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

NCT03431415 | Withdrawn DMC

• 1 other identifier: RAXSIA
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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).

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Overall Survival

  5 years

• Level of morbidity

  5 years

• Level of efficacy in the SBRT arm

  5 years

• QOL assessment

  5 years

• FEV1 and DLCO decline at 1-year post-treatment in both arms

  1 year

Study Arms (2)

Surgery

ACTIVE COMPARATOR

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

Procedure: Anatomical Segmentectomy, Lobectomy or Bilobectomy

SBRT (Stereotactic Body Radiation Therapy)

ACTIVE COMPARATOR

Patients that will undergo SBRT as primary lung cancer treatment

Radiation: Stereotactic Body Radiation Therapy

Interventions

Anatomical Segmentectomy, Lobectomy or Bilobectomy PROCEDURE

Lung Cancer Anatomical Resection

Surgery

Stereotactic Body Radiation Therapy RADIATION

SBRT treatment. 48Gy in 4 sessions for peripheral lesions and 50Gy in 5 sessions for central lesions.

SBRT (Stereotactic Body Radiation Therapy)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec: lead
• CHU de Quebec-Universite Laval: collaborator

Study Sites (2)

Hôtel-Dieu de Québec (CHUQ)

Québec, Quebec, G1R2J6, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval

Québec, Quebec, G1V4G5, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Paula A Ugalde Figueroa, MD

  Associate Professor, Thoracic Surgeon, Research Coordinator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator (Thoracic Surgery)

Study Record Dates

• First Submitted: January 28, 2018
• First Posted: February 13, 2018
• Study Start: January 28, 2018
• Primary Completion: March 1, 2020
• Study Completion: February 1, 2025
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

CA (2)