- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02073968
PET-Adjusted Intensity Modulated Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II-IV Non-small Cell Lung Cancer (PAINT)
PET-Adjusted IMRT for NSCLC Trial (PAINT)
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. To estimate the efficacy (based on post-treatment PET findings) of dose-painted intensity-modulated radiotherapy (IMRT) with concurrent chemotherapy for locally-advanced non-small cell lung cancer (LA-NSCLC).
SECONDARY OBJECTIVES:
I. To estimate the efficacy (based on clinical endpoints including locoregional control [LRC], disease-free survival [DFS], and overall survival [OS]) of dose-painted IMRT with concurrent chemotherapy for LA-NSCLC.
II. To evaluate the safety of dose-painted IMRT with concurrent and adjuvant chemotherapy for LA-NSCLC.
III. To evaluate the utility of post-treatment PET/computed tomography (CT) imaging as a predictor of clinical outcomes following treatment with this novel approach.
IV. To explore, in a preliminary manner, whether metabolomic markers in the blood and urine prior to and during the course of treatment are associated with treatment response, clinical endpoints, and treatment-related adverse events such as radiation pneumonitis.
OUTLINE:
RADIATION THERAPY: Patients undergo PET-adjusted IMRT or proton beam radiation therapy five days a week for 5 weeks.
CONCURRENT CHEMOTHERAPY: Patients receive carboplatin intravenously (IV) over 3 hours and paclitaxel IV over 1 hour once weekly for 5 weeks beginning week 1 of thoracic radiotherapy.
CONSOLIDATION CHEMOTHERAPY: Beginning approximately 4-6 weeks after the completion of all radiation therapy and when esophagitis and chemotherapy-induced neuropathy are grade 1 or less, absolute neutrophil count (ANC) > 1500, and platelet count > 100,000, patients may receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment may repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity at the discretion of the treating physicians.
After completion of study treatment, patients are followed up at 12-16 weeks, 19 weeks, every 3 months for 2 years, and then every 6 months for a total of 5 years.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States, 10461
- Albert Einstein College Of Medicine
-
Bronx, New York, United States, 10467-2490
- Montefiore Medical Center - Moses Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Pathologically proven (either histologic or cytologic) diagnosis of NSCLC with any of the following stages (according to the American Joint Committee on Cancer [AJCC] Staging Manual, 7th edition):
- Stage IIIA or IIIB
- Stage II NSCLC with medical contraindication to curative surgical resection
- Stage IV disease with solitary brain metastasis that has been treated radically (eg: with surgical resection or stereotactic radiosurgery) and thoracic disease that would be classified as stage II-III
Appropriate diagnostic/staging workup, including:
- Complete history and physical examination
- Whole body PET/computed tomography (CT) scan within 42 days prior to study entry demonstrating hypermetabolic pulmonary lesion(s) and/or thoracic lymph node(s), with a maximum standardized uptake volume (SUV) > 6 for at least one lesion; if PET/CT was obtained more than 42 days prior to study entry and is not repeated, CT scan of the chest within 28 days prior to study entry demonstrating stable disease is required
- Magnetic resonance imaging (MRI) of the brain or CT scan of the head with contrast within 42 days prior to study entry
- Biopsy confirmation of suspected metastatic disease identified by PET/CT is recommended
- Pulmonary function tests (PFTs) within 6 weeks of study entry are highly recommended but not required
- No prior chemotherapy or thoracic radiotherapy for lung cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) >= 1,500 cells/ul
- Platelets >= 100,000 cells/ul
- Hemoglobin >= 9.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 9.0 g/dl is acceptable)
- Total bilirubin < 3.0 times the institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x the ULN
- Serum creatinine =< 1.5 x ULN or calculated creatinine clearance >= 50 ml/min (by Cockroft-Gault formula)
Women of childbearing potential must:
- Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy
- Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed
- Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
- All patients must sign study specific informed consent prior to study entry
Exclusion Criteria:
Pleural or pericardial effusion
- A patient with pleural effusion may be enrolled the effusion is sampled by thoracentesis and cytology is negative or the effusion is seen on axial imaging but not on chest x-ray and deemed too small to tap under CT or ultrasound guidance
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
Women who
- Are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study therapy
- Have a positive pregnancy test at baseline
- Are pregnant or breastfeeding
- Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications; patients with diabetes will preferably be scheduled for PET/CT imaging in the morning, and instructions for fasting and use of medications will be provided in consultation with the patients' primary physicians
Study Plan
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: Treatment (PET-adjusted IMRT, carboplatin, paclitaxel)
RADIOTHERAPY: Patients undergo PET-adjusted IMRT or proton beam radiation therapy five days a week for 5 weeks. CONCURRENT CHEMOTHERAPY: Patients receive carboplatin IV over 3 hours and paclitaxel IV over 1 hour once weekly for 6 weeks beginning week 1 of thoracic radiotherapy. CONSOLIDATION CHEMOTHERAPY: Beginning approximately 4-6 weeks after the completion of all radiation therapy and when esophagitis and chemotherapy-induced neuropathy are grade 1 or less, ANC > 1500, and platelet count > 100,000, patients may receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment may repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity at the discretion of the treating physicians. |
Given IV
Other Names:
Given IV
Other Names:
Undergo PET-adjusted IMRT
Other Names:
Undergo PET-adjusted IMRT
Other Names:
Undergo PET-adjusted IMRT
Other Names:
Undergo proton beam radiation therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic Response of All Pulmonary Lesions and Thoracic Lymph Nodes
Time Frame: Up to 16 weeks after completion of radiation therapy
|
Favorable response will be defined as having maximum SUV less than 6.0 on post-treatment PET/CT.
