2D-radiotherapy in Palliation of Advanced Esophageal Cancer

Palliative Care Clinical Trial

— SHARON-2D  

Official title:

Short-course Accelerated 2D-radiotherapy in Palliative Treatment of Advanced Esophageal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03922152
• Other study ID #: SHARON ESOPHAGUS-2D
• Status: Completed
• Phase: N/A
• Start date: January 1, 2009
• Est. completion date: January 1, 2019

Study information

• Verified date: September 2019
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study wants to define the efficacy of a short course 2D-radiation therapy in patients with symptomatic advanced esophageal cancer.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Palliative Care

Intervention

Radiation:
• Short course radiotherapy
An accelerated hypo-fractionation 2D-radiotherapy is delivered for palliation in patients with advanced esophageal cancer.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 year
Secondary	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).	1 year
Secondary	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).	1 year
Secondary	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.	1 year