Status:
COMPLETED
Stereotactic Ablative Radiotherapy in Locally Advanced Non Small Cell Lung Cancer
Lead Sponsor:
Radiotherapy Oncology Centre "Santa Maria" Hospital
Collaborating Sponsors:
Paola Anselmo,MD
Michelina Casale,PhD
Conditions:
Locally Advanced Lung Non-Small Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 newl...
Detailed Description
Current standard of care for fit patients with unresectable LA-NSCLC is concurrent chemo-radiotherapy (ChT-RT) which consists of 6 weeks of radiation and chemotherapy. Unfortunately many LA NSCLC pati...
Eligibility Criteria
Inclusion
- age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Histologically or cytologically confirmed non-small cell lung cancer
- LA-NSCLC at the first diagnosis or recurrent LA-NSCLC after previous surgery
- Stage II-III disease as determined by PET/CT and TC/MRI Brain (American Joint Committee on Cancer 7th or 8th Edition)
- oligo-metastatic LA-NSCLC with metastasis suitable to local treatment in the primary and metastatic site
- Participant is not eligible for surgical resection as determined by the multidisciplinary lung cancer group
- Participant is not eligible for concurrent chemotherapy as determined by the multidisciplinary lung cancer group
- Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
Exclusion
- LA-NSCLC patients eligible for surgical resection
- ECOG performance status 3 or more
- Inability to safely treat target lesions
- Pregnant women are excluded from this study because radiation therapy has known potential for teratogenic or abortifacient effects.
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05291780
Start Date
December 1 2015
End Date
December 1 2021
Last Update
March 23 2022
Active Locations (1)
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1
Radiotherapy Oncology Centre "S.Maria" Hospital
Terni, TR, Italy, 05100