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

Primary Purpose

Non-small Cell Lung Cancer Stage I, Surgery, Stereotactic Body Radiation Therapy

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Anatomical Segmentectomy, Lobectomy or Bilobectomy
Stereotactic Body Radiation Therapy
Sponsored by
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer Stage I focused on measuring Lung, Cancer, Early-Stage, Video-assisted Thoracic Surgery, VATS, SBRT, Stereotactic Body Radiation Therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Surgery

SBRT (Stereotactic Body Radiation Therapy)

Arm Description

Patients that will undergo surgery (anatomical segmentectomy, lobectomy or bilobectomy) as primary lung cancer treatment

Patients that will undergo SBRT as primary lung cancer treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 28, 2018
Last Updated
August 17, 2021
Sponsor
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Collaborators
CHU de Quebec-Universite Laval
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1. Study Identification

Unique Protocol Identification Number
NCT03431415
Brief Title
Surgery Versus Stereotactic Body Radiation Therapy for Stage up to IA2 (T1a or T1b) Non-small Cell Lung Cancer
Acronym
RAXSIA
Official Title
Surgery Versus Stereotactic Body Radiation Therapy for Stage up to IA2 (T1a or T1b) Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Accrual issues
Study Start Date
January 28, 2018 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Collaborators
CHU de Quebec-Universite Laval

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
Patients that will undergo surgery (anatomical segmentectomy, lobectomy or bilobectomy) as primary lung cancer treatment
Arm Title
SBRT (Stereotactic Body Radiation Therapy)
Arm Type
Active Comparator
Arm Description
Patients that will undergo SBRT as primary lung cancer treatment
Intervention Type
Procedure
Intervention Name(s)
Anatomical Segmentectomy, Lobectomy or Bilobectomy
Intervention Description
Lung Cancer Anatomical Resection
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Intervention Description
SBRT treatment. 48Gy in 4 sessions for peripheral lesions and 50Gy in 5 sessions for central lesions.
Primary Outcome Measure Information:
Title
Disease free survival
Description
To compare the disease free survival of patients with Stage up to IA2 (T1aN0M0 or T1bN0M0) NSCLC managed either by SBRT or surgery.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival rate at 5 years in both arms
Time Frame
5 years
Title
Level of morbidity
Description
Level of morbidity in both arms (CTCAE 4.0 - common toxicity criteria)
Time Frame
5 years
Title
Level of efficacy in the SBRT arm
Description
Level of efficacy in the SBRT arm (RECIST 1.1)
Time Frame
5 years
Title
QOL assessment
Description
QOL assessment with SF36 questionnaire (pre and post treatment) in both arms
Time Frame
5 years
Title
FEV1 and DLCO decline at 1-year post-treatment in both arms
Description
FEV1 or DLCO decline at 1-year post-treatment in both arms
Time Frame
1 year
Title
Health economic evaluation in both arms
Description
Health economic evaluation in both arms
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula A Ugalde Figueroa, MD
Organizational Affiliation
Associate Professor, Thoracic Surgeon, Research Coordinator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôtel-Dieu de Québec (CHUQ)
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1R2J6
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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