Stage I Non-Small Cell Lung CancerEarly Phase 1NCT02319889
Feasibility Study of SBRT Plus Chemotherapy for Non-Small Cell Lung Carcinoma
A Early Phase 1 study testing Stereotactic Body Radiotherapy, Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in people with Stage I Non-Small Cell Lung Cancer and Stage II Non-Small Cell Lung Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This pilot clinical trial studies stereotactic body radiation therapy followed by combination chemotherapy in treating patients with non-small cell lung cancer. Stereotactic body radiation therapy is a specialized radiation therapy that delivers one to five high doses of radiation directly to the tumor and may kill… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage I Non-Small Cell Lung Cancer, Stage II Non-Small Cell Lung Cancer
- What is being tested?
- Stereotactic Body Radiotherapy, Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2016to 19 Jan 2017
- Phase
- Early Phase 1
- 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 pathologic diagnosis of non-small cell lung carcinoma (NSCLC), by either histologic biopsy, or cytologic evidence; highly suspicious cytology (i.e. abnormal cells suspicious for malignancy) is acceptable, in the setting of a strongly positive computed tomography (CT)/positron emission tomography (PET) (standardized uptake value [SUV] > 5.0)
- Patients must be considered appropriate for stereotactic body radiation therapy (SBRT); this is determined on an individualized basis, by the prospective multidisciplinary tumor board, that includes representation from surgical, radiation and medical oncology; criteria for appropriateness for SBRT include all of the following:
- Stage I/II non-small cell lung carcinoma (NSCLC) - no evidence of distant metastases (patients with up to three lung nodules may be considered to have 'multiple primary' lung cancer rather than metastatic lung cancer and thus will be eligible; if a lymph node(s) ≥ 2 cm and/or PET-SUV ≥ 4.0 is identified, biopsy must be performed (and be negative) for the patient to be eligible; patients thought to have M1b disease, or malignant pleural/pericardial effusions are not eligible
- Staging including CT chest, PET/CT must be up-to-date, i.e. within 6 weeks prior to registration; brain imaging (contrast-enhanced magnetic resonance imaging [MRI] or CT) is suggested for all patients, but is only mandatory for patients with abnormal neurologic exam
- Tumor size ≤ 7 cm in greatest dimension based upon an up-to-date CT (and/or CT/PET) within 6 weeks prior to enrollment onto the study; radiation therapy treatment planning imaging is acceptable)
- The patient must not be a candidate for (or declines because of high risk) surgical resection because of medical comorbidity/risk; the patient must have undergone an evaluation by an experienced thoracic surgeon within 12 weeks prior to registration; standard justification criteria may include forced expiratory volume in 1 second (FEV1) < 40% predicted; predicted postoperative FEV1 ≤ 30% predicted; diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 60% predicted; pulmonary hypertension (estimated ≥ 40 mm Hg); poor cardiac function (ejection fraction [EF] ≤ 40%); Medical Research Council (MRC) dyspnea scale ≥ 3 (corresponds to inability to walk at least 100 yards without rest); baseline hypoxemia (partial pressure of oxygen [pO2] ≤ 55 mg HG and/or pulse oxygen [ox] < 88%), baseline hypercapnia (carbon dioxide [CO2] ≥ 45 mm Hg; there are also other, less objective criteria, including severe end-organ damage from diabetes/hypertension, severe atherosclerotic disease (heart, brain, aorta, peripheral artery)
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- Tumor(s) must be in a location/configuration such that risk of fistula is considered relatively low; this means that there can be no evidence of tumor invasion of a major (lobar/hilar) pulmonary vessel(s), aorta, vena cava, trachea or mainstem bronchus or esophagus; additional studies may be needed to assess this, including CT angiogram, MRI, bronchoscopy, esophagoscopy
- One or more of the following "risk" criteria for failure with conventional SBRT treatment alone:
- Peripheral tumor ≥ 4 cm in any dimension
- Central tumor (i.e. gross tumor within 2 cm of a major bronchus/vessel, or heart/pericardium), including hilar lymph node(s)
- Multiple tumors (i.e. satellitosis-defined T3-4, or bilateral synchronous primary lung cancer; note that the maximum number of total lesions allowable on this study for treatment with SBRT is 3 (Three), and all lesions must be amenable to SBRT and treated with SBRT on this study; note that it is not necessary for all lesions felt to be malignant to be biopsied
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Hemoglobin ≥ 9.0 g/dl
- Absolute neutrophil count ≥ 1,500/mcL
- Platelet count ≥ 100,000 cells/mcL
- Total bilirubin ≤ 1.5 X institutional upper limit of normal
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ≤ 2.5 X institutional upper limit of normal
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 X institutional upper limit of normal
- Serum creatinine ≤ 1.5 X institutional upper limit of normal
- Alkaline phosphatase ≤ 2.5 X institutional upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
- Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 6 weeks prior to study entry, for the duration of study participation and for 6 months after completing treatment; should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately
- Subjects must have the ability to understand and the willingness to sign a written informed consent document
