Surgery Versus Stereotactic Body Radiation Therapy for Stage up to IA2 (T1a or T1b) Non-small Cell Lung Cancer (RAXSIA)

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).

Study Overview

• Status: Withdrawn
• Conditions: Surgery; Non-small Cell Lung Cancer Stage I; Stereotactic Body Radiation Therapy
• Intervention / Treatment: Procedure: Anatomical Segmentectomy, Lobectomy or Bilobectomy; Radiation: Stereotactic Body Radiation Therapy

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1R2J6
      • Hôtel-Dieu de Québec (CHUQ)
    • Québec, Quebec, Canada, G1V4G5
      • Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgery; Patients that will undergo surgery (anatomical segmentectomy, lobectomy or bilobectomy) as primary lung cancer treatment	Procedure: Anatomical Segmentectomy, Lobectomy or Bilobectomy; Lung Cancer Anatomical Resection
Active Comparator: SBRT (Stereotactic Body Radiation Therapy); Patients that will undergo SBRT as primary lung cancer treatment	Radiation: Stereotactic Body Radiation Therapy; SBRT treatment. 48Gy in 4 sessions for peripheral lesions and 50Gy in 5 sessions for central lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival	To compare the disease free survival of patients with Stage up to IA2 (T1aN0M0 or T1bN0M0) NSCLC managed either by SBRT or surgery.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall survival rate at 5 years in both arms	5 years
Level of morbidity	Level of morbidity in both arms (CTCAE 4.0 - common toxicity criteria)	5 years
Level of efficacy in the SBRT arm	Level of efficacy in the SBRT arm (RECIST 1.1)	5 years
QOL assessment	QOL assessment with SF36 questionnaire (pre and post treatment) in both arms	5 years
FEV1 and DLCO decline at 1-year post-treatment in both arms	FEV1 or DLCO decline at 1-year post-treatment in both arms	1 year
Health economic evaluation in both arms	Health economic evaluation in both arms	5 years

Collaborators and Investigators

• Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
• Collaborators: CHU de Quebec-Universite Laval
• Investigators: Principal Investigator: Paula A Ugalde Figueroa, MD, Associate Professor, Thoracic Surgeon, Research Coordinator

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2018
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: January 28, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Cancer; Lung; SBRT; VATS; Stereotactic Body Radiation Therapy; Early-Stage; Video-assisted Thoracic Surgery
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: RAXSIA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No