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Short Course Radiation Therapy in Palliative Treatment of Esophageal Cancer

Primary Purpose

Esophageal Cancer, Radiotherapy, Palliative Care

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

standard treatment

short course treatment

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Short Course Radiotherapy, Symptomatic esophageal lesions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard treatment

short course treatment

Arm Description

patients in this group are treated with 3000 cGy in 10 daily fraction

patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

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

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)

Full Information

NCT ID

NCT03804203

First Posted

January 11, 2019

Last Updated

January 14, 2019

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

1. Study Identification

Unique Protocol Identification Number

NCT03804203

Brief Title

Short Course Radiation Therapy in Palliative Treatment of Esophageal Cancer

Official Title

SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Esophageal Cancer: an Interventional, Randomized, Multicentric Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Recruiting

Study Start Date

November 8, 2017 (Actual)

Primary Completion Date

November 8, 2022 (Anticipated)

Study Completion Date

November 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer, Radiotherapy, Palliative Care

Keywords

Short Course Radiotherapy, Symptomatic esophageal lesions

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

standard treatment

Arm Type

Active Comparator

Arm Description

patients in this group are treated with 3000 cGy in 10 daily fraction

Arm Title

short course treatment

Arm Type

Experimental

Arm Description

patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)

Intervention Type

Radiation

Intervention Name(s)

standard treatment

Intervention Description

3000 cGy in 10 daily fractions

Intervention Type

Radiation

Intervention Name(s)

short course treatment

Intervention Description

2000 cGy in 4 fractions administered twice a day

Primary Outcome Measure Information:

Title

Efficacy of palliation using the short course scheme compared with the standard scheme: Likert scale

Description

reduction of initial symptoms after radiotherapy, assessed with Likert scale (dysphagia, odynophagia, regurgitation, chest-back pain are evaluated as none-mild-moderate-severe)

Time Frame

3 months

Secondary Outcome Measure Information:

Title

acute toxicity in the two treatment groups

Description

incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria

Time Frame

3 months

Title

late toxicity in the two treatment groups

Description

incidence of treatment-related adverse events in the two arms of the study registered using RTOG/EORTC Late Radiation Morbility Scoring Schema

Time Frame

12 months

Title

Quality of Life (QoL): EORTC questionnaire C15-PAL

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alessio G Morganti, MD

Phone

0512143564

Ext

+39

alessio.morganti2@unibo.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alessio G Morganti, MD

Organizational Affiliation

Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital

City

Bologna

State/Province

ZIP/Postal Code

40138

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alessio G Morganti, MD

Phone

0512143564

Ext

+39

alessio.morganti2@unibo.it

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Short Course Radiation Therapy in Palliative Treatment of Esophageal Cancer

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