Non-small Cell Lung CancerPhase 2POSTILVNCT01753414
Radical Resection Vs. Ablative Stereotactic Radiotherapy in Patients With Operable Stage I NSCLC
A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT) and Surgery in people with Non-small Cell Lung Cancer, run by Radiation Therapy Oncology Group at 4 sites in China.
Trial summary
Rationale: Surgery remains the standard of care for stage 1 (T1-2a N0)non-small cell lung cancer. Stereotactic body radiation therapy is a newer radiation treatment that gives fewer but higher and possibly more effective doses of radiation than standard radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT) and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 4 sitesChina
- Study dates
- Dec 2012to Jan 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Pathologically (histologically or cytologically) proven diagnosis of Stage I NSCLC [American Joint Committee on Cancer (AJCC), 7th ed.], T1N0M0; note: T1N0 disease must be confirmed by FDG-PET/CT. (FDG = 18F-fluorodeoxyglucose; PET = positron emission tomography; CT = Computed Tomography)
- Biopsy confirmation of diagnosis is strongly recommended but not required. If the biopsy is attempted and non-diagnostic, if the patient refuses biopsy, or if the risk of biopsy is considered too high, patients may be enrolled if the mass is suspicious for NSCLC based on 2 or more of the following criteria:
- Positive smoking history;
- Absence of benign calcifications within suspicious nodule;
- Activity on PET greater than normal tissue;
- Evidence of growth compared to previous imaging;
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- Presence of spiculation.
- The following primary cancer types are eligible: squamous cell carcinoma; adenocarcinoma; large cell carcinoma/ large cell neuroendocrine carcinoma; non-small cell carcinoma not otherwise specified.
- Patients with hilar or mediastinal lymph nodes ≤ 1 cm and no abnormal hilar or mediastinal uptake on PET and CT will be considered N0. Mediastinal lymph node biopsy is required for patients with visible nodes: patients with > 1 cm hilar or mediastinal lymph nodes on CT or with nodes appearing as abnormal on PET (including suspicious but nondiagnostic uptake). Such patients will not be eligible unless directed biopsies of all abnormal lymph nodes are negative for cancer or these nodes demonstrate a lack of change during the prior 6 months and thus are considered to be non-malignant.
- The patient must be considered a reasonable candidate for surgical resection using a lobectomy or pneumonectomy of the primary tumor within 6 weeks prior to registration, according to the following criteria based on the American College of Chest Physicians guidelines [165]:
- A qualified thoracic surgeon should make the determination that there would be a high likelihood of negative surgical margins;
- Baseline forced expiratory volume in 1 second (FEV1) >60% predicted, postoperative predicted FEV1 >40% predicted;
- Diffusion capacity of the lung for carbon monoxide (DLCO) >60% predicted, postoperative predicted DLCO > 40 % predicted;
- No baseline hypoxemia and/or hypercapnia;
- If the estimated postoperative FEV1 or DLCO <40% predicted indicates an increased risk for perioperative complications, including death, from a standard lung cancer resection (lobectomy or greater removal of lung tissue), then cardiopulmonary exercise testing to measure maximal oxygen consumption (VO2max) must be >60%;
- No severe pulmonary hypertension;
- No severe cerebral, acute or chronic cardiac, or peripheral vascular disease;
- Pleural effusion, if present, must be deemed too small to tap under CT guidance and must not be evident on chest x-ray. Pleural effusion that appears on chest x-ray will be permitted only if there is no evidence of malignancy after invasive cytologic assessment.
- Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
- History/physical examination, including documentation of weight within 6 weeks prior to registration;
- Evaluation by an experienced thoracic surgeon within 6 weeks prior to registration;
- FDG-PET/CT scan for staging and RT plan within 4 weeks prior to registration;
- CT scan (preferably with intravenous contrast, unless medically contraindicated) within 4 weeks prior to registration to include the entirety of both lungs, the mediastinum, liver, and adrenal glands; primary tumor dimension will be measured on CT scan.