|
Up to 16 weeks after completion of radiation therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Grade >= 2 Radiation-induced Lung Toxicity, Scored Using Common Terminology Criteria for Adverse Events (CTCAE), Version (v.) 4
Time Frame: Up to 5 years
|
Incidence of grade >= 2 radiation-induced lung toxicity, scored using Common Terminology Criteria for Adverse Events (CTCAE), version (v.) 4, will be presented as frequency and percentages.
|
Up to 5 years
|
Incidence of Grade >= 3 Treatment-related Toxicity, Scored Using CTCAE, v. 4
Time Frame: Up to 5 years
|
Incidence of grade >= 3 treatment-related toxicity, scored using CTCAE, v. 4, will be presented as frequency and percentages.
|
Up to 5 years
|
Locoregional Progression-free Survival Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Time Frame: From study registration to date of local or regional disease progression or death, censored at the date of data collection, assessed at 1 year
|
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Kaplan-Meier survival plots will be produced. The survival probabilities will be presented. |
From study registration to date of local or regional disease progression or death, censored at the date of data collection, assessed at 1 year
|
Lung Cancer Cause-specific Survival
Time Frame: From study registration to death directly from lung cancer, censored at the date of data collection, up to a maximum of 5 years
|
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions A patient will be considered to have died from lung cancer if he or she had evidence of disease progression at any site and no direct evidence of other cause of death. Kaplan-Meier survival plots will be produced. |
From study registration to death directly from lung cancer, censored at the date of data collection, up to a maximum of 5 years
|
Overall Survival
Time Frame: From study registration to death, censored at the date of data collection, assessed at 1 year
|
Kaplan-Meier survival plots will be produced.
The survival probabilities will be presented.
Log-rank testing will be used to compare the survival probabilities between categorical predictors.
A Cox regression model will be used to estimate the hazard rates for overall survival among the predictor variables.
|
From study registration to death, censored at the date of data collection, assessed at 1 year
|
Progression-free Survival Assessed Using the RECIST Criteria
Time Frame: From study registration to date of disease progression or death, censored at the date of data collection, assessed at 1 year
|
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Kaplan-Meier survival plots will be produced. The survival probabilities will be presented. Log-rank testing will be used to compare the survival probabilities between categorical predictors. A Cox regression model will be used to estimate the hazard rates for progression free survival among the predictor variables. |
From study registration to date of disease progression or death, censored at the date of data collection, assessed at 1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nitin Ohri, Albert Einstein College Of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- 2013-252 (Other Identifier: Albert Einstein College of Medicine)
- P30CA013330 (U.S. NIH Grant/Contract)
- NCI-2014-00216 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Stage IIIA Non-Small Cell Lung Cancer
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon... and other conditionsUnited States
-
Peking UniversityMerck Sharp & Dohme LLC; Cancer Institute and Hospital, Chinese Academy of... and other collaboratorsRecruitingStage IIIA Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung Cancer | Stage IIIB(N2) Non-small Cell Lung CancerChina
-
Washington University School of MedicineActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Stage IIB Non-Small Cell Lung Cancer | Stage IIIC Non-Small Cell Lung CancerUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteNestle Health ScienceWithdrawnNSCLC | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | NSCLC Stage IIIB | Non-small Cell Lung Cancer Stage IIIB | NSCLC, Stage IIIA | Non-small Cell Lung Cancer Stage ⅢAUnited States
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
Memorial Sloan Kettering Cancer CenterAstraZenecaRecruitingNSCLC | Lung Cancer | Non-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | PD-L1 Gene Mutation | Non-small Cell Lung Cancer Stage IIIA | Non-small Cell Lung Cancer Stage IIUnited States
Clinical Trials on Carboplatin
-
Eisai Inc.CompletedCancerUnited States, Austria, India
-
Samyang Biopharmaceuticals CorporationCompleted
-
NHS Greater Glasgow and ClydeCompletedOvarian Cancer | Fallopian Tube Cancer | Primary Peritoneal Cavity CancerUnited Kingdom, Australia, New Zealand
-
Duke UniversityCompletedBrain and Central Nervous System TumorsUnited States, Canada
-
National Cancer Institute (NCI)CompletedBreast Cancer | Ovarian CancerUnited States
-
National Cancer Institute (NCI)Children's Oncology GroupCompletedBrain and Central Nervous System TumorsUnited States, Canada, Puerto Rico, Australia, Netherlands, New Zealand, Switzerland
-
All India Institute of Medical Sciences, New DelhiCouncil of Scientific and Industrial Research, IndiaUnknownIntraocular RetinoblastomaIndia
-
AkesoRecruitingAdvanced Squamous Non Small Cell Lung CancerChina
-
MEI Pharma, Inc.CompletedPeritoneal Neoplasms | Ovarian Cancer | Fallopian Tube CancerUnited States, Spain, Belgium, United Kingdom, Australia, Italy, Poland
-
Medical Research CouncilEuropean Organisation for Research and Treatment of Cancer - EORTCCompletedTesticular Germ Cell TumorUnited Kingdom, Canada, Norway, Netherlands, South Africa, Brazil, Finland