Short Course Radiation Therapy in Palliative Treatment of Thoracic Cancer

S

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status

Enrolling

Conditions

Radiotherapy
Thoracic Cancer
Palliative Care

Treatments

Radiation: short course treatment
Radiation: standard treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03804307
RT 15-03 SHARON THORAX

Details and patient eligibility

About

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

Full description

Standard treatment for thoracic 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

Enrollment

72 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • symptomatic thoracic malignant lesions (primary solid tumors or metastases from solid tumor)
  • age> 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
  • no changes in supportive care in the week before radiotherapy

Exclusion criteria

  • pregnancy
  • previous irradiation of the same region

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

standard treatment
Active Comparator group
Description:
patients in this group are treated with 3000 cGy in 10 daily fraction
Treatment:
Radiation: standard treatment
short course treatment
Experimental group
Description:
patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)
Treatment:
Radiation: short course treatment

Trial contacts and locations

1

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Central trial contact

Alessio G Morganti, MD

Data sourced from clinicaltrials.gov

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