- Zubrod Performance Status 0-1 within 6 weeks prior to registration;
- Age ≥ 18;
- For women of childbearing potential, a serum or urine pregnancy test must be negative within 72 hours prior to registration;
- Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment if assigned to treatment with SBRT.
- Patients must provide study specific informed consent prior to study entry.
Who cannot join
- Direct evidence of regional or distant metastases after PET and surgical staging studies, or synchronous primary malignancy or prior invasive malignancy in the past 3 years, with the following exceptions:
- carcinoma in situ;
- early stage skin cancer that has been definitively treated;
- when an invasive malignancy has been treated definitively and the patient has remained disease free for ≥ 3 years;
- Primary tumors >3 cm;
- Prior systemic chemotherapy or thoracic surgery involving lobectomy or pneumonectomy;
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- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
- Pure bronchioloalveolar carcinoma subtype of non-small cell lung cancer;
- Active systemic, pulmonary, or pleural pericardial infection;
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Chinese Academy of Medical Science
Beijing, 10021
Shandong Cancer Hospital, Jinan
Shangdong, 250117
Shanghai Cancer Center/Fudan University
Shanghai, 200032
Zhejiang Cancer Hospital, Hangzhou
Zhejiang, 310022
About this study
Official title: POSTILV: A RANDOMIZED PHASE II TRIAL IN PATIENTS WITH OPERABLE STAGE I NON-SMALL CELL LUNG CANCER: RADICAL RESECTION VERSUS ABLATIVE STEREOTACTIC RADIOTHERAPY - This is a Limited Participation Study.
Rationale: Surgery remains the standard of care for stage 1 (T1-2a N0)non-small cell lung cancer. Stereotactic body radiation therapy is a newer radiation treatment that gives fewer but higher and possibly more effective doses of radiation than standard radiation. This technique may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known whether stereotactic body radiation therapy is more effective than surgery in treating non-small cell lung cancer.
Purpose: The primary aim of this randomized phase II trial is to determine if the efficacy of SBRT is comparable to that of standard surgical interventions for patients with T1N0 non-small cell lung cancer.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Stereotactic Body Radiation Therapy (SBRT), Surgery
- Keywords
- Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Daily fractions
SurgeryProcedure or surgery
Radical resection
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Other | R0 resection (radical resection) with nodal dissection or sampling (RODS). Receives: Procedure: Surgery |
| Stereotactic Body Radiation Therapy (SBRT) | Experimental | Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Alive Without Local-regional Failure at Two Years (Local-regional Tumor Control)
Local-regional failure (LRF) is defined differently for each arm. LRF after RODS is defined as recurrence, defined by CT, confirmed by PET/CT whenever possible, i.e., development of tumor masses at site of resection, hilum (N1 nodal region), mediastinum (N2-N3 nodes), ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of the staple line of RODS. LRF after SBRT is defined as tumor progression on CT per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, confirmed by positron PET/CT, within same lobe, hilum (N1 nodes), mediastinum (N2-N3 nodes), or ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of original planning target volume (PTV). Local-regional control time is defined as time from randomization to the date of first LRF, death, or last known follow-up (censored), whichever occurred first. Rates are estimated using the Kaplan-Meier method.
Measured: From date of randomization to two years
Secondary outcomes (11)
Overall Survival (Percentage of Participants Alive)
Overall survival rates are estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Two-year rates are provided.
Measured: From date of randomization to date of death or last follow-up. Maximum follow-up was 7.0 years.
Percentage of Participants With Local-regional Failure (LRF)
LRF rates are estimated using the cumulative incidence method. LRF is defined differently for each arm. LRF after RODS is defined as recurrence, defined by CT, confirmed by PET/CT whenever possible, i.e., development of tumor masses at site of resection, hilum (N1 nodal region), mediastinum (N2-N3 nodes), ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of the staple line of RODS. LRF after SBRT is defined as tumor progression on CT per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, confirmed by PET/CT, within same lobe, hilum (N1 nodes), mediastinum (N2-N3 nodes), or ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of original PTV. LRF time is defined as time from randomization to the date of first LRF, last known follow-up (censored), or death without LRF (competing risk), whichever occurred first. Two-year rates are provided.
