Non-small Cell Lung Cancer Stage IRAXSIANCT03431415
Surgery Versus Stereotactic Body Radiation Therapy for Stage up to IA2 (T1a or T1b) Non-small Cell Lung Cancer
A study testing Anatomical Segmentectomy, Lobectomy or Bilobectomy and Stereotactic Body Radiation Therapy in people with Non-small Cell Lung Cancer Stage I and Surgery, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 2 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer Stage I, Surgery, Stereotactic Body Radiation Therapy
- What is being tested?
- Anatomical Segmentectomy, Lobectomy or Bilobectomy and Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- 28 Jan 2018to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hôtel-Dieu de Québec (CHUQ)
Québec, Quebec, G1R2J6
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
Québec, Quebec, G1V4G5
About this study
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).
Read the 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.
- Being tested
- Anatomical Segmentectomy, Lobectomy or Bilobectomy, Stereotactic Body Radiation Therapy
- Keywords
- Lung, Cancer, Early-Stage, Video-assisted Thoracic Surgery, VATS, SBRT, Stereotactic Body Radiation Therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomical Segmentectomy, Lobectomy or BilobectomyProcedure or surgery
Lung Cancer Anatomical Resection
Stereotactic Body Radiation TherapyRadiation
SBRT treatment. 48Gy in 4 sessions for peripheral lesions and 50Gy in 5 sessions for central lesions.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Active comparator | Patients that will undergo surgery (anatomical segmentectomy, lobectomy or bilobectomy) as primary lung cancer treatment Receives: Procedure: Anatomical Segmentectomy, Lobectomy or Bilobectomy |
| SBRT (Stereotactic Body Radiation Therapy) | Active comparator | Patients that will undergo SBRT as primary lung cancer treatment Receives: Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (6)
Overall Survival
Overall survival rate at 5 years in both arms
Measured: 5 years
Level of morbidity
Level of morbidity in both arms (CTCAE 4.0 - common toxicity criteria)
Measured: 5 years
Level of efficacy in the SBRT arm
Level of efficacy in the SBRT arm (RECIST 1.1)
Measured: 5 years
QOL assessment
QOL assessment with SF36 questionnaire (pre and post treatment) in both arms
Measured: 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
Measured: 1 year
Health economic evaluation in both arms
Health economic evaluation in both arms
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start28 Jan 2018
- Primary completionMar 2020 (estimated)
- Study completionFeb 2025 (estimated)
Why it stopped: Accrual issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer Stage IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de Quebec-Universite Laval
- Responsible party
- Principal investigator, Paula Antonia Ugalde Figueroa, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Investigators
- Paula A Ugalde Figueroa, MD, Principal investigator, Associate Professor, Thoracic Surgeon, Research Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431415
- Sponsor's protocol ID
- RAXSIA
- Acronym
- RAXSIA
- Status last verified
- Aug 2021
- First submitted
- 28 Jan 2018
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery Versus Stereotactic Body Radiation Therapy for Stage up to IA2 (T1a or T1b) Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03431415
- Acronym / sponsor ID
- RAXSIA / RAXSIA
- Keywords
- Lung, Cancer, Early-Stage, Video-assisted Thoracic Surgery, VATS, SBRT, Stereotactic Body Radiation Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Accrual issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecUniversity, hospital or other
- Collaborators
- CHU de Quebec-Universite Laval
- Study start
- 28 Jan 2018 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Active comparator | Procedure: Anatomical Segmentectomy, Lobectomy or BilobectomyPatients that will undergo surgery (anatomical segmentectomy, lobectomy or bilobectomy) as primary lung cancer treatment |
| SBRT (Stereotactic Body Radiation Therapy) | Active comparator | Radiation: Stereotactic Body Radiation TherapyPatients that will undergo SBRT as primary lung cancer treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients aged 18-75
- Pathologically (histologically or cytologically) proven NSCLC.
- Stage IA2 T1aN0M0 or T1bN0M0 only, fit for surgery.
- Hilar or mediastinal lymph nodes ≤ 1 cm with no abnormal hilar or mediastinal uptake on PET scan are considered N0.
- Resectable disease and treatable by SBRT
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatomical Segmentectomy, Lobectomy or BilobectomyLung Cancer Anatomical Resection | Procedure or surgery | Surgery |
| Stereotactic Body Radiation TherapySBRT treatment. 48Gy in 4 sessions for peripheral lesions and 50Gy in 5 sessions for central lesions. | Radiation | SBRT (Stereotactic Body Radiation Therapy) |
Primary outcome
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.
6 secondary outcomes
Overall Survival
Time frame: 5 years
Level of morbidity
Time frame: 5 years
Level of efficacy in the SBRT arm
Time frame: 5 years
QOL assessment
Time frame: 5 years
FEV1 and DLCO decline at 1-year post-treatment in both arms
Time frame: 1 year
Health economic evaluation in both arms
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
Related trials for Non-small Cell Lung Cancer Stage I
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
RecruitingPhase 3
Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial
Lung Non-Small Cell Carcinoma
RecruitingPhase 2
Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer
Early Stage Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Not yet recruitingObservational study
Treatment Pattern and Patient Outcomes Among Stage I-II Unresected NSCLC Patients
Non-small Cell Lung Cancer, NSCLC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula A Ugalde Figueroa, MD principal investigator
Associate Professor, Thoracic Surgeon, Research Coordinator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomical Segmentectomy, Lobectomy or Bilobectomy and Stereotactic Body Radiation Therapy in people with Non-small Cell Lung Cancer Stage I and Surgery, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.