatment is evaluated with the Toxicity criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC). Values range from 1 (minimum late toxicity) to 5 (maximum/severe late toxicity).
  • Quality of life (QOL) [ Time Frame: 1 year ]
    Quality of life after the treatment is evaluated according with the Cancer Linear Analog Scale (CLAS). Values range from 0 (better status) to 10 (worst status).
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
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.
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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2019) 		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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Principal Investigator: Alessio G. Morganti, MD Radiation Oncology Center, DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy
PRS Account IRCCS Azienda Ospedaliero-Universitaria di Bologna
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

治疗案例

前沿医讯