Recurrent Non-small Cell Lung CancerNCT02250378
Stereotactic Radiosurgery Followed by Wedge Resection in Treating Patients With Early Stage Peripheral Non-small Cell Lung Cancer
A study testing stereotactic radiosurgery, therapeutic conventional surgery and laboratory biomarker analysis in people with Recurrent Non-small Cell Lung Cancer and Stage IA Non-small Cell Lung Cancer, run by University of Southern California at 1 site in United States.
Trial summary
This pilot clinical trial studies the side effects and how well stereotactic radiosurgery followed by wedge resection works in treating patients with early stage non-small cell lung cancer that is located in the outer, or peripheral, areas of the lung. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Non-small Cell Lung Cancer, Stage IA Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer
- What is being tested?
- stereotactic radiosurgery, therapeutic conventional surgery and laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Sep 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Biopsy proven non-small cell lung cancer
- Maximum tumor dimension =< 5 cm
- No clinical evidence of N1, N2 or N3 lymph nodes as assessed by CT and/or PET-CT
- No evidence of distant metastatic disease
- Tumor verified by a thoracic surgeon to be in a location that will permit a sublobar resection
Show all 26Show fewer
- Tumor located peripherally within the lung (peripheral defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions) and not touching the mediastinal pleura
- Pulmonary function tests (PFTs) with diffusing capacity of the lung for carbon monoxide (DLCO) within 90 days prior to registration
- Patient at high-risk of complications from lobectomy meeting a minimum of one major criteria or two minor criteria as described below:
- Major criteria
- Predicted postoperative forced expiratory volume in one second (FEV1) =< 40%
- Predicted postoperative DLCO =< 40%
- Age >= 72
- Minor criteria
- Predicted postoperative FEV1 41-60%
- Predicted postoperative DLCO 41-60%
- Pulmonary hypertension (defined by a pulmonary artery systolic pressure greater than 40 mm Hg) as estimated by echocardiography or right heart catheterization
- Poor left ventricular function (defined as an ejection fraction 40% or less)
- Resting or exercising arterial partial pressure of oxygen (pO2) =< 55 mmHg or oxygen saturation (SpO2) =< 88%
- Partial pressure of carbon monoxide (pCO2) > 45 mm Hg
- Modified Medical Research Council Dyspnea Scale >= 3
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- Ability to understand and the willingness to sign a written informed consent
Who cannot join
- Pregnant women
- Patients with central tumors within the proximal tree or touching the mediastinal pleura
- Patients with evidence of distant metastatic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Feasibility Study of Stereotactic Body Radiation Therapy Followed by Wedge Resection for Peripherally Located Early Stage Non-small Cell Lung Cancer
This pilot clinical trial studies the side effects and how well stereotactic radiosurgery followed by wedge resection works in treating patients with early stage non-small cell lung cancer that is located in the outer, or peripheral, areas of the lung. Stereotactic radiosurgery, also known as stereotactic body radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Wedge resection is a less invasive type of surgery for removal of the tumor and a small amount of normal tissue around it. Giving stereotactic radiosurgery followed by wedge resection may be a safe treatment option for patients who cannot receive standard treatment with lobectomy.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the safety and feasibility of a wedge resection following stereotactic body radiation therapy (SBRT) for early stage peripheral non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
- To assess pathologic response rates to SBRT as determined by pathologic examination of resected tumors.
II. To prospectively assess patient quality of life when treated with SBRT and wedge resection.
TERTIARY OBJECTIVES:
- To describe the location of viable tumor and to correlate pathologic response rates with radiation dose, size of tumor, and tumor histology.
II. To correlate pathologic response rates and functional imaging with pre- and post-treatment dual-input perfusion (DP)-computed tomography (CT) and positron emission tomography (PET)-CT.
III. To correlate changes in serum levels of deoxyribonucleic acid (DNA) methylation and circulating tumor cells (CTC) with pathologic response rates.
OUTLINE:
Patients undergo stereotactic radiosurgery every other day for 3 or 5 fractions (depending on the size tumor and proximity to the chest wall). Within 4-6 weeks after completion of stereotactic radiosurgery, patients undergo wedge resection.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months.
- Conditions
- Recurrent Non-small Cell Lung Cancer, Stage IA Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer
- Being tested
- stereotactic radiosurgery, therapeutic conventional surgery, laboratory biomarker analysis, quality-of-life assessment
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic radiosurgeryRadiation
Undergo stereotactic radiosurgery
therapeutic conventional surgeryProcedure or surgery
Undergo wedge resection
laboratory biomarker analysisOther
Correlative studies
quality-of-life assessmentOther
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (stereotactic radiosurgery, wedge resection) | Experimental | Patients undergo stereotactic radiosurgery every other day for 3 or 5 fractions (depending on the size tumor and proximity to the chest wall). Within 4-6 weeks after completion of stereotactic radiosurgery, patients undergo wedge resection. Receives: Radiation: stereotactic radiosurgery; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis; Other: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of grade 3-5 adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Treatment related toxicities will be assessed and recorded for each patient receiving treatment.
