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Chordoma

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

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Cobalt

Participants treated to 70 cobalt Gray equivalent (CGE) only (the standard treatment).

Proton beam therapy combined with photon radiation therapy where combination improves final dose distribution.

70 Gy once daily at 2 CGE per fraction, no sooner than 2 weeks after last surgery to remove tumor, for between 35-39 treatments.

Proton Beam Therapy

Photon beam therapy once daily, no sooner than 2 weeks after last surgery to remove tumor, for 35-39 treatments.

Photon Beam Therapy

David Grosshans, MD, PHD

The goal of this clinical research study is to learn if proton beam therapy, with or without photon beam radiation therapy, is effective in the treatment of skull base chordoma. The safety of this treatment will also be studied.

Proton therapy is a kind of external beam radiation therapy where protons are directed to a tumor site. Researchers are trying to determine what level of proton therapy gives the most benefit without causing toxic side effects. Researchers will also be testing the treatment's effect.

If your doctor feels it is necessary, the proton beam therapy may be combined with standard photon therapy.

If you are eligible to take part in this study, you will receive proton beam therapy at The University of Texas (UT) MD Anderson Cancer Center (MDACC), and possibly photon beam, no sooner than 2 weeks after the last surgery to remove the tumor. You will receive proton beam therapy once a day for about 35 treatments (7 weeks). Treatment will be given for 5 days in a row each week (except for Saturdays, Sundays and holidays) at the MDACC Proton Center in Houston. The whole process should take up to 1 hour each day.

This is an investigational study. The proton beam machine used to deliver treatment is approved by the FDA for patient use. The doses being studied are experimental. About 15 participants will take part in this study. All will be enrolled at MDACC.

Proton Beam Therapy for Chordoma Patients

Phase II Evaluation of Proton Beam Therapy for Skull Base Chordoma

Recurrence classified as "central," "in-field", "marginal," "peripheral," or "distant" depending upon its relationship to the dose distribution on the original treatment plan.

MRI (or CT in case MRI is contraindicated) of the skull base used to document the status of disease in the following categories: 1) stable disease, 2) progressive disease, 3) partial response/complete response. A post-operative MRI (or CT) obtained within 90 days of study registration serves as baseline with annual follow up till disease progression or death for any reason.

M.D. Anderson Cancer Center

Symptoms and General Pathology

Hypoxia

Fluoroazomycin arabinoside

Radiopharmaceuticals

In residual chordoma tumors after surgery, Investigators propose a protontherapy guided by conventional imaging (CT/MRI) and a boost guided by FAZA PET/CT, in order to target the hypoxic zones and to increase the dose in an adequate manner, which could result in improving long-term local control and reducing complications.

The operative approach and operating time will be performed according to neurosurgical practices (for head and neck) or surgical orthopaedic team (for sacrum) depending on the location, the extension and the relationship of the lesion to critical structures.

The surgery can be macroscopically complete or incomplete.

Surgery

Radiotherapy will be done with the Cyclotron, for a total dose of 78 Gray Relative Biological Effective (Gy RBE) - 70 Gy RBE to the tumor bed and macroscopic volume and 8 Gy RBE to the the hypoxic component volume, delivered in 39 fractions spread over 67 days.

Protontherapy

FAZA PET/CT, in order to target the hypoxic zones

18F FAZA

Hamid MAMMAR, MD

Improved local control of chordoma initially treated with surgery or not, thanks to adjuvant radiotherapy oriented by conventional imaging Computed Tomography /Magnetic Resonance Imaging (CT / MRI) and guided by the \[18Fluor\] (\[18F\]) Fluoroazomycin Arabinofuranoside (FAZA) Positron Emission Tomography / Computed Tomography (PET / CT) to target the radioresistant hypoxic cells.

