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Stereotactic Ablative Radiotherapy in Locally Advanced Non Small Cell Lung Cancer

NCT05291780 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-03-23

No results posted yet for this study

Summary

This is a prospective, non-randomized, single arm, single institution phase II trial to evaluate the safety and effectiveness of stereoractic ablative radiotherapy (SABR) in selected unresectable newly diagnosed and recurrent locally advanced (LA) non-small cell lung cancer (NSCLC) patients unfit for concurrent chemo-radiotherapy (ChT-RT).

Patients unfit for concurrent ChT-RT but fit for chemotherapy will be enrolled to sequential ChT-SABR; patients unfit for ChT will be enrolled to exclusive SABR.

Conditions

  • Locally Advanced Lung Non-Small Cell Carcinoma

Interventions

RADIATION

Stereotactic Ablative Radiotherapy in Unresectable Locally Advanced Non-Small Cell Lung Cancer

The prescribed dose of stereotactic ablative radiotherapy (SABR) will be of at least 35-40 Gy in 5 fractions. The dose of SABR will be increased, case by case, respecting the maximum tolerance dose of the healthy structures. Participants will SABR once a day for 5 days, Monday through Friday (around 1 week).

Sponsors & Collaborators

  • Paola Anselmo,MD

    collaborator UNKNOWN

  • Michelina Casale,PhD

    collaborator UNKNOWN

  • Ernesto Maranzano,MD

    collaborator UNKNOWN

  • Fabio Trippa,MD

    collaborator UNKNOWN

  • Radiotherapy Oncology Centre "Santa Maria" Hospital

    lead OTHER

Principal Investigators

  • Fabio Arcidiacono, MD · Radiotherapy Oncology Centre "S.Maria" Hospital

  • Paola Anselmo, MD · Radiotherapy Oncology Centre "S.Maria" Hospital

  • Michelina Casale, PhD · Radiotherapy Oncology Centre "S.Maria" Hospital

  • Fabio Trippa, MD · Radiotherapy Oncology Centre "S.Maria" Hospital

  • Ernesto Maranzano, MD · Radiotherapy Oncology Centre "S.Maria" Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05291780 on ClinicalTrials.gov