Measured: Up to 12 months after surgery
Rates of perioperative complications including blood loss, days in the intensive care unit, and operative time
Measured: Up to 12 months after surgery
Feasibility, determined by the number of patients who are able to complete wedge resection as well as receive the full dose of stereotactic radiosurgery
Measured: Up to 12 months after surgery
Secondary outcomes (2)
Pathologic response rates
The pathologic response rates will be determined by measuring the percent of viable cells in the resected specimen. Associations (e.g. between pathologic response rates and DP-CT, fludeoxyglucose [FDG] uptake, DNA methylation, and CTC levels) will be displayed visually with scatterplots or contingency tables and appropriate measure of association (Wilcoxon test, Fisher's exact test, Spearman correlation coefficient, and McNemar's test).
Measured: Up to 12 months after surgery
Quality of life assessment
Quality of life assessments will be summarized over time with descriptive statistics.
Measured: Up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionSep 2015
Why it stopped: No accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Eugene Chung, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250378
- Sponsor's protocol ID
- 2N-14-3
- Other IDs
- NCI-2014-01916, 2N-14-3, P30CA014089
- Status last verified
- Sep 2015
- First submitted
- 23 Sep 2014
- Last updated
- 16 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Stereotactic Body Radiation Therapy Followed by Wedge Resection for Peripherally Located Early Stage Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02250378
- Acronym / sponsor ID
- 2N-14-3
- Conditions
- Recurrent Non-small Cell Lung Cancer, Stage IA Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 26 Sep 2014 (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 pilot clinical trial studies the side effects and how well stereotactic radiosurgery followed by wedge resection works in treating patients with early stage non-small cell lung cancer that is located in the outer, or peripheral, areas of the lung. Stereotactic radiosurgery, also known as stereotactic body radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Wedge resection is a less invasive type of surgery for removal of the tumor and a small amount of normal tissue around it. Giving stereotactic radiosurgery followed by wedge resection may be a safe treatment option for patients who cannot receive standard treatment with lobectomy.
Detailed description
PRIMARY OBJECTIVES:
- To assess the safety and feasibility of a wedge resection following stereotactic body radiation therapy (SBRT) for early stage peripheral non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
- To assess pathologic response rates to SBRT as determined by pathologic examination of resected tumors.
II. To prospectively assess patient quality of life when treated with SBRT and wedge resection.
TERTIARY OBJECTIVES:
- To describe the location of viable tumor and to correlate pathologic response rates with radiation dose, size of tumor, and tumor histology.
II. To correlate pathologic response rates and functional imaging with pre- and post-treatment dual-input perfusion (DP)-computed tomography (CT) and positron emission tomography (PET)-CT.
III. To correlate changes in serum levels of deoxyribonucleic acid (DNA) methylation and circulating tumor cells (CTC) with pathologic response rates.
OUTLINE:
Patients undergo stereotactic radiosurgery every other day for 3 or 5 fractions (depending on the size tumor and proximity to the chest wall). Within 4-6 weeks after completion of stereotactic radiosurgery, patients undergo wedge resection.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (stereotactic radiosurgery, wedge resection) | Experimental | Radiation: stereotactic radiosurgery, Procedure: therapeutic conventional surgery, Other: laboratory biomarker analysis, Other: quality-of-life assessmentPatients undergo stereotactic radiosurgery every other day for 3 or 5 fractions (depending on the size tumor and proximity to the chest wall). Within 4-6 weeks after completion of stereotactic radiosurgery, patients undergo wedge resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Biopsy proven non-small cell lung cancer
- Maximum tumor dimension =< 5 cm
- No clinical evidence of N1, N2 or N3 lymph nodes as assessed by CT and/or PET-CT
- No evidence of distant metastatic disease
Key exclusion criteria (3 listed)
- Pregnant women
- Patients with central tumors within the proximal tree or touching the mediastinal pleura
- Patients with evidence of distant metastatic disease
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 radiosurgeryUndergo stereotactic radiosurgery | Radiation | Treatment (stereotactic radiosurgery, wedge resection) |
| therapeutic conventional surgeryUndergo wedge resection | Procedure or surgery | Treatment (stereotactic radiosurgery, wedge resection) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (stereotactic radiosurgery, wedge resection) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Other | Treatment (stereotactic radiosurgery, wedge resection) |
Primary outcome
Rate of grade 3-5 adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Time frame: Up to 12 months after surgery
Treatment related toxicities will be assessed and recorded for each patient receiving treatment.
Rates of perioperative complications including blood loss, days in the intensive care unit, and operative time
Time frame: Up to 12 months after surgery
Feasibility, determined by the number of patients who are able to complete wedge resection as well as receive the full dose of stereotactic radiosurgery
Time frame: Up to 12 months after surgery
2 secondary outcomes
Pathologic response rates
Time frame: Up to 12 months after surgery
Quality of life assessment
Time frame: Up to 12 months after surgery
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 16 Sep 2015.
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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.
Eugene Chung principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stereotactic radiosurgery, therapeutic conventional surgery and laboratory biomarker analysis in people with Recurrent Non-small Cell Lung Cancer and Stage IA Non-small Cell Lung Cancer, run by University of Southern California 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 26 inclusion and 3 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 16 Sep 2015. 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.
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?
Rate of grade 3-5 adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (time frame: Up to 12 months after surgery). The study lists 3 primary outcomes in all. 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 16 Sep 2015.