Due to the close contacts of the lesion with the neurovascular structures, in the case of skull base chordoma and mobile spine, surgery is often incomplete. On the contrary, surgery of the sacral region (for which the block excision is often possible) brings a better therapeutic outcome. Radiotherapy with high-dose supplement improves the outcomes for all these lesions.

Intratumoral hypoxia is a primary factor of radioresistance, it's known since long by radiation oncologists. \[18F\]FAZA gives an image of the hypoxic volume target. Investigators propose to increase the radioactive dose in the hypoxic volume target but in order to succeed, radiation oncologists have to precisely identify this hypoxic volume. Radiation oncologists would increase of 10% the radioactive dose that will allow us to improve local control at 3 years of 15% without any additional side effect.

Improvement of Local Control in Skull Base, Spine and Sacral Chordomas Treated by Surgery and Protontherapy Targeting Hypoxic Cells Revealed by [18F]FAZA) PET/CT Tracers

Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accordance with Institut Curie policies.

Institut Curie

Prospective non-invasive MRI acquisitions are planned to be performed

patients treated for skull base chordoma with particle therapy

Diffusion MRI sequences will be optimized to derive more accurate estimates of microstructure and microvasculature of tumour and healthy organs: multiple b-values will be acquired and advanced diffusivity models considered. MRI sequences to derive tumour hypoxia (i.e. indicative of radioresistance) will be also considered along with MR spectroscopy to evaluate tumour microenvironment.

diffusion MRI sequences

Alberto Iannalfi, MD

Cristina Bono, MSc

The study consists in the retrospective and prospective collection of imaging data (along with clinical information related to treatment) of skull-base chordoma patients treated with particle therapy, to derive imaging biomarkers which, integrated with advanced mathematical models, will allow predicting treatment outcome on a multi-scale basis.

The study design consists of the retrospective collection of routinely-acquired data (CT, MRI and dose maps, along with relevant clinical information) and the prospective acquisition of optimized non-invasive MR imaging data, of skull-based chordoma patients treated with particle therapy (PT) at the National Center for Oncological Hadrontherapy (CNAO, Pavia, Italy).

This data will be stored in a proper repository under CNAO's control, shared with Politecnico di Milano through encrypted channels, and it will be used to implement mathematical models able to predict treatment outcome at different scales (macroscopic, microscopic and radiobiological).

Multi-parametric Imaging in Personalized Radiotherapy

A Technical Framework for Combining Multi-parametric Imaging With Advanced Modelling in Personalized Radiotherapy

The prospective part of the study aims to collect data from MRI acquisition. It is not focused on patients treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Proton Beam Therapy for Chordoma Patients	NCT00496119	Chordoma	Proton Beam The... Photon Beam The...	-	M.D. Anderson Cancer Center
Improvement of Local Control in Skull Base, Spine and Sacral Chordomas Treated by Surgery and Protontherapy Targeting Hypoxic Cells Revealed by [18F]FAZA) PET/CT Tracers	NCT02802969	Skull Base Chor... Vertebral Chord...	Surgery Protontherapy 18F FAZA	18 Years -	Institut Curie
Multi-parametric Imaging in Personalized Radiotherapy	NCT05888064	Skull Base Chor...	diffusion MRI s...	18 Years -	CNAO National Center of Oncological Hadrontherapy
Improvement of Local Control in Skull Base, Spine and Sacral Chordomas Treated by Surgery and Protontherapy Targeting Hypoxic Cells Revealed by [18F]FAZA) PET/CT Tracers	NCT02802969	Skull Base Chor... Vertebral Chord...	Surgery Protontherapy 18F FAZA	18 Years -	Institut Curie
Improvement of Local Control in Skull Base, Spine and Sacral Chordomas Treated by Surgery and Protontherapy Targeting Hypoxic Cells Revealed by [18F]FAZA) PET/CT Tracers	NCT02802969	Skull Base Chor... Vertebral Chord...	Surgery Protontherapy 18F FAZA	18 Years -	Institut Curie

Spots Global Cancer Trial Database for skull base chordoma