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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03804203
Other study ID # RT 15-07 SHARON ESOPHAGUS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 8, 2017
Est. completion date November 8, 2023

Study information

Verified date January 2019
Source Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Contact Alessio G Morganti, MD
Phone 0512143564
Email alessio.morganti2@unibo.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic esophageal malignant lesions


Description:

Standard treatment for esophageal lesions (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (2000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme


Recruitment information / eligibility

Status Recruiting
Enrollment 98
Est. completion date November 8, 2023
Est. primary completion date November 8, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- symptomatic esophageal malignant lesions (primary solid tumors or metastases from solid tumor);

- age>18 years;

- ECOG performance status 0-3

- no changes in supportive care in the week before radiotherapy

Exclusion Criteria:

- pregnancy

- previous irradiation of the same region

Study Design


Intervention

Radiation:
standard treatment
3000 cGy in 10 daily fractions
short course treatment
2000 cGy in 4 fractions administered twice a day

Locations

Country Name City State
Italy Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital Bologna BO

Sponsors (1)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of palliation using the short course scheme compared with the standard scheme: Likert scale reduction of initial symptoms after radiotherapy, assessed with Likert scale (dysphagia, odynophagia, regurgitation, chest-back pain are evaluated as none-mild-moderate-severe) 3 months
Secondary acute toxicity in the two treatment groups incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria 3 months
Secondary late toxicity in the two treatment groups incidence of treatment-related adverse events in the two arms of the study registered using RTOG/EORTC Late Radiation Morbility Scoring Schema 12 months
Secondary Quality of Life (QoL): EORTC questionnaire C15-PAL changes in QoL after the treatment assessed using European Organization for Research and Treatment of Cancer (EORTC) questionnaire C15-PAL (a specific questionnaire from EORTC developed to assess the quality of life of palliative cancer care patients) 12 months
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