- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01185639
Stereotactic Body Radiation Therapy (SBRT) in Metastatic Non-small Cell Lung Cancer
November 11, 2019 updated by: Wake Forest University Health Sciences
Phase II Study of Stereotactic Body Radiation Therapy (SBRT) After First-Line Chemotherapy for Metastatic NSCLC
This protocol is a single arm phase II multi-center trial evaluating the efficacy of Stereotactic Body Radiation Therapy (SBRT) in patients with oligometastatic non-small cell lung cancer (NSCLC) with response or stable disease after 4 cycles of first-line chemotherapy.
The core hypothesis tested is that SBRT after 4 cycles of first-line chemotherapy is feasible, safe, provides durable local control of treated lesions and improves time to progression compared to historical controls.
Patients are eligible for enrollment if they have metastatic NSCLC with ≤5 lesions amenable to SBRT.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
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Wilmington, North Carolina, United States, 28401
- Coastal Carolina Radiation Oncology
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
General
- Patients with AJCC sixth edition metastatic non-small cell lung carcinoma
- Pathologic diagnosis of stage 4 non-small cell lung cancer prior to enrollment.
- Patients must have response or stable disease by RECIST criteria after 4 cycles of first-line chemotherapy
- Maximum of number of lesions per patient will be 5 total. .
- Patients with solitary brain metastases previously treated with surgery or stereotactic radiosurgery (+/- WBRT) and currently controlled at the time of study enrollment are also eligible. Patients with history of brain metastases must have an MRI showing no active brain metastases within 80 days of study enrollment. Patients with a history of brain metastases may have up to 5 extracranial sites of disease except for those with an untreated primary tumor where section 3.1.3.3 will also apply.
- Patients with newly diagnosed stage IV NSCLC with an untreated primary must no more than 3 active extracranial metastatic lesions other than the primary site and regional lymph nodes.
- Age ≥ 18 years old
- Performance Status 0-2 (ECOG)
- A signed study specific consent form is required.
Lung (only applies to patients with active lung lesions)
- Patients cannot have more than 3 lung lesions
- Local failure after surgical resection will be consider a metastatic lesion for purposes of protocol inclusion.
- All lung lesions must be visible on CT imaging
- Cumulative diameter of lung lesions must be <7cm
- Patients may have active mediastinal disease in a single mediastinal nodal station if he/she has not received prior mediastinal RT
- Must meet criteria regarding status of primary tumor site described in section 3.1.9.
- Must be able to anticipate achieving SBRT dosimetry guidelines
- Must have adequate lung function defined within 90 days of enrollment as: (1) Forced Expiratory Volume in 1 second (FEV1) >30% of predicted or >800 Ml, (2) diffusing capacity of the lung for carbon monoxide (DLCO) >30 % predicted and (3) no evidence of actively worsening respiratory status
Liver (only applies to patients with active liver lesions
- Patients cannot have more than 3 liver lesions
- All active liver lesions must be discrete on CT or MRI imaging
- Combined diameter of all liver lesions must be <6cm
- Must be able to anticipate achieving SBRT plan per dosimetry guidelines for the liver.
- Liver function tests (AST, ALT, total bilirubin) should be within ≤ 3 times the upper limit of normal (ULN)
- Serum Albumin must be >2.5g/dL
- Patients cannot have active ascites.
Adrenal Gland
- Unilateral adrenal disease
- Must be able to anticipate achieving the SBRT plan per dosimetry guidelines.
Bone Lesions
- Treatment of any bone lesion is permissible if it is anticipated that the dosimetry guidelines can be met.
Spine and Paraspinal lesions
- Patients cannot have more than 3 vertebrae or paraspinal sites involved (each involved vertebral body or paraspinal site is scored as 1 site of disease)
- Must be no clinical or radiographic evidence of spinal cord compression
- If spinal metastases is within previously irradiated field, there must be a 6 month interval between prior radiation course and study enrollment
- Prior spinal cord maximum dose at level of vertebral disease must be ≤50Gy
Exclusion Criteria:
- Primary tumor progression on first-line chemotherapy
- Patients with complete response to first-line chemotherapy with no measurable target for SBRT
- >5 metastatic lesions or >3 metastatic lesions in patients with an untreated primary site are ineligible (ipsilateral hilar and mediastinal lymph nodes are considered part of an untreated primary site and are not counted as metastatic lesions)
- Solitary brain metastases and an untreated node positive primary tumor, without other extracranial metastases amenable to SBRT are ineligible
- Retreatment of previously irradiated tumor will be excluded per 3.1.9.2 above.