- Patients must not have grade 2 or greater pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE] 4.0)
Who cannot join
- Prior treatment toxicities (i.e. any toxicity from treatment of a previous cancer ) must be resolved to ≤ grade 1 according to National Cancer Institute (NCI) CTCAE version 4.0 (except alopecia)
- Patients who are receiving any other investigational agents
- Patients with prior invasive malignancy within two years of enrollment are excluded
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Abraxane (paclitaxel albumin-stabilized nanoparticle formulation) or other agents used in this study
- Patients with severe cardiac disease including symptomatic congestive heart failure, unstable angina, or have experience an acute myocardial infarction within the past 6 months; please note: patients with chronic obstructive pulmonary disease (COPD) are not excluded
- Pregnant or breastfeeding women are excluded from this study; breastfeeding should be discontinued
- Known human immunodeficiency virus (HIV)-positive patients are ineligible
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
This pilot clinical trial studies stereotactic body radiation therapy followed by combination chemotherapy in treating patients with non-small cell lung cancer. Stereotactic body radiation therapy is a specialized radiation therapy that delivers one to five high doses of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue than conventional radiation. Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving stereotactic body radiation therapy, followed by carboplatin, and paclitaxel albumin-stabilized nanoparticle formulation may kill more tumor cells and result in a better and more durable response than conventional radiation and chemotherapy. The purpose of this study is to test the safety of this approach prior to larger studies.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the safety/feasibility of delivering chemotherapy after definitive stereotactic body radiation therapy (SBRT) for selected stage/situations of non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
- To determine the 1-year progression free survival in the sub-population of patients with stage IB/II NSCLC, i.e. the "curative intent" subgroup of patients.
OUTLINE:
Patients undergo stereotactic body radiation therapy every other day for up to 14 days for a total of 5 fractions. After a break period of about 30 days, patients will then start chemotherapy. Patients will receive carboplatin intravenously (IV) over 30-40 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30-40 minutes on days 1, 8, and 15. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 year.
- Being tested
- Stereotactic Body Radiotherapy, Carboplatin, Paclitaxel Albumin-Stabilized Nanoparticle Formulation
- 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 Body RadiotherapyRadiation
Also called SBRT, Stereotactic External Beam Irradiation, Stereotactic Radiation Therapy, Stereotactic Radiotherapy
Undergo SBRT
CarboplatinDrug
Also called Paraplatin
Given IV
Paclitaxel Albumin-Stabilized Nanoparticle FormulationDrug
Also called ABI 007, ABI-007, Abraxane
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (SBRT, carboplatin, Abraxane) | Experimental | Patients undergo Stereotactic Body Radiotherapy every other day for up to 14 days for a total of 5 fractions. After a break period of about 30 days, patients will then start chemotherapy. Patients will receive carboplatin IV over 30-40 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30-40 minutes on days 1, 8, and 15. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Receives: Radiation: Stereotactic Body Radiotherapy; Drug: Carboplatin; Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with prohibitive dose limiting toxicities
Number of participants that miss two or more cycles of treatment due to toxicities
Measured: Up to 1 year
Secondary outcomes (1)
1 year progression free survival (PFS)
Time-to-event data, such as PFS, will be analyzed using Kaplan-Meier method.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study start2 Feb 2016
- Primary completion6 Jul 2016
- Study completion19 Jan 2017
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mitchell Machtay, MD, Principal investigator, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319889
- Sponsor's protocol ID
- CASE2514
- Other IDs
- NCI-2014-02276, CASE 2514, P30CA043703
- Status last verified
- Jan 2017
- First submitted
- 11 Dec 2014
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of SBRT Plus Chemotherapy for Non-Small Cell Lung Carcinoma
- ClinicalTrials.gov ID
- NCT02319889
- Acronym / sponsor ID
- CASE2514
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding unavailable
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- 6 Jul 2016 (actual)
- Study completion
- 19 Jan 2017 (actual)
- First posted
- 18 Dec 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 stereotactic body radiation therapy followed by combination chemotherapy in treating patients with non-small cell lung cancer. Stereotactic body radiation therapy is a specialized radiation therapy that delivers one to five high doses of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue than conventional radiation. Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving stereotactic body radiation therapy, followed by carboplatin, and paclitaxel albumin-stabilized nanoparticle formulation may kill more tumor cells and result in a better and more durable response than conventional radiation and chemotherapy. The purpose of this study is to test the safety of this approach prior to larger studies.
