DE-CT in Lung Cancer Proton Therapy (DE-CT)
Primary Purpose
Non Small Cell Lung Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
DE-CT's and SE-CT
Sponsored by
About this trial
This is an interventional other trial for Non Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced stage IIIA or III B (T0-4 N2-3M0) NSCLC, or M1 oligometastatic disease according to 7th TNM classification.
- Scheduled to receive concurrent chemotherapy and radiotherapy to a dose of at least 60 Gy, as decided at the multidisciplinary tumour board
- Able to give written informed consent
- Able to have adequate contraception in woman with child bearing potential
Exclusion Criteria:
- Not able to give written informed consent
- Not able to comply with adequate contraception in woman with child bearing potential
Sites / Locations
- MAASTRO clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Scans
Arm Description
Patients included in the trial will receive DE-CT in stead of SE-CT's.
Outcomes
Primary Outcome Measures
Dose distribution on the CTV (measured in Gy)
Dose distribution on the CTV (clinical target volume) of the tumour and the lymph nodes of DE-CT vs. SE-CT
Dose distribution on the OAR (measured in Gy)
Dose distribution on the OAR (organs at risk), lungs, heart, aorta, pulmonary artery, superior vena cava, oesophagus, spinal cord, vertebral body, of DE-CT vs. SE-CT
Secondary Outcome Measures
Full Information
NCT ID
NCT02844140
First Posted
July 19, 2016
Last Updated
April 13, 2017
Sponsor
Maastricht Radiation Oncology
1. Study Identification
Unique Protocol Identification Number
NCT02844140
Brief Title
DE-CT in Lung Cancer Proton Therapy
Acronym
DE-CT
Official Title
DE-CT vs. SE-CT as Optimal Imaging During Treatment for Adaptive Proton Therapy in Stage III Non Small Cell Lung Cancer (NSCLC)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Withdrawn
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht Radiation Oncology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Dose distribution calculations for proton therapy are more accurate when based on DE-CT than on SE-CT. It is however unclear what the quantitative benefit of repeated DE-CT calculations is for lung cancer patients.
Detailed Description
In order to calculate the dose distribution of protons adequately, accurate estimations of the stopping power ratio (SPR) medium to water, are required. Using a conversion from single energy CT (SE-CT) images results in an uncertainty in the SPR of at least 3-4%. This uncertainty results in in the use of larger margins around the clinical target volume (CTV) and hence more dose to the organs at risk (OAR). It also effects in the conservative use of beam directions, which are often sub-optimal, to avoid irradiating normal tissues.
Dual energy CT (DE-CT) improves the accuracy of the SPR and therefore the proton range estimation.
An evaluation of the proton range for several tissues using SE-CT and DE-CT as input to Monte Carlo (MC) simulations showed on average improvements in range prediction from 0.1% to 2.1% when using DECT instead of SECT, but in several phantoms and also versus proton-CT, the errors on SE-CT based proton stopping power ratios are reported to be more than 7 %.
A limitation of these studies is that most of them were performed in phantoms. In the first clinical data set on five patients with base of skull tumours, it was reported that although the SPR estimation was indeed better for DE-CT than for SE-CT, its clinical relevance was unclear. However, in the same study, phantom measurements showed a large uncertainty of the SPR in the lung. This is due to the large heterogeneity of the lungs and the huge difference in the density of the lungs compared to the mediastinum, the tumour and the chest cavity.
It is therefore important to study the SPR differences of SE-CT compared to DE-CT in lung cancer patients and the impact on the dose distribution especially in the context of adaptive radiotherapy. As during the course of concurrent chemotherapy and radiotherapy, which is the standard treatment in the majority of stage III lung cancer patients, important anatomical changes may occur, it is also of clinical relevance to determine the influence of repeated dose calculations on DE-CT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Scans
Arm Type
Experimental
Arm Description
Patients included in the trial will receive DE-CT in stead of SE-CT's.
Intervention Type
Procedure
Intervention Name(s)
DE-CT's and SE-CT
Intervention Description
Patients included in the trial will receive 3 extra DE-CT's and 3 extra SE-CT's
Primary Outcome Measure Information:
Title
Dose distribution on the CTV (measured in Gy)
Description
Dose distribution on the CTV (clinical target volume) of the tumour and the lymph nodes of DE-CT vs. SE-CT
Time Frame
Measured during 2nd and 4th week of radiation treatment
Title
Dose distribution on the OAR (measured in Gy)
Description
Dose distribution on the OAR (organs at risk), lungs, heart, aorta, pulmonary artery, superior vena cava, oesophagus, spinal cord, vertebral body, of DE-CT vs. SE-CT
Time Frame
Measured during 2nd and 4th week of radiation treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed locally advanced stage IIIA or III B (T0-4 N2-3M0) NSCLC, or M1 oligometastatic disease according to 7th TNM classification.
Scheduled to receive concurrent chemotherapy and radiotherapy to a dose of at least 60 Gy, as decided at the multidisciplinary tumour board
Able to give written informed consent
Able to have adequate contraception in woman with child bearing potential
Exclusion Criteria:
Not able to give written informed consent
Not able to comply with adequate contraception in woman with child bearing potential
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk De Ruysscher, MD, PhD
Organizational Affiliation
Maastro Clinic, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
MAASTRO clinic
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 ET
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
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DE-CT in Lung Cancer Proton Therapy
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