Clinical trial NCT03431415: Surgery Versus Stereotactic Body Radiation Therapy for Stage up to IA2 (T1a or T1b) Non-small Cell Lung Cancer
Official title: Surgery Versus Stereotactic Body Radiation Therapy for Stage up to IA2 (T1a or T1b) Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Non-small Cell Lung Cancer Stage I
Surgery
Stereotactic Body Radiation Therapy
Keywords: Lung
Cancer
Early-Stage
Video-assisted Thoracic Surgery
VATS
SBRT
Stereotactic Body Radiation Therapy
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
Collaborators: name: CHU de Quebec-Universite Laval
First posted: 2018-02-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is disease free survival rate at 5 years in stage IA2 (T1aN0M0 or T1bN0M0 only) non-small cell lung cancer (NSCLC) patients treated either by surgery or stereotactic body radiation therapy (SBRT).

Detailed description: Today, the best medical literature available confirms that surgery is superior to radiation therapy in the treatment of the early stage lung cancer. However, good emerging data demonstrates potential equality between these two treatments. Two major international studies have tried to compare both treatments but have failed to complete the study because of the lack of patients accrual. We chose to design a trial in which patients will be part of a shared decision making process in selecting the treatment modality.

Patients with early stage lung cancer, that can undergo surgical treatment will be offered SBRT, and in conjunction with the pulmonologist will decide which treatment they prefer. We intend to complete the recruitment of patients within 02 years, then follow-up for 5 more years to collect data.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-75
* Pathologically (histologically or cytologically) proven NSCLC.
* Stage IA2 T1aN0M0 or T1bN0M0 only, fit for surgery.

  * Tumor ≤ 2 cm (T1a or T1b according to AJCC, 8th ed.)
* Hilar or mediastinal lymph nodes ≤ 1 cm with no abnormal hilar or mediastinal uptake on PET scan are considered N0.

  * Patients with hilar or mediastinal lymph nodes \> 1 cm on CT scan or abnormal PET scan (including suspicious but non-diagnostic uptake) are eligible, provided directed tissue biopsies by EBUS or mediastinoscopy of all abnormally identified areas are negative for cancer.
  * EBUS preferable
  * No regional or distant metastases.
* Resectable disease and treatable by SBRT
* Peripherally located tumor.

  * Primary tumor within or touching the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree are excluded (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi).
  * No involvement of the central pleura and/or structures of the mediastinum.
* Staging studies must be done within 8 weeks prior to study entry
* Patients must provide study specific informed consent prior to study entry.

Exclusion Criteria:

* Previously operated lung cancer.
* Previous thoracic irradiation.
* Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.
* Pulmonary nodule manifested as pure ground-glass opacity.
* Severe pulmonary hypertension.
* Severe cardiac, hepatic or renal insufficiency.
* Severe peripheral vascular disease.
* Severe cerebral or psychiatric pathologies.
* Severe chronic heart disease.
* Life expectancy \< 6 months.
* Pregnant or lactating woman.
* Unwilling to have follow-up.
* Central tumor where pneumonectomy might be considered.

Primary outcomes:
measure: Disease free survival
timeFrame: 5 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 5 years
measure: Level of morbidity
timeFrame: 5 years
measure: Level of efficacy in the SBRT arm
timeFrame: 5 years
measure: QOL assessment
timeFrame: 5 years
measure: FEV1 and DLCO decline at 1-year post-treatment in both arms
timeFrame: 1 year
measure: Health economic evaluation in both arms
timeFrame: 5 years
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Hôtel-Dieu de Québec (CHUQ)
state: Quebec
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
state: Quebec
Study officials:
affiliation: Associate Professor, Thoracic Surgeon, Research Coordinator
name: Paula A Ugalde Figueroa, MD
role: PRINCIPAL_INVESTIGATOR
References: