An Outcome Analysis for Stereotactic Body Radiation Therapy (SBRT) Treatment of Non-Small Lung Cancer Patients Using 4D PET/CT With Real-Time Position Management (RPM™) System and a Concomitant Evaluation of the Impact and Performance Characteristics of the Immobilization System

NCT02067858 | Terminated Results DMC

• 1 other identifier: 10-003
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this clinical research are to evaluate the outcomes and tumor response for early stage non-small lung cancer (NSCLC) patients undergoing Stereotactic Body Radiation Therapy (SBRT) using four dimensional (4D) Positron Emission Tomography (PET) and Computed Tomography (CT), Cone-Beam Computed Tomography (CBCT), Real-Time Position Management (RPM™) and body immobilization system (see figure 1). Specifically, the effect of image-guided SBRT treatment on clinical tumor response rate, local control and progression-free survival will be studied. This study will examine target volumes and relevant margins determined by an assessment using 4D PET and repeated 4D CT. These data will allow us to evaluate and determine the impact of the body immobilization system on the planning target volume (PTV) margins, patient's breathing pattern, target motion, and inter-treatment targets shifts.

Conditions

Non Small Cell Lung Cancer; 4D CT

Outcome Measures

Primary Outcomes (1)

• Assess Clinical Response Rate and Local Control Following SBRT Treatment of Patients With Early Stage NSCLC

  The Number of Patients that completed SBRT

  2 years

Secondary Outcomes (1)

• Assess Progression-free Survival

  2 years

Other Outcomes (1)

• Correlation of Imaging Response With Serum Protein and Peptide Profiles

  2 years

Study Arms (1)

Stereotactic Radiosurgery

OTHER

3 fractions x 20 Gy 4 fractions x 12 Gy Lesion dependent

Radiation: Stereotactic Radiosurgery

Interventions

Stereotactic Radiosurgery RADIATION

Also known as: SBRT, SRS, Trilogy, True Beam, Cyber Knife

Stereotactic Radiosurgery

Eligibility Criteria

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

The patient must be over the age of 18 years. Histologic confirmation of primary NSCLC of the lung tumor must be complete prior to SBRT treatment. The following stages of NSCLC patients would be eligible for the study: Stage I: T1 N0 M0 T2 N0 M0 (Size ≤ 5 cm) Stage II: T3 N0 M0 (Chest wall invasion only, Size ≤ 5 cm) Staging Tumor size and characteristics: they will be determined by PET-CT scan Nodal disease: Patients with chest CT scan demonstrating hilar or mediastinal nodes \<1cm and/or PET negative would be considered N0 disease. Patients who have hilar or mediastinal nodes \> 1 cm and PET scan negative may be considered N0 disease. If PET scan demonstrates suspicious uptake or abnormal uptake, these patients would be eligible, if a directed biopsy (by mediastinoscopy, Chamberlein procedure or other modalities such as trans-bronchial biopsy, CT guided biopsy) is negative. Metastases: Evaluated by PET-CT scanning and biopsy as indicated The patient must have an ECOG/Zubrod performance status of 0, 1, or 2. In order to be considered medically-inoperable, the patient must meet at least one major criterion or meet a minimum of 2 minor criteria as described below. MAJOR CRITERIA: FEV1 \< 50% or predicted postoperative FEV1 \< 40% DLCO \< 50% or predicted postoperative DLCO \< 40% Exercise induced maximal exercise oxygen consumption (MVO2)\<15 ml/kg/min Thoracic surgery consultation should be obtained from a Board Certified Thoracic surgeon who in collaboration with a radiation oncologist should determine if the patient is medically operable This criterion would be mandatory MINOR CRITERIA: Age \> 80 Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40mm Hg) Oxygen requirement (using the Medicare criteria for home oxygen requirements \[i.e., room air oxygen saturation of 88% or less\]) Congestive heart failure (any three of the following must be documented: dyspnea, peripheral edema, chest x-ray with interstitial edema or cardiomegaly, rales, or congestion) Poor left ventricular function (defined as an ejection fraction of 40% or less) Severe cerebral (with CVA or recent TIA) or severe peripheral vascular disease Diabetes Mellitus with severe organ damage such as End-Stage Renal Disease (ESRD), Blindness, Vascular disease. CBC, Diff and platelets, Comprehensive metabolic panel within 28 days of registration meeting the following criteria leukocytes \>3,000/mcL absolute neutrophil count \>1,500/mcL hemoglobin \>9 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors) platelets \>100,000/mcL total bilirubin \<1.5x institutional upper limit of normal creatinine within normal institutional limits OR creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. Females of child-bearing age must be using a reliable form of birth control. The patient must provide a signed and dated written informed consent PRIOR to registration and prior to undergoing any study-related procedures. The patient must provide written authorization to allow for the use and disclosure of their protected Health information. Conditions for Patient Ineligibility The patient's weight exceeds the tolerances of the institution's imaging and treatment platform/couch. The patient has received thoracic radiation therapy in the same region as the current SBRT planned treatment area. The patient has completed chemotherapy within 30 days of treatment. T2: Tumor size \> 5 cm, T3 tumors (except T3 by virtue of chest wall invasion and ≤ 5cm), T4 tumors. Presence of N1, N2 or N3 disease per previously described criteria would also be excluded. Pancoast tumors would be excluded. Current distant metastatic disease (M1) (preferably biopsy proven). The patient is a female with child-bearing potential who refuses to obtain a serum pregnancy test prior to the initiation of treatment. The patient is pregnant or a female who is nursing an infant. The patient is planning on undergoing systemic therapy within 2 weeks after the last fraction of radiation The patient has an active systemic or pulmonary infection.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Steven Burton: lead

Study Sites (1)

UPMC Shadyside Radiation Oncology Department

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Karen Holeva
• Organization: University of Pittsburgh

holevakd@upmc.edu

412-623-1275

Study Officials

• Dwight E Heron, MD

  University of Pittsburgh

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 20, 2014
• Study Start: April 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 18, 2018
• Results First Posted: July 18, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)