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Prospecitve Observational Study on a Risk Adaptive Scheme for SBRT for Thoracic Nodes Metastases

I

Istituto Clinico Humanitas

Status

Completed

Conditions

Thoracic Nodes Metastases

Treatments

Procedure: Inoperable thoracic nodes metastases

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

Oligometastatic patients with inoperable thoracic nodes metastases from any primary, except for hematologic malignancies, will undergo a risk adaptive scheme of stereotactic body radiation therapy (SBRT).

Full description

The observational study is designed to evaluate safety and efficacy of a risk adaptive scheme of stereotactic body radiation therapy (SRT) in oligometastatic patients with thoracic nodes metastases, medically inoperable, using VMAT RapidArc approach. The potential advantage of this technique is the ability to deliver a more selective irradiation to tumour's target while reducing doses to normal tissue, optimizing the therapeutic window.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients aged >18 years with ECOG 0-2
  • Karnofsky index > 70% (ECOG >2)
  • Any primary, except for hematologic malignancies
  • DFI (Disease-free interval) from diagnosis > 6 months
  • Unresectable lesions or inoperable patients or patients who refused surgery
  • Less than 3 metastatic thoracic nodes
  • No extrathoracic disease or other metastatic sites stable or responding after chemotherapy, with less than 5 metastatic sites
  • No life threatening conditions
  • Chemotherapy completed at least 1 week before treatment
  • Chemotherapy started at least 1 week after treatment allowed
  • Systemic therapies other than chemotherapy allowed (i.e hormonal therapies and/or immunotherapy)
  • Written informed consent

Exclusion criteria

  • Previous RT in the same region
  • Pregnant women
  • Patients with inability to consent

Trial design

32 participants in 1 patient group

Inoperable thoracic nodes metastases
Description:
Oligometastatic patients with inoperable thoracic nodes metastases from any primary
Treatment:
Procedure: Inoperable thoracic nodes metastases

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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