Measured: From date of randomization to the date of first local-regional failure, death, or last known follow-up, whichever occurred first. Maximum follow-up is 7.0 years.
Percentage of Participants With Distant Failure
Distant failure rates are estimated using the cumulative incidence method. Distant failure is defined as appearance of tumor within another ipsilateral (non-primary) lobe ≥ 2 cm from the original planning target volume (PTV) or distant metastasis, including appearance of tumor deposits characteristic of NSCLC metastasis (chest wall other than incision sites, mediastinal structures/diaphragm, malignant pleural/pericardial effusion), contralateral lung and/or other distant sites. Time to distant failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Two-year rates are provided.
Measured: From date of randomization to date of first distant failure, death, or last known follow-up, whichever occurred first. Maximum follow-up was 7.0 years.
Percentage of Participants Alive Without Disease [Disease-free Survival (DFS)]
Failure rates are estimated using the Kaplan-Meier method, where failure is defined as LRF, DF, or death from any cause. LRF is defined differently for each arm. LRF after RODS is defined as recurrence, defined by CT, confirmed by PET/CT whenever possible, i.e., development of tumor masses at the resection site, hilum, mediastinum, or ipsilateral supraclavicular fossa for upper lobe tumors, or within 3 cm of the staple line of RODS. LRF after SBRT is defined as tumor progression on CT per RECIST criteria, confirmed by PET/CT, within same lobe, hilum, mediastinum, or ipsilateral supraclavicular fossa for upper lobe tumors, or within 3 cm of original PTV. DF is defined as tumor within a non-primary lobe ≥ 2 cm from the original planning target volume or distant metastasis. Failure time is defined as time from randomization to the date of first failure or last known follow-up (censored), whichever occurred first. Two-year rates are provided.
Measured: From date of randomization to the date of first failure, death, or last known follow-up, whichever occurred first. Maximum follow-up is 7.0 years.
Number of Participants by Failure Site
Local-regional failure (LRF) is defined differently for each arm. LRF after RODS is defined as recurrence, defined by CT, confirmed by PET/CT whenever possible, i.e., development of tumor masses at site of resection, hilum, mediastinum, ipsilateral supraclavicular fossa for upper lobe tumors, or within 3 cm of the staple line of RODS. LRF after SBRT is defined as tumor progression on CT per RECIST criteria, confirmed by PET/CT, within same lobe, hilum, mediastinum, or ipsilateral supraclavicular fossa for upper lobe tumors, or within 3 cm of original planning target volume (PTV). Distant failure is defined as tumor within a non-primary lobe ≥ 2 cm from the original planning target volume or distant metastasis, including tumor deposits characteristic NSCLC metastasis (chest wall other than incision sites, mediastinal structures/diaphragm, malignant pleural/pericardial effusion), contralateral lung and/or other distant sites.
Measured: From date of randomization to date of last known follow-up. Maximum follow-up was 7.0 years.
Best PET Tumor Response
PET Tumor Response of Irradiated Target Lesions is defined as
- Complete Metabolic Response (CMR): Tumor 18F-fluorodeoxyglucose (FDG)-activity decreased to less than mean background of the aortic arch blood pool.
- Partial Metabolic Response (PMR): At least a 30% decrease in the maximum of relative tumor FDG-activity of target lesions
- Progressive Metabolic Disease (PMD): At least a 20% increase in the maximum of relative tumor FDG-activity of target lesions
- Stable Metabolic Disease (SMD): Neither sufficient reduction to qualify for (major pathological response) PMR nor sufficient increase to qualify for PMD The percentage of decrease or increase was globally estimated based on readings of (tumor activity-aorta activity)/aorta activity.
Measured: From date of randomization to date of last known follow-up. Maximum follow-up was 7.0 years.
