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Stereotactic Ablative Radiotherapy in Synchronous and Metachronous Oligo-Metastatic Non Small Cell Lung Cancer

NCT06207292 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-01-16

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 stereotactic ablative radiotherapy (SABR) in oncogene addicted and non-oncogene addicted synchronous and/or metachronous oligo-metastatic (oligoM) non-small cell lung cancer (NSCLC) patients.

Conditions

  • NSCLC
  • NSCLC Stage IV
  • Oligometastatic Disease
  • Non Small Cell Lung Cancer
  • Non Small Cell Lung Cancer Metastatic
  • EGF-R Positive Non-Small Cell Lung Cancer
  • NSCLC Stage IV Without EGFR/ALK Mutation
  • Non-Small Cell Adenocarcinoma
  • Non-Small Cell Squamous Lung Cancer
  • Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor
  • Synchronous Metastases
  • Metachronous Metastasis

Interventions

RADIATION

Stereotactic Ablative Radiotherapy

The prescribed dose of stereotactic ablative radiotherapy (SABR) will be chosen based on the target to be treated and its proximity to organs at risk(s): Lung-peripheral 33-45 Gy/ 3 fractions Lung-central/ultra-central 35-60 Gy/5 fractions Mediastinal/supraclavicular node 35-45 Gy/5 fractions Liver 45-54 Gy/3 fractions; 50-65 Gy/5 fractions Bone non-spine 30-36 Gy/3 fractions; 35-50 Gy/5 fractions Bone spine 30-33 Gy/3 fractions (SIB); 35-40 Gy/ 5 fractions (SIB) Abdominal-pelvic node 33-39 Gy/ 3 fractions; 35-50 Gy/5 fractions Adrenal gland 30-42 Gy/3 fractions; 35-50 Gy/5 fractions

Sponsors & Collaborators

  • Paola Anselmo,MD

    collaborator UNKNOWN

  • Michelina Casale,PhD

    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, Terni

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

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

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2024-01-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT06207292 on ClinicalTrials.gov