Non Small Cell Lung Cancer Clinical Trial
— Lung stage IOfficial title:
In Silico Clinical Trial, Comparing State of the Art Photon Modalities With Proton and 12C-ion Therapy for Stage I NSCLC: A Multicentric ROCOCO Planning Study Based on a Reference Dataset of Patients
Compared to conventional radiotherapy with photons (CRT), particle therapy (PT) has the
potential to inflict maximum damage on tumors with minimum collateral damage to neighboring
healthy tissue. Given that the cost of particle therapy (PT) is considerably higher than
that of conventional radiotherapy (RT) with photons, it is necessary to establish whether
these higher costs are worthwhile in light of the expected advantages. Thus, clear evidence
of the situations in which PT outperforms conventional photon treatment is needed.
In a previous ROCOCO study (lung stage I-IIIB) an inhomogeneous group of patients with
regard to tumor stage and size was included1. Conformal radiotherapy and Intensity Modulated
Radiotherapy were used in the comparison. In this study patients with smaller tumors are
included (stage I). A stereotactic treatment schedule and more advanced treatment
techniques, such as CyberKnife, RapidArc, IMRT and Tomotherapy, are eligible for these kind
of lesions. As a result the comparison as demonstrated in our previous study maybe invalid.
We propose to investigate to what extend proton and 12C-ion therapy decrease the amount of
irradiated normal tissue compared to state of the art photon modalities in stage I lung
cancer patients.
Status | Completed |
Enrollment | 25 |
Est. completion date | January 2016 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - >18 years of age - referred for primary radiotherapy or chemo radiation - NSCLC stage I - received respiratory gated CT (4DCT) scans |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Netherlands | MAASTRO clinic | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht Radiation Oncology | University of Pennsylvania |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Radiation exposure for organs at risk (OAR) in a stereotactic lung radiotherapy treatment. | A wide range of organs is included, to be able to document doses to organs that are further away from the target volume, and also to quantify low doses to organs. Included OAR's are; left lung, right lung, (part of the) ribs if less then 2 cm from the CTV, for non-apical tumors: liver, spinal canal resembling the spinal cord, esophagus (full length), trachea, and main bronchi up to the first bifurcation, skin (with a thickness of standardized 4 mm), thyroid area, heart, mediastinal great vessels (aorta, vena cava, main lung arteries, ...), portacath, pacemaker (or any other implanted device to be avoided), brachial plexus and stomach. |
1 year | No |
Secondary | The risk of side effects in the irradiated normal tissue | 1 year | No |
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