Lung NeoplasmsPhase 2NCT01622621
Stereotactic Body Radiotherapy (SBRT) Versus Sublobar Resection for High-Risk Patients Non-Small Lung Cancer
A Phase 2 study testing Sublobar Resection and Stereotactic Body Radiotherapy (SBRT) in people with Lung Neoplasms, run by Mayo Clinic at 1 site in United States.
Trial summary
This randomized phase II trial is for medically inoperable early stage non-small cell lung cancer (NSCLC) patients. It is designed to compare the number of patients who are disease free and alive at 2 years between Stereotactic Body Radiotherapy (SBRT) and surgical intervention arms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Sublobar Resection and Stereotactic Body Radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to 25 Apr 2017
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a suspicious lung nodule for clinical stage I NSCLC.
- Pathologic confirmation at the time of surgery is acceptable. Patients randomized to SBRT require core biopsy for diagnosis prior to treatment.
- Patient must have a mass ≤ 5 cm maximum diameter by CT size estimate that is clinical stage I (T1N0, T2N0)
- Patient must have a CT scan of the chest and upper abdomen and PET-scan within 60 days prior to date of registration.
- Patient must have an Eastern Cooperative Oncology Group (ECOG) or Zubrod performance status 0, 1, or 2.
- Patient must meet at least one major criteria or meet a minimum of two minor criteria as described below:
Show all 18Show fewer
- Major Criteria:
- Forced expiratory volume in one second (FEV1) ≤ 50% predicted
- Carbon monoxide diffusing capacity (DLCO) ≤ 50% predicted
- Minor Criteria:
- Age ≥75
- FEV1 51-60% predicted
- DLCO 51-60% predicted
- Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mmHg) as estimated by echocardiography or right heart catheterization
- Poor left ventricular function (defined as an ejection fraction of 40% or less)
- Resting or Exercise Arterial oxygen partial pressure (pO2) ≤ 55 mm Hg or blood oxygen saturation (SpO2) ≤ 88%
- pCO2 > 45 mm Hg
- Modified Medical Research Council (MMRC) Dyspnea Scale ≥ 3.
Who cannot join
- Patient must not have had previous intra-thoracic radiation therapy.
- No prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, localized prostate cancer, stage 0 Chronic lymphocytic leukemia (CLL), or other cancer disease-free > 3 yrs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Randomized Phase II Trial of Stereotactic Body Radiotherapy (SBRT) Versus Sublobar Resection for High-Risk Patients With Early Stage Non-Small Lung Cancer (NSCLC)
This randomized phase II trial is for medically inoperable early stage non-small cell lung cancer (NSCLC) patients. It is designed to compare the number of patients who are disease free and alive at 2 years between Stereotactic Body Radiotherapy (SBRT) and surgical intervention arms. SBRT is less invasive and felt to be equally effective to surgery for early stage NSCLC. Surgery is currently the standard of care for these patients. The hypothesis of this study is that SBRT is at least as good as surgery for disease free survival at 2 years.
Read the detailed description
The current standard of care for Stage I Non-Small Lung Cancer (NSCLC) is sublobar surgical resection. Recent trials have suggested that early stage NSCLC might be successfully treated with SBRT amongst those who are medically inoperable. SBRT is the precise delivery of a high dose of radiation to control tumors while limiting damage to surrounding normal tissues. Patients on the SBRT arm will receive 54 Grays (Gy) in 3 fractions. One gray is the absorption of one joule of energy, in the form of ionizing radiation, per kilogram of matter. Recent advances with three-dimensional conformal and Intensity Modulated Radiotherapy (IMRT) techniques can now compensate for lung motion and allow delivery of high-dose, single fractions to the primary lung tumor for patients with clinical state I NSCLC.
Local control and survival results appear promising. SBRT for early stage lung cancer may offer a potentially equivalent, non-invasive treatment alternative to surgical resection. Additionally, SBRT may be associated with fewer complications and better quality of life. SBRT may be an acceptable or even preferred treatment option in higher-risk patients not able to tolerate a surgical lobectomy. This clinical dilemma is increasingly faced in our lung cancer practice at Mayo Clinic, with no comparative effectiveness data to guide treatment decisions.
