PET-Adjusted Intensity Modulated Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II-IV Non-small Cell Lung Cancer

NCT02073968 | Completed Phase 2 Results DMC FDA Device

• 3 other identifiers: 2013-252NCI-2014-00216P30CA013330
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

This phase II trial studies how well intensity modulated radiation therapy adjusted by positron emission tomography (PET) scanning together with combination chemotherapy works in treating patients with stage II-IV non-small cell lung cancer (NSCLC). Radiation therapy uses high energy x rays to kill tumor cells. In intensity-modulated radiotherapy, multiple beam angles and dozens of beam segments are used to deliver highly conformal radiation therapy. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving PET-adjusted IMRT together with combination chemotherapy may kill more tumor cells.

Conditions

Metastatic Malignant Neoplasm in the Brain; Recurrent Non-Small Cell Lung Carcinoma; Stage IIA Non-Small Cell Lung Carcinoma; Stage IIB Non-Small Cell Lung Carcinoma; Stage IIIA Non-Small Cell Lung Cancer; Stage IIIB Non-Small Cell Lung Cancer; Stage IV Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Metabolic Response of All Pulmonary Lesions and Thoracic Lymph Nodes

  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 Outcomes (6)

• Incidence of Grade >= 2 Radiation-induced Lung Toxicity, Scored Using Common Terminology Criteria for Adverse Events (CTCAE), Version (v.) 4

  Up to 5 years

• Incidence of Grade >= 3 Treatment-related Toxicity, Scored Using CTCAE, v. 4

  Up to 5 years

• Locoregional Progression-free Survival Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

  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

  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

  From study registration to death, censored at the date of data collection, assessed at 1 year

Study Arms (1)

Treatment (PET-adjusted IMRT, carboplatin, paclitaxel)

EXPERIMENTAL

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.

Drug: Carboplatin; Procedure: Computed Tomography; Radiation: Intensity-Modulated Radiation Therapy; Drug: Paclitaxel; Procedure: Positron Emission Tomography; Radiation: Proton Beam Radiation Therapy

Interventions

Carboplatin DRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplat, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Treatment (PET-adjusted IMRT, carboplatin, paclitaxel)

Computed Tomography PROCEDURE

Undergo PET-adjusted IMRT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography

Treatment (PET-adjusted IMRT, carboplatin, paclitaxel)

Intensity-Modulated Radiation Therapy RADIATION

Undergo PET-adjusted IMRT

Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy

Treatment (PET-adjusted IMRT, carboplatin, paclitaxel)

Paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Treatment (PET-adjusted IMRT, carboplatin, paclitaxel)

Positron Emission Tomography PROCEDURE

Undergo PET-adjusted IMRT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Treatment (PET-adjusted IMRT, carboplatin, paclitaxel)

Proton Beam Radiation Therapy RADIATION

Undergo proton beam radiation therapy

Treatment (PET-adjusted IMRT, carboplatin, paclitaxel)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467-2490, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Radiotherapy, Intensity-Modulated; Paclitaxel; Taxes; Magnetic Resonance Spectroscopy; Proton Therapy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Heavy Ion Radiotherapy

Results Point of Contact

• Title: Dr. Nitin Ohri
• Organization: Montefiore Medical Center / Albert Einstein College of Medicine

nitin.ohri@einsteinmed.edu

718-920-7750

Study Officials

• Nitin Ohri

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: February 28, 2014
• Study Start: July 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: November 1, 2020
• Last Updated: January 25, 2024
• Results First Posted: January 22, 2020

Record last verified: 2024-01

Locations

US (2)