- Mediastinal lymph nodes involving multiple mediastinal nodal stations or N3 disease are ineligible.
- Pleural effusion known to be malignant or visible of chest xray.
- Untreated brain metastases
- Bilateral adrenal metastases
- Metastases in other sites not considered amenable to SBRT
- Patients with liver metastases cannot have received prior upper abdominal radiation
- Prior radiation to spine (most commonly in treatment of primary lung cancer), cannot have received >50Gy to the spinal cord at the level of current vertebral metastases
- Clinical or radiographic evidence of spinal cord compression are ineligible
- Patients with serious, uncontrolled, concurrent infection(s).
- Weight loss (>10% of body weight) in the prior 3 months.
- Pregnant or lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SBRT for metastatic NSCLC
SBRT for lung lesions, liver lesions, adrenal lesions, spinal lesions
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For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival
Time Frame: up to 2 years
|
Actuarial progression-free survival will be determined using the product-limit method of Kaplan and Meier and will be reported with an exact 95% confidence interval.
Using the RECIST criteria including progression of the protocol treated tumors, non-protocol treated tumors and the development of new metastatic disease.
Only protocol treated tumors will be determined by RECIST defined as complete lesion disappearance or <25%or original size; partial >30% decrease of target lesion; stable <30% decreased of target lesion and; local failure increase >20% of target lesion.
Non-protocol tumor progression will be determined by the treating physician.
Measured by imaging every 3 months.
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up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To Assess Physical Function for This Cohort of Patients
Time Frame: up to 3 months after treatment
|
Using the Vulnerable Elders Survey (VES-13) A 13-item self-reporting questionnaire includes age, self-rated health, limitations in physical function and disability to assess for deterioration of physical function/health.
Scoring for the VES-13 is as follows: Total scores are summed together based on self-rated health (0-1), physical function (0-2), functional disability (0-4), (range from 0 to 7).
A total score of 3 or more identifies participants as vulnerable to the risk of decline of physical function.
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up to 3 months after treatment
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Number of Participants With Local Control
Time Frame: up to 2 years
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Local control (LC) of SBRT-treated lesions will only be assessed in patients with at least 4-months of radiographic follow-up.
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up to 2 years
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Overall Survival
Time Frame: up to 4 years
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Overall survival will be reported with an exact 95% confidence interval.
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up to 4 years
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Impact of Treatment on Quality of Life (FACT-L)
Time Frame: up to 3 months after treatment
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Using the Functional Assessment of Cancer Therapy - Lung (FACT-L) a 36-item self-administered questionnaire evaluating physical, social/family, emotional, and functional well-being; subscales (symptoms, cognitive function, regret of smoking) on a five-point scale from 0 (not at all) to 4 (very much).
Maximum score 136.
Subscale scores added to obtain total score.
The higher the score the greater the impact on the quality of life.
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up to 3 months after treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2010
Primary Completion (Actual)
June 27, 2016
Study Completion (Actual)
June 27, 2016
Study Registration Dates
First Submitted
August 18, 2010
First Submitted That Met QC Criteria
August 19, 2010
First Posted (Estimate)
August 20, 2010
Study Record Updates
Last Update Posted (Actual)
November 29, 2019
Last Update Submitted That Met QC Criteria
November 11, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Adrenal Gland Diseases
- Carcinoma, Non-Small-Cell Lung
- Adrenal Gland Neoplasms
Other Study ID Numbers
- IRB00013994
- NCI-2010-01877 (Registry Identifier: CTRP)
- CCCWFU 62110 (Other Identifier: Wake Forest University Health Sciences)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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