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Completed

NCT Number: NCT03922152

2D-radiotherapy in Palliation of Advanced Esophageal Cancer

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

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Key information

Conditions

Palliative Care Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Short Course Radiotherapy

Radiation

An accelerated hypo-fractionation 2D-radiotherapy is delivered for palliation in patients with advanced esophageal cancer.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: SHARON-2D

Important dates

Study start
2009
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2019
Registry last updated
Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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