search
Back to results

Evaluation of Continuous Positive Airway Pressure for Tumor Motion Management in Radiotherapy

Primary Purpose

Tumor Motion, "Continuous Positive Airway Pressure", Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Continuous positive airway pressure (CPAP)
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tumor Motion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Lung tumors and nodules with tumor motion greater than 1 cm on standard imaging
  • Left sided breast tumors with unfavorable anatomy, viz heart abutting chest wall
  • Upper abdominal tumors: Liver and Pancreas with tumor motion greater than 1 cm. (n=10)

Exclusion Criteria:

  • Under 18 years old
  • Inability to sign informed consent
  • Pregnancy,
  • Mental Illness,
  • Not legally competent

Sites / Locations

  • Sheba_Medical_CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Lung tumors

Left sided Breast cancer

Abdominal tumors

Arm Description

Patients with > 1 cm tumor motion simulated using 4DCT with and without CPAP

Patients with heart abutting chest wall will be simulated using 4DCT with and without CPAP

Patient with liver metastases for SBRT or pancreatic tumors will be simulated using 4DCT with and without CPAP

Outcomes

Primary Outcome Measures

Reduction in amplitude of tumor motion
Measurement of the Internal Target Volume in cc

Secondary Outcome Measures

Reduction of radiation dose to critical organs
Mean Lung dose, Mean Heart dose measured in Gy

Full Information

First Posted
December 10, 2014
Last Updated
December 18, 2014
Sponsor
Sheba Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02324530
Brief Title
Evaluation of Continuous Positive Airway Pressure for Tumor Motion Management in Radiotherapy
Official Title
Evaluation of CPAP (Continuous Positive Airway Pressure) in the Planning of Radiation Treatments for Lung, Upper Abdomen and Left Breast Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a clinical study on patients to compare the effects of CPAP on lung volume diaphragm motion, heart position and tumor motion compared to free breathing. Only patients with significant tumor motion of greater than 1 cm amplitude or unfavorable chest wall geometry (heart close to chest wall) identified on standard imaging and simulation will be candidates for the study. Patients will be re- simulated and planned for radiation treatments with CPAP. The radiation plans generated with and without CPAP will be compared to evaluate the impact of CPAP on tumor motion and dose delivered to adjacent critical structures such as the heart and lung.
Detailed Description
Primary Objectives Evaluate effectiveness of CPAP to reproducibly reduce tumor and organ motion during radiation therapy treatments. Determine if CPAP allows for a reduction in normal tissue receiving radiation in chest and abdomen tumors and reduce heart exposure for patients receiving left breast irradiation. Entry Criteria: This is a proof of concept and feasibility study. We propose to study 10 patients in each group for a total of thirty patients. Eligibility criteria Group1. Lung tumors and nodules with tumor motion greater than 1 cm on standard imaging (n=10) Group2. Left sided breast tumors with unfavorable anatomy, viz heart abutting chest wall (n=10) Group3. Upper abdominal tumors: Liver and Pancreas with tumor motion greater than 1 cm. (n=10) Pretreatment evaluations/management for patients meeting eligibility criteria CPAP All patients will be evaluated by a pulmonologist for their respiratory performances including physical examination, oxygen saturation and pulmonary function tests including DLCO that will serve for baseline measures. Then, adjustment session will be performed aiming to get adjusted to a CPAP device till the maximal tolerated pressure is not more than 16 cmH20 (TBD) for 30 minutes. All patients must be able to tolerate CPAP and comply with daily treatment. 4D CT: CT simulation is the basis of conformal treatment planning [24, 25]. By using a slow acquisition time of 3 minutes the motion effects due to breathing can be captured and a 4D image generated. The tumor position can be imaged throughout the breathing cycle and a Maximum Intensity Projection (MIP) can be constructed and used in treatment planning. If there is no tumor motion the size of the MIP would equal the tumor size. The MIP size will increase with increasing tumor motion. The planning software allows us to calculate the MIP dimensions and volume. In addition total lung volumes and change in diaphragm position can be calculated (Figure 1). Radiation therapy planning parameters and volumetric analysis of tumor and normal tissue motion and position are calculated using available software and transferred to the Eclipse treatment planning system [17]. Treatment Planning: The Eclipse treatment planning system will be used to generate and compare plans for treatment with and without CPAP. Details of Intervention Simulation All treatment planning and CPAP evaluation will be done in the radiation therapy department. Patients will be simulated on the Phillips 4D big bore CT simulator. The 4D scan which is done slowly over several minutes allows us to assess the full range of tumor motion throughout the respiratory cycle. An ITV is calculated which includes the actual tumor size with an expansion to account for the range of motion of the tumor by accounting for tumor location throughout the respiratory cycle (MIP) The MIP is the basis for the ITV and is the structure used for treatment planning. Patients recruited for the study will be re-simulated with the patient in the same position while undergoing CPAP treatment. ITV size and volume will be calculated for the tumor in in both the standard and CPAP studies and used for planning. RPM: Diaphragm motion and respiratory cycle information will be obtained using the RPM for both the standard and the CPAP simulations. Differences in the respiratory wave cycle will be recorded [17]. The MIP/ITV images will be transferred to the Eclipse treatment planning system and using both the standard breathing and CPAP simulations treatment plans will be generated. Standard radiation plan evaluation parameters will be used and plans compared with respect to tumor coverage and normal tissue and normal tissue in the radiation field. Radiation Plan: Identical field arrangements will be generated for CPAP and non CPAP plans. Plans will be evaluated using standard radiation therapy planning parameters including: MIP or ITV, total lung volume, volume of GTV/CTV/PTV/ V20 and MLD. Pre treatment Compare standard conformal radiation plans using Eclipse treatment planning system for each patient with and without CPAP. RPM tracings with and without CPAP will be compared for all groups pre- treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor Motion, "Continuous Positive Airway Pressure", Lung Cancer, Breast Cancer, Abdominal Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lung tumors
Arm Type
Experimental
Arm Description
Patients with > 1 cm tumor motion simulated using 4DCT with and without CPAP
Arm Title
Left sided Breast cancer
Arm Type
Experimental
Arm Description
Patients with heart abutting chest wall will be simulated using 4DCT with and without CPAP
Arm Title
Abdominal tumors
Arm Type
Experimental
Arm Description
Patient with liver metastases for SBRT or pancreatic tumors will be simulated using 4DCT with and without CPAP
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure (CPAP)
Intervention Description
CT simulation with and without CPAP
Primary Outcome Measure Information:
Title
Reduction in amplitude of tumor motion
Description
Measurement of the Internal Target Volume in cc
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Reduction of radiation dose to critical organs
Description
Mean Lung dose, Mean Heart dose measured in Gy
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
Tolerability of CPAP
Description
Percentage of patients who tolerate CPAP
Time Frame
immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Lung tumors and nodules with tumor motion greater than 1 cm on standard imaging Left sided breast tumors with unfavorable anatomy, viz heart abutting chest wall Upper abdominal tumors: Liver and Pancreas with tumor motion greater than 1 cm. (n=10) Exclusion Criteria: Under 18 years old Inability to sign informed consent Pregnancy, Mental Illness, Not legally competent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zvi Symon, MD
Phone
97235308175
Email
symonz@sheba.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Hila Genesin, MsC
Phone
972527738123
Email
Hila.Gnessin@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zvi Symon, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Goldstein, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yaacov R Lawrence, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba_Medical_Center
City
Tel Hashomer
ZIP/Postal Code
5262160
Country
Israel
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Continuous Positive Airway Pressure for Tumor Motion Management in Radiotherapy

We'll reach out to this number within 24 hrs