Number of Participants by Highest Grade Adverse Event Reported
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
Measured: From date of randomization to the date of last known follow-up. Maximum follow-up time was 7.0 years.
Number of Participants With Surgical and Radiation Treatment Credentialing Completed and Documented Before Enrollment (Trial Feasibility)
Measured: baseline
Number of Eligible Participants (Trial Feasibility)
Goal: 95% of participants retain eligibility status (meet all eligibility criteria) after central review by headquarters staff.
Measured: Baseline
Number of Participants With Baseline Forms Completed and Provided Within 30 Days of Randomization (Trial Feasibility)
Measured: Baseline
Number of Participants Lost to Follow-up (Trial Feasibility)
Goal: < 3% of participants lost to follow-up.
Measured: From date of randomization to date of last known follow-up. Maximum follow-up was 7.0 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startDec 2012
- Primary completion3 Apr 2023
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- Varian Medical Systems
- Responsible party
- Sponsor
- Investigators
- Feng-Ming (Spring) Kong, MD, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753414
- Sponsor's protocol ID
- RF-3502
- Acronym
- POSTILV
- Status last verified
- Apr 2024
- First submitted
- 17 Dec 2012
- Last updated
- 6 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Elbanna M, Shiue K, Edwards D, Cerra-Franco A, Agrawal N, Hinton J, Mereniuk T, Huang C, Ryan JL, Smith J, Aaron VD, Burney H, Zang Y, Holmes J, Langer M, Zellars R, Lautenschlaeger T. Impact of Lung Parenchymal-Only Failure on Overall Survival in Early-Stage Lung Cancer Patients Treated With Stereotactic Ablative Radiotherapy. Clin Lung Cancer. 2021 May;22(3):e342-e359. doi: 10.1016/j.cllc.2020.05.024. Epub 2020 Jun 2.
PubMed 32736936
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POSTILV: A RANDOMIZED PHASE II TRIAL IN PATIENTS WITH OPERABLE STAGE I NON-SMALL CELL LUNG CANCER: RADICAL RESECTION VERSUS ABLATIVE STEREOTACTIC RADIOTHERAPY - This is a Limited Participation Study.
- ClinicalTrials.gov ID
- NCT01753414
- Acronym / sponsor ID
- POSTILV / RF-3502
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- Varian Medical Systems
- Study start
- Dec 2012
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- Jan 2026 (estimated)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Posted 6 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Surgery remains the standard of care for stage 1 (T1-2a N0)non-small cell lung cancer. Stereotactic body radiation therapy is a newer radiation treatment that gives fewer but higher and possibly more effective doses of radiation than standard radiation. This technique may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known whether stereotactic body radiation therapy is more effective than surgery in treating non-small cell lung cancer.
Purpose: The primary aim of this randomized phase II trial is to determine if the efficacy of SBRT is comparable to that of standard surgical interventions for patients with T1N0 non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Other | Procedure: SurgeryR0 resection (radical resection) with nodal dissection or sampling (RODS). |
| Stereotactic Body Radiation Therapy (SBRT) | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT)Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Pathologically (histologically or cytologically) proven diagnosis of Stage I NSCLC [American Joint Committee on Cancer (AJCC), 7th ed.], T1N0M0; note: T1N0 disease must be confirmed by FDG-PET/CT. (FDG = 18F-fluorodeoxyglucose; PET = positron emission tomography; CT = Computed Tomography)
- Biopsy confirmation of diagnosis is strongly recommended but not required. If the biopsy is attempted and non-diagnostic, if the patient refuses biopsy, or if the risk of biopsy is considered too high, patients may be enrolled if the mass is suspicious for NSCLC based on 2 or more of the following criteria:
- Positive smoking history;
- Absence of benign calcifications within suspicious nodule;
- Activity on PET greater than normal tissue;
Key exclusion criteria (10 listed)
- Direct evidence of regional or distant metastases after PET and surgical staging studies, or synchronous primary malignancy or prior invasive malignancy in the past 3 years, with the following exceptions:
- Primary tumors >3 cm;
- Prior systemic chemotherapy or thoracic surgery involving lobectomy or pneumonectomy;
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
- Pure bronchioloalveolar carcinoma subtype of non-small cell lung cancer;
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 |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)Daily fractions | Radiation | Stereotactic Body Radiation Therapy (SBRT) |
| SurgeryRadical resection | Procedure or surgery | Surgery |
Primary outcome
Percentage of Participants Alive Without Local-regional Failure at Two Years (Local-regional Tumor Control)
Time frame: From date of randomization to two years
Local-regional failure (LRF) is defined differently for each arm. LRF after RODS is defined as recurrence, defined by CT, confirmed by PET/CT whenever possible, i.e., development of tumor masses at site of resection, hilum (N1 nodal region), mediastinum (N2-N3 nodes), ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of the staple line of RODS. LRF after SBRT is defined as tumor progression on CT per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, confirmed by positron PET/CT, within same lobe, hilum (N1 nodes), mediastinum (N2-N3 nodes), or ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of original planning target volume (PTV). Local-regional control time is defined as time from randomization to the date of first LRF, death, or last known follow-up (censored), whichever occurred first. Rates are estimated using the Kaplan-Meier method.
