Stereotactic Ablative Radiotherapy in Locally Advanced Non Small Cell Lung Cancer (START-NEW-ERA)

March 22, 2022 updated by: Fabio Arcidiacono, MD, Radiotherapy Oncology Centre "Santa Maria" Hospital

STereotactic Ablative RadioTherapy in NEWly Diagnosed and Recurrent Locally Advanced Non-small Cell Lung Canter Patients Unfit for concurrEnt RAdio-chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 patients, particularly the elderly, are unfit for concurrent ChT-RT because of their poor performance status and co-morbidities. Sequential ChT-RT and/or exclusive RT are options available for patients not suitable for concomitant approaches.

Median progression-free survival among patients receiving concurrent ChT-RT is poor and no more than 15% of cases are alive at 5 years.

This study is evaluating SABR in unresectable LA-NSCLC. Hypofractionated regimens of RT have emerged as a possible approach in LA-NSCLC, not only because prolonged treatments may discourage a proportion of elderly patients (20-30%) who are forced to give up treatment due to distance from the Radiotherapy Centre, but also for radiobiological reasons.

Recent technological advances in RT, first of all stereotactic body radiotherapy (SBRT), have made hypofractionation widely applicable with the possibility to administer few (5 to 8) fractions of high external beam doses to the tumor, sparing the surrounding healthy tissues by a rapid fall of dose outside the target.

LA-NSCLC patients will be discussed at the multidisciplinary lung cancer group and will be judged unfit for surgery and concurrent ChT-RT (e.g. elderly patients and/or large volume of disease and/or cardiovascular comorbidities) but suitable for RT. Neoadjuvant ChT will be evaluated case by case and will be prescribed only in fit patients.

Starting from the standard radical conventionally administered dose for LA-NSCLC (equivalent to at least 54-60 Gy in 27-30 fractions), the investigators decided to prescribe an ablative dose of at least 35-40 Gy in 5 fractions.

The SABR dose will be increased, case by case, respecting the maximum tolerance dose of healthy structures.

The purpose of this study is to explore SABR in the treatment of unresectable LA-NSCLC.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • TR
      • Terni, TR, Italy, 05100
        • Radiotherapy Oncology Centre "S.Maria" Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SABR in unresectable LA-NSCLC
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

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local control
Time Frame: 1 year, 2 years and 3 years
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
Time Frame: 6 months and 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thoracic nodal-recurrence free survival
Time Frame: 1 year, 2 years and 3 years
The interval between treatment and radiological evidence of any nodal recurrence outside the treated nodes and anyway outside the original isodose of 80%
1 year, 2 years and 3 years
Distant progression free-survival
Time Frame: 1 year, 2 years and 3 years
The interval between treatment and radiological evidence of systemic disease progression
1 year, 2 years and 3 years
Overall Survival
Time Frame: 1 year, 2 years, 3 years and 5 years
The overall survival will be calculated from treatment to patient death or last follow-up
1 year, 2 years, 3 years and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiotherapy Oncology Centre "Santa Maria" Hospital

Collaborators

Paola Anselmo,MD
Michelina Casale,PhD
Ernesto Maranzano,MD
Fabio Trippa,MD

Investigators

  • Principal Investigator: 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
  • Study Director: Fabio Trippa, MD, Radiotherapy Oncology Centre "S.Maria" Hospital
  • Study Chair: Ernesto Maranzano, MD, Radiotherapy Oncology Centre "S.Maria" Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

March 7, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

March 23, 2022

Study Record Updates

Last Update Posted (Actual)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SABR-LA-NSCLC 810

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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