Patients will be evaluated by both Thoracic Surgery and Radiation Oncology. Randomization can occur through either group but a patient must see both in consultation prior to randomization. For patients meeting enrollment criteria but unwilling to participate in randomization, observational arms for each of SBRT and sublobar resection will enroll up to 24 patients as part of the 96 patient total.
The patients will receive the following tests as part of their clinical care:
- Computed Tomography (CT)-Positron Emission Tomography (PET) will be used for mediastinal imaging
- Endobronchial/endoscopic ultrasound (EBUS/EUS)-Fine Needle Aspiration (FNA) or mediastinoscopy will be used for pathologic assessment of level 2 lymph nodes (N2) greater than 1 cm in the short axis on CT scan and/or SUV greater than 1.5 fold background
- Follow-up CT scans at 6 months, 12 months, 18 months, and 24 months for the Surgery and SBRT groups.
- Follow-up Pulmonary Function Tests at 1 year
- Conditions
- Lung Neoplasms
- Being tested
- Sublobar Resection, Stereotactic Body Radiotherapy (SBRT)
- Keywords
- Lung, Cancer
- Medical subject headings
- Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublobar ResectionProcedure or surgery
Undergo surgery which removes a sublobar resection of the lung
Stereotactic Body Radiotherapy (SBRT)Radiation
54 Gy in 3 fractions
| Study group | Role | What they receive |
|---|---|---|
| Randomized Sublobar Resection | Active comparator | Randomized by computer to receive a sublobar resection. Receives: Procedure: Sublobar Resection |
| Randomized SBRT | Active comparator | Randomized by computer to receive Stereotactic Body Radiotherapy (SBRT). Receives: Radiation: Stereotactic Body Radiotherapy (SBRT) |
| Observation Sublobar Resection | Active comparator | Patient decides with doctor to undergo a sublobar resection. Receives: Procedure: Sublobar Resection |
| Observation SBRT | Active comparator | Patient decides with doctor to undergo SBRT. Receives: Radiation: Stereotactic Body Radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients alive at 2 years (Overall Survival [OS])
All patients who are alive at 2 years.
Measured: 2 years after treatment
Secondary outcomes (1)
Number of patients with disease free survival (DFS) at 2 years
All patients who are alive and free of disease at 2 years. Disease burden will be determined by computed tomography.
Measured: 2 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startMay 2012
- Primary completion25 Apr 2017
- Study completion25 Apr 2017
Why it stopped: Unable to enroll to the randomized arm.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Wigle, Mayo Clinic
- Investigators
- Dennis Wigle, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622621
- Sponsor's protocol ID
- 11-000805
- Status last verified
- Sep 2020
- First submitted
- 15 Jun 2012
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Stereotactic Body Radiotherapy (SBRT) Versus Sublobar Resection for High-Risk Patients With Early Stage Non-Small Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT01622621
- Acronym / sponsor ID
- 11-000805
- Conditions
- Lung Neoplasms
- Keywords
- Lung, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll to the randomized arm.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- 25 Apr 2017 (actual)
- Study completion
- 25 Apr 2017 (actual)
- First posted
- 19 Jun 2012 (estimated)
- 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.
This randomized phase II trial is for medically inoperable early stage non-small cell lung cancer (NSCLC) patients. It is designed to compare the number of patients who are disease free and alive at 2 years between Stereotactic Body Radiotherapy (SBRT) and surgical intervention arms. SBRT is less invasive and felt to be equally effective to surgery for early stage NSCLC. Surgery is currently the standard of care for these patients. The hypothesis of this study is that SBRT is at least as good as surgery for disease free survival at 2 years.
Detailed description
The current standard of care for Stage I Non-Small Lung Cancer (NSCLC) is sublobar surgical resection. Recent trials have suggested that early stage NSCLC might be successfully treated with SBRT amongst those who are medically inoperable. SBRT is the precise delivery of a high dose of radiation to control tumors while limiting damage to surrounding normal tissues. Patients on the SBRT arm will receive 54 Grays (Gy) in 3 fractions. One gray is the absorption of one joule of energy, in the form of ionizing radiation, per kilogram of matter. Recent advances with three-dimensional conformal and Intensity Modulated Radiotherapy (IMRT) techniques can now compensate for lung motion and allow delivery of high-dose, single fractions to the primary lung tumor for patients with clinical state I NSCLC.