11 secondary outcomes
Overall Survival (Percentage of Participants Alive)
Time frame: From date of randomization to date of death or last follow-up. Maximum follow-up was 7.0 years.
Percentage of Participants With Local-regional Failure (LRF)
Time frame: From date of randomization to the date of first local-regional failure, death, or last known follow-up, whichever occurred first. Maximum follow-up is 7.0 years.
Percentage of Participants With Distant Failure
Time frame: From date of randomization to date of first distant failure, death, or last known follow-up, whichever occurred first. Maximum follow-up was 7.0 years.
Percentage of Participants Alive Without Disease [Disease-free Survival (DFS)]
Time frame: From date of randomization to the date of first failure, death, or last known follow-up, whichever occurred first. Maximum follow-up is 7.0 years.
Number of Participants by Failure Site
Time frame: From date of randomization to date of last known follow-up. Maximum follow-up was 7.0 years.
Best PET Tumor Response
Time frame: From date of randomization to date of last known follow-up. Maximum follow-up was 7.0 years.
Number of Participants by Highest Grade Adverse Event Reported
Time frame: From date of randomization to the date of last known follow-up. Maximum follow-up time was 7.0 years.
Number of Participants With Surgical and Radiation Treatment Credentialing Completed and Documented Before Enrollment (Trial Feasibility)
Time frame: baseline
Number of Eligible Participants (Trial Feasibility)
Time frame: Baseline
Number of Participants With Baseline Forms Completed and Provided Within 30 Days of Randomization (Trial Feasibility)
Time frame: Baseline
Number of Participants Lost to Follow-up (Trial Feasibility)
Time frame: From date of randomization to date of last known follow-up. Maximum follow-up was 7.0 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32736936Elbanna M, Shiue K, Edwards D, Cerra-Franco A, Agrawal N, Hinton J, Mereniuk T, Huang C, Ryan JL, Smith J, Aaron VD, Burney H, Zang Y, Holmes J, Langer M, Zellars R, Lautenschlaeger T. Impact of Lung Parenchymal-Only Failure on Overall Survival in Early-Stage Lung Cancer Patients Treated With Stereotactic Ablative Radiotherapy. Clin Lung Cancer. 2021 May;22(3):e342-e359. doi: 10.1016/j.cllc.2020.05.024. Epub 2020 Jun 2.
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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.
Feng-Ming (Spring) Kong, MD, PhD principal investigator
Case Western Reserve University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT) and Surgery in people with Non-small Cell Lung Cancer, run by Radiation Therapy Oncology Group at 4 sites in China.
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 28 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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?
Yes. Results are posted in the registry (first posted 6 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Alive Without Local-regional Failure at Two Years (Local-regional Tumor Control) (time frame: From date of randomization to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01753414, which also lists 1 linked publication.
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 6 Jan 2025.