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Short Course Radiation Therapy in Palliative Treatment of Abdominal Cancer

NCT ID: NCT03775005

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-08

Study Completion Date

2023-11-08

Brief Summary

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

Detailed Description

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Standard treatment for abdomen lesions (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (1800 cGy in 4 fractions of 450 cGy twice a day) to demonstrate non-inferiority of this scheme

Conditions

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Abdomen Tumors Radiotherapy Palliative Care

Keywords

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Short Course Radiotherapy Symptomatic abdomen lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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standard treatment

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

Group Type ACTIVE_COMPARATOR

standard treatment

Intervention Type RADIATION

3000 cGy in 10 daily fractions

short course treatment

patients in this group are treated with 1800 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)

Group Type EXPERIMENTAL

short course treatment

Intervention Type RADIATION

1800 cGy in 4 fractions administered twice a day

Interventions

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standard treatment

3000 cGy in 10 daily fractions

Intervention Type RADIATION

short course treatment

1800 cGy in 4 fractions administered twice a day

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* symptomatic abdomen malignant lesions (primary solid tumor 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Alessio Giuseppe Morganti

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessio G Morganti, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Bologna, BO, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessio G Morganti, MD

Role: CONTACT

Phone: 0512143564

Email: [email protected]

Facility Contacts

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Alessio G Morganti, MD

Role: primary

Other Identifiers

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RT-15-01 SHARON ABDOMEN

Identifier Type: -

Identifier Source: org_study_id