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Feasibility Study of SBRT Plus Chemotherapy for Non-Small Cell Lung Carcinoma | Clinical Trials | Clareo Health

TERMINATEDEARLY_PHASE1

Feasibility Study of SBRT Plus Chemotherapy for Non-Small Cell Lung Carcinoma

NCT02319889•Case Comprehensive Cancer Center

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 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: I. 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: I. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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:

Exclusion Criteria

•* 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)
•* 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
+17 more criteria

Locations (1)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Key Dates

Start Date

February 2, 2016

Primary Completion Date

July 6, 2016

Completion Date

January 19, 2017

Last Updated

February 1, 2017

Enrollment

ACTUAL participants

Conditions

Stage I Non-Small Cell Lung CancerStage II Non-Small Cell Lung Cancer

Interventions

Stereotactic Body Radiotherapy

RADIATION

Carboplatin

DRUG

Paclitaxel Albumin-Stabilized Nanoparticle Formulation

DRUG

Image-Guided, Intensity-Modulated Photon or Proton Beam Radiation Therapy in Treating Patients With Stage II-IIIB Non-small Cell Lung Cancer

NCT01629498

Recurrent Lung Non-Small Cell CarcinomaStage II Non-Small Cell Lung Cancer AJCC v7+4 more

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ACTIVE_NOT_RECRUITINGPHASE3

Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer

NCT01993810

Stage II Non-Small Cell Lung Cancer AJCC v7Stage IIA Non-Small Cell Lung Carcinoma AJCC v7+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Feasibility Study of SBRT Plus Chemotherapy for Non-Small Cell Lung Carcinoma

Inclusion Criteria

Exclusion Criteria

Image-Guided, Intensity-Modulated Photon or Proton Beam Radiation Therapy in Treating Patients With Stage II-IIIB Non-small Cell Lung Cancer

Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer

Cisplatin, Docetaxel, and Nintedanib Before Surgery in Treating Patients With Previously Untreated Stage IB-IIIA Non-small Cell Lung Cancer