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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03431415
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : February 19, 2018
Sponsor:
Collaborator:
CHU de Quebec-Universite Laval
Information provided by (Responsible Party):
Paula Antonia Ugalde Figueroa, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

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).

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Stage I Surgery Stereotactic Body Radiation Therapy Procedure: Anatomical Segmentectomy, Lobectomy or Bilobectomy Radiation: Stereotactic Body Radiation Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgery Versus Stereotactic Body Radiation Therapy for Stage up to IA2 (T1a or T1b) Non-small Cell Lung Cancer
Actual Study Start Date : January 28, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 5 years ]
    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 :
  1. Overall Survival [ Time Frame: 5 years ]
    Overall survival rate at 5 years in both arms

  2. Level of morbidity [ Time Frame: 5 years ]
    Level of morbidity in both arms (CTCAE 4.0 - common toxicity criteria)

  3. Level of efficacy in the SBRT arm [ Time Frame: 5 years ]
    Level of efficacy in the SBRT arm (RECIST 1.1)

  4. QOL assessment [ Time Frame: 5 years ]
    QOL assessment with SF36 questionnaire (pre and post treatment) in both arms

  5. FEV1 and DLCO decline at 1-year post-treatment in both arms [ Time Frame: 1 year ]
    FEV1 or DLCO decline at 1-year post-treatment in both arms

  6. Health economic evaluation in both arms [ Time Frame: 5 years ]
    Health economic evaluation in both arms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431415


Contacts
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Contact: Paula A Ugalde Figueroa, MD 418-656-8711 ext 5503 paula.ugalde@criucpq.ulaval.ca
Contact: Arthur Vieira, MD 418-656-8711 ext 5524 arthur.vieira@criucpq.ulaval.ca

Locations
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Canada, Quebec
Hôtel-Dieu de Québec (CHUQ) Recruiting
Québec, Quebec, Canada, G1R2J6
Contact: Anne Dagnault, MD    +1(418)525-4444    anne.dagnault@mail.chudequebec.ca   
Principal Investigator: Anne Dagnault, MD         
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval Recruiting
Québec, Quebec, Canada, G1V4G5
Contact: Paula Ugalde, MD    4186568711 ext 5511    paula.ugalde@criucpq.ulaval.ca   
Contact: Arthur Vieira, MD    4186568711 ext 5524    arthur.vieira@criucpq.ulaval.ca   
Sub-Investigator: Arthur Vieira, MD         
Sub-Investigator: Catherine Labbé, MD         
Sub-Investigator: Yves Lacasse, MD         
Sub-Investigator: Annie Roy, Inf         
Sub-Investigator: Reda Haouari, Inf         
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
CHU de Quebec-Universite Laval
Investigators
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Principal Investigator: Paula A Ugalde Figueroa, MD Associate Professor, Thoracic Surgeon, Research Coordinator
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Responsible Party: Paula Antonia Ugalde Figueroa, Research Coordinator (Thoracic Surgery), Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
ClinicalTrials.gov Identifier: NCT03431415    
Other Study ID Numbers: RAXSIA
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

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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
Keywords provided by Paula Antonia Ugalde Figueroa, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec:
Lung
Cancer
Early-Stage
Video-assisted Thoracic Surgery
VATS
SBRT
Stereotactic Body Radiation Therapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms