Clinical trial NCT05291780: Stereotactic Ablative Radiotherapy in Locally Advanced Non Small Cell Lung Cancer
Official title: STereotactic Ablative RadioTherapy in NEWly Diagnosed and Recurrent Locally Advanced Non-small Cell Lung Canter Patients Unfit for concurrEnt RAdio-chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Locally Advanced Lung Non-Small Cell Carcinoma
Keywords: LA-NSCLC; SABR
Lead sponsor: Radiotherapy Oncology Centre "Santa Maria" Hospital
Sponsor class: OTHER
Collaborators: name: Paola Anselmo,MD
name: Michelina Casale,PhD
name: Ernesto Maranzano,MD
name: Fabio Trippa,MD
First posted: 2022-03-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Local control
timeFrame: 1 year, 2 years and 3 years
measure: Proportion of Participants Experiencing Grade 3 or Higher Toxicities
timeFrame: 6 months and 1 year
Secondary outcomes:
measure: Thoracic nodal-recurrence free survival
timeFrame: 1 year, 2 years and 3 years
measure: Distant progression free-survival
timeFrame: 1 year, 2 years and 3 years
measure: Overall Survival
timeFrame: 1 year, 2 years, 3 years and 5 years
Other outcomes:
Locations:
city: Terni
country: Italy
facility: Radiotherapy Oncology Centre "S.Maria" Hospital
state: TR
Study officials:
affiliation: Radiotherapy Oncology Centre "S.Maria" Hospital
name: Fabio Arcidiacono, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiotherapy Oncology Centre "S.Maria" Hospital
name: Paola Anselmo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiotherapy Oncology Centre "S.Maria" Hospital
name: Michelina Casale, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiotherapy Oncology Centre "S.Maria" Hospital
name: Fabio Trippa, MD
role: STUDY_DIRECTOR
affiliation: Radiotherapy Oncology Centre "S.Maria" Hospital
name: Ernesto Maranzano, MD
role: STUDY_CHAIR
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