2D-radiotherapy in Palliation of Advanced Esophageal Cancer

Not Applicable

Completed

• Conditions: Palliative Care
• Interventions: Radiation: Short course radiotherapy

• Registration Number: NCT03922152
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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 Timeline

• Study Start: 2009-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-19
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-12
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Short course radiotherapy	Short course radiotherapy	The radiotherapy is delivered over 2 days with accelerated hypo-fractionation and 2D-technique.

Primary Outcome Measures

Name	Time	Method
Assessment of symptoms [odynophagia, chest-back pain, dysphagia, regurgitation]	1 year	Symptoms were graded using the IAEA scoring system. Values range from 0 (no symptom) to 4 (severe symptom).

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Acute radiation toxicity]	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	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	1 year	Overall Survival is evaluated from the end of radiotherapy to the last date of follow-up. It is calculated in months.