Local control and survival results appear promising. SBRT for early stage lung cancer may offer a potentially equivalent, non-invasive treatment alternative to surgical resection. Additionally, SBRT may be associated with fewer complications and better quality of life. SBRT may be an acceptable or even preferred treatment option in higher-risk patients not able to tolerate a surgical lobectomy. This clinical dilemma is increasingly faced in our lung cancer practice at Mayo Clinic, with no comparative effectiveness data to guide treatment decisions.
Patients will be evaluated by both Thoracic Surgery and Radiation Oncology. Randomization can occur through either group but a patient must see both in consultation prior to randomization. For patients meeting enrollment criteria but unwilling to participate in randomization, observational arms for each of SBRT and sublobar resection will enroll up to 24 patients as part of the 96 patient total.
The patients will receive the following tests as part of their clinical care:
- Computed Tomography (CT)-Positron Emission Tomography (PET) will be used for mediastinal imaging
- Endobronchial/endoscopic ultrasound (EBUS/EUS)-Fine Needle Aspiration (FNA) or mediastinoscopy will be used for pathologic assessment of level 2 lymph nodes (N2) greater than 1 cm in the short axis on CT scan and/or SUV greater than 1.5 fold background
- Follow-up CT scans at 6 months, 12 months, 18 months, and 24 months for the Surgery and SBRT groups.
- Follow-up Pulmonary Function Tests at 1 year
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Randomized Sublobar Resection | Active comparator | Procedure: Sublobar ResectionRandomized by computer to receive a sublobar resection. |
| Randomized SBRT | Active comparator | Radiation: Stereotactic Body Radiotherapy (SBRT)Randomized by computer to receive Stereotactic Body Radiotherapy (SBRT). |
| Observation Sublobar Resection | Active comparator | Procedure: Sublobar ResectionPatient decides with doctor to undergo a sublobar resection. |
| Observation SBRT | Active comparator | Radiation: Stereotactic Body Radiotherapy (SBRT)Patient decides with doctor to undergo SBRT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients must have a suspicious lung nodule for clinical stage I NSCLC.
- Pathologic confirmation at the time of surgery is acceptable. Patients randomized to SBRT require core biopsy for diagnosis prior to treatment.
- Patient must have a mass ≤ 5 cm maximum diameter by CT size estimate that is clinical stage I (T1N0, T2N0)
- Patient must have a CT scan of the chest and upper abdomen and PET-scan within 60 days prior to date of registration.
- Patient must have an Eastern Cooperative Oncology Group (ECOG) or Zubrod performance status 0, 1, or 2.
Key exclusion criteria (2 listed)
- Patient must not have had previous intra-thoracic radiation therapy.
- No prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, localized prostate cancer, stage 0 Chronic lymphocytic leukemia (CLL), or other cancer disease-free > 3 yrs.
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 |
|---|---|---|
| Sublobar ResectionUndergo surgery which removes a sublobar resection of the lung | Procedure or surgery | Observation Sublobar Resection, Randomized Sublobar Resection |
| Stereotactic Body Radiotherapy (SBRT)54 Gy in 3 fractions | Radiation | Observation SBRT, Randomized SBRT |
Primary outcome
Number of patients alive at 2 years (Overall Survival [OS])
Time frame: 2 years after treatment
All patients who are alive at 2 years.
1 secondary outcome
Number of patients with disease free survival (DFS) at 2 years
Time frame: 2 years after treatment
Results and safety
The study was stopped early (reason given: Unable to enroll to the randomized arm.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
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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.
Dennis Wigle, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sublobar Resection and Stereotactic Body Radiotherapy (SBRT) in people with Lung Neoplasms, run by Mayo Clinic at 1 site in United States.
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 18 inclusion and 2 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: stopped early, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to enroll to the randomized arm.). Results are not available in the source record.
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?
Number of patients alive at 2 years (Overall Survival [OS]) (time frame: 2 years after treatment). 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 11 Sep 2020.