Detailed description
PRIMARY OBJECTIVES:
- To determine the safety/feasibility of delivering chemotherapy after definitive stereotactic body radiation therapy (SBRT) for selected stage/situations of non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
- To determine the 1-year progression free survival in the sub-population of patients with stage IB/II NSCLC, i.e. the "curative intent" subgroup of patients.
OUTLINE:
Patients undergo stereotactic body radiation therapy every other day for up to 14 days for a total of 5 fractions. After a break period of about 30 days, patients will then start chemotherapy. Patients will receive carboplatin intravenously (IV) over 30-40 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30-40 minutes on days 1, 8, and 15. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (SBRT, carboplatin, Abraxane) | Experimental | Radiation: Stereotactic Body Radiotherapy, Drug: Carboplatin, Drug: Paclitaxel Albumin-Stabilized Nanoparticle FormulationPatients undergo Stereotactic Body Radiotherapy every other day for up to 14 days for a total of 5 fractions. After a break period of about 30 days, patients will then start chemotherapy. Patients will receive carboplatin IV over 30-40 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30-40 minutes on days 1, 8, and 15. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Patients must have pathologic diagnosis of non-small cell lung carcinoma (NSCLC), by either histologic biopsy, or cytologic evidence; highly suspicious cytology (i.e. abnormal cells suspicious for malignancy) is acceptable, in the setting of a strongly positive computed tomography (CT)/positron emission tomography (PET) (standardized uptake value [SUV] > 5.0)
- Patients must be considered appropriate for stereotactic body radiation therapy (SBRT); this is determined on an individualized basis, by the prospective multidisciplinary tumor board, that includes representation from surgical, radiation and medical oncology; criteria for appropriateness for SBRT include all of the following:
- One or more of the following "risk" criteria for failure with conventional SBRT treatment alone:
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Hemoglobin ≥ 9.0 g/dl
Key exclusion criteria (7 listed)
- Prior treatment toxicities (i.e. any toxicity from treatment of a previous cancer ) must be resolved to ≤ grade 1 according to National Cancer Institute (NCI) CTCAE version 4.0 (except alopecia)
- Patients who are receiving any other investigational agents
- Patients with prior invasive malignancy within two years of enrollment are excluded
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Abraxane (paclitaxel albumin-stabilized nanoparticle formulation) or other agents used in this study
- Patients with severe cardiac disease including symptomatic congestive heart failure, unstable angina, or have experience an acute myocardial infarction within the past 6 months; please note: patients with chronic obstructive pulmonary disease (COPD) are not excluded
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 RadiotherapyAlso: SBRT, Stereotactic External Beam Irradiation, Stereotactic Radiation Therapy, Stereotactic RadiotherapyUndergo SBRT | Radiation | Treatment (SBRT, carboplatin, Abraxane) |
| CarboplatinAlso: ParaplatinGiven IV | Drug | Treatment (SBRT, carboplatin, Abraxane) |
| Paclitaxel Albumin-Stabilized Nanoparticle FormulationAlso: ABI 007, ABI-007, AbraxaneGiven IV | Drug | Treatment (SBRT, carboplatin, Abraxane) |
Primary outcome
Number of participants with prohibitive dose limiting toxicities
Time frame: Up to 1 year
Number of participants that miss two or more cycles of treatment due to toxicities
1 secondary outcome
1 year progression free survival (PFS)
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Funding unavailable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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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.
Mitchell Machtay, MD principal investigator
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Stereotactic Body Radiotherapy, Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in people with Stage I Non-Small Cell Lung Cancer and Stage II Non-Small Cell Lung Cancer, run by Case Comprehensive Cancer Center 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 23 inclusion and 7 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 1 Feb 2017. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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: Funding unavailable). 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 participants with prohibitive dose limiting toxicities (time frame: Up to 1 year). 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 1 Feb 2017.