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Trial record 1 of 1 for:    NCT02038413
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State of the Art Photon Therapy Versus Particle Therapy for Small Lung Tumors; a Planning Study Based on a Reference Dataset of Patients (Lung stage I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02038413
Recruitment Status : Completed
First Posted : January 16, 2014
Last Update Posted : January 12, 2016
University of Pennsylvania
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Brief Summary:

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.

Condition or disease
Non Small Cell Lung Cancer

Detailed Description:

For this in silico planning study all treatment plans will be performed in centers that are already operating and have experience in treatment planning. IMRT treatment plans will be calculated in Eindhoven (NL), Tomotherapy plans in Deventer (NL), Cyberknife plans in Liege (BE) and RapidArc treatment plans in Hasselt (BE). Proton treatment plans will be performed at the University of Pennsylvania (USA) and the C-ion treatment plans at the University of Marburg (GE).

A dataset with state-of-the-art image data is available. 25 patients will be included according to a-priori defined selection criteria. Each patient will function as his or her own control. For this reason, the number of patients per tumor group can be limited to 25 patients per tumor group (power = 80%, alpha = 5%).

The datasets will be stored on a secure website hosted by MAASTRO. High quality CT-images will be used for radiotherapy treatment planning. Secondary image information such as FDG-PET and MRI will be used for GTV delineation. GTV and all relevant OARs will be delineated in MAASTRO (NL). The GTV to PTV margin will be determined by the individual institutes according to the treatment technique and treatment modality.

Photons will be planned with state of the art treatment techniques. Protons will be planned using active beam delivery with Intensity Modulated proton therapy (IMPT)and carbon-ions with a pencil beam delivery treatment planning technique with gantry. Each participating center will use its own treatment planning system according to standard practice at that center. The same tumor dose, overall treatment time (OTT) and an equal number of fractions will be used for all treatment modalities.

Photon, proton and C-ion treatments will be compared based on dosimetric parameters on normal tissues. DVH's will be calculated for the OARs. In addition, the NTCP for a fixed tumor dose will be determined. Cobalt Gy equivalent doses will be used when reporting the proton and carbon-ion dose. In the case of protons, a constant RBE value of 1.1 will be used for both the tumor and the normal tissues. The RBE of carbon-ions will be calculated based on the models used by the participating centers.

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official 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
Study Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

NSCLC stage I
Consecutive patients were identified from October 2009 onwards in MAASTRO clinic, Maastricht. All patients received respiratory gated CT (4DCT) scans. All were patients referred for primary radiotherapy or chemo radiation.

Primary Outcome Measures :
  1. Radiation exposure for organs at risk (OAR) in a stereotactic lung radiotherapy treatment. [ Time Frame: 1 year ]

    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.

Secondary Outcome Measures :
  1. The risk of side effects in the irradiated normal tissue [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of 25 NSCLC patients; stages I (cT1/cT2aN0M0). Consecutive patients were identified from October 2009 onwards in MAASTRO clinic, Maastricht. All patients received respiratory gated CT (4DCT) scans. All were patients referred for primary radiotherapy or chemo radiation.

Inclusion Criteria:

  • >18 years of age
  • referred for primary radiotherapy or chemo radiation
  • NSCLC stage I
  • received respiratory gated CT (4DCT) scans

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02038413

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MAASTRO clinic
Maastricht, Limburg, Netherlands, 6229 ET
Sponsors and Collaborators
Maastricht Radiation Oncology
University of Pennsylvania
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Principal Investigator: Philippe Lambin, MD, PhD Maastro Clinic, The Netherlands
Study Director: Esther Troost, PhD Maastro Clinic, The Netherlands
Study Director: Erik Roelofs Maastro Clinic, The Netherlands
Study Director: Esther Bloemen Maastro Clinic, The Netherlands
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Responsible Party: Maastricht Radiation Oncology Identifier: NCT02038413    
Other Study ID Numbers: ROCOCO Lung stage I
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016
Keywords provided by Maastricht Radiation Oncology:
Stereotactic lung treatment
age >18 years
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases