Non Small Cell Lung Cancer Clinical Trial
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
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.
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.
;
Observational Model: Cohort, Time Perspective: Retrospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Recruiting |
NCT05707286 -
Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
|
||
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Completed |
NCT01945021 -
Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC
|
Phase 2 | |
Completed |
NCT04487457 -
Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
|
||
Terminated |
NCT04022876 -
A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection)
|
Phase 1 | |
Recruiting |
NCT05898763 -
TEIPP Immunotherapy in Patients With NSCLC
|
Phase 1/Phase 2 | |
Recruiting |
NCT05532696 -
Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
|
Phase 1/Phase 2 | |
Completed |
NCT04311034 -
A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03177291 -
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
|
Phase 1 | |
Terminated |
NCT03257722 -
Pembrolizumab + Idelalisib for Lung Cancer Study
|
Phase 1/Phase 2 | |
Completed |
NCT00349089 -
Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy
|
Phase 2 | |
Completed |
NCT05116891 -
A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04571632 -
Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Avelumab/Ipilimumab+ Dendritic Cells in Solid Tumors
|
Phase 2 | |
Terminated |
NCT03599518 -
DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
|
Phase 1 | |
Not yet recruiting |
NCT06020989 -
Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy
|
Phase 2 | |
Withdrawn |
NCT03982134 -
PDR001 + Panobinostat for Melanoma and NSCLC
|
Phase 1 | |
Withdrawn |
NCT03574649 -
QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer
|
Phase 2 | |
Withdrawn |
NCT02844140 -
DE-CT in Lung Cancer Proton Therapy
|
N/A | |
Completed |
NCT03780010 -
Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC
|
Phase 1 |