Breast Cancer Clinical Trial
Official title:
Evaluation of CPAP (Continuous Positive Airway Pressure) in the Planning of Radiation Treatments for Lung, Upper Abdomen and Left Breast Cancers
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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