Stereotactic Ablative Radiotherapy in Locally Advanced Non Small Cell Lung Cancer

NCT05291780 | Completed

• 1 other identifier: SABR-LA-NSCLC 810
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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

Keywords

LA-NSCLC; SABR

Outcome Measures

Primary Outcomes (2)

• Local control

  A lack of progression (i.e., any response and stable disease) of the treated volume according to RECIST and PERCIST. Local recurrence (LR) was defined as tumor progression within the radiation field (95% of the recurrence volume within the original 80% isodose of SABR). Local recurrence-free survival (LR-FS) was defined as the interval between treatment and radiological evidence of LR.

  1 year, 2 years and 3 years

• Proportion of Participants Experiencing Grade 3 or Higher Toxicities

  SABR will be considered safe if no grade (G) 3 or higher toxicities appears. Toxicity, graded according to Common Terminology Criteria for Adverse Events (CTCAE v3.0) will be assessed during SABR and at all follow-up intervals. Toxicity will be recorded as acute when occurred during SABR or within 3 months after completion of treatment. When the time interval will be longer than 3 months, toxicity will be defined late.

  6 months and 1 year

Secondary Outcomes (3)

• Thoracic nodal-recurrence free survival

  1 year, 2 years and 3 years

• Distant progression free-survival

  1 year, 2 years and 3 years

• Overall Survival

  1 year, 2 years, 3 years and 5 years

Study Arms (1)

SABR in unresectable LA-NSCLC

EXPERIMENTAL

Patients fit for chemotherapy will be enrolled to sequential chemotherapy-stereotactic ablative radiotherapy (SABR), while patients unfit for chemotherapy will be enrolled to exclusive stereotactic ablative radiotherapy (SABR).

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

Interventions

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

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).

SABR in unresectable LA-NSCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radiotherapy Oncology Centre "Santa Maria" Hospital: lead
• Paola Anselmo,MD: collaborator
• Michelina Casale,PhD: collaborator
• Ernesto Maranzano,MD: collaborator
• Fabio Trippa,MD: collaborator

Study Sites (1)

Radiotherapy Oncology Centre "S.Maria" Hospital

Terni, TR, 05100, Italy

Location

Related Publications (23)

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Study Officials

• Fabio Arcidiacono, MD

  Radiotherapy Oncology Centre "S.Maria" Hospital

  PRINCIPAL INVESTIGATOR

• Paola Anselmo, MD

  Radiotherapy Oncology Centre "S.Maria" Hospital

  PRINCIPAL INVESTIGATOR

• Michelina Casale, PhD

  Radiotherapy Oncology Centre "S.Maria" Hospital

  PRINCIPAL INVESTIGATOR

• Fabio Trippa, MD

  Radiotherapy Oncology Centre "S.Maria" Hospital

  STUDY DIRECTOR

• Ernesto Maranzano, MD

  Radiotherapy Oncology Centre "S.Maria" Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 23, 2022
• Study Start: December 1, 2015
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)