Back to results

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 (PROTONCHORDE01)

Primary Purpose

Skull Base Chordoma, Vertebral Chordoma

Status

Active

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Surgery

Protontherapy

18F FAZA

About this trial

This is an interventional treatment trial for Skull Base Chordoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Typical chordoma and chondroid chordoma of the skull base, spine or chordoma of sacral region
Patient undergoing an additional or exclusive radiotherapy (Photontherapy and/or Prothontherapy)
Age ≥ 18 years old
ECOG performance status 0 to 2
Satisfying biological functions 28 days before inclusion :
1. Haemoglobin ≥ 9 g/dL
2. Neutrophils ≥ 1500/mm3
3. Platelets ≥ 100 000/mm3
4. ASAT, ALAT, GGT, PAL ≤ 1.5 N, bilirubin ≤ 40 μmol/L, LDH ≤ 1.5 N
5. Creatininemia < 1.5 N
Satisfying vital cardiac and respiratory functions
Neurologic functions well stabilised
Effective contraception for women of childbearing age during the the protontherapy treatment and during the month following the end of treatment. A pregnancy test shall be negative at inclusion.
Patient covered by health insurance
Patient provided with information and signature of informed consent.

Exclusion Criteria:

Dedifferentiated chordomas, chondrosarcoma
History of cancer (except cutaneous basocellular epithelioma or epithelioma of the uterine cervix) having recurred in the 5 years preceding entry in the trial and no relapse in the last 3 years
Metastatic patient
History of brain radiation therapy, or base of the skull or spinal segments to be treated
Contraindications to radiotherapy
Contraindications to PET/CT examinations [18F] Fluorodexoxyglucose (FDG) and [18]FAZA
Associated pathology likely to prevent the patient from receiving treatment,
Incompatible treatment with the inclusion in the study (oxygen therapy, EPO, anti-vascular treatments, anti-angiogenic treatments)
Patient already included in another therapeutic trial with an experimental medication,
Patient currently nursing,
Persons deprived of their liberty, or under guardianship,
Impossibility of undergoing the trial's medical follow-up for geographical, social or psychological reasons.

Sites / Locations

Institut Curie - Hôpital René Huguenin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[18F]FAZA PET/CT

Arm Description

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.

Outcomes

Primary Outcome Measures

Improvement local control of chordomas according to RECIST criteria.

Rate of local control at 3 years

Improvement local control of chordomas according to PERCIST criteria

Rate of local control at 3 years

Secondary Outcome Measures

Full Information

NCT ID

NCT02802969

First Posted

June 3, 2016

Last Updated

October 11, 2023

Sponsor

Institut Curie

1. Study Identification

Unique Protocol Identification Number

NCT02802969

Brief Title

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

Acronym

PROTONCHORDE01

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 22, 2016 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Curie

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skull Base Chordoma, Vertebral Chordoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

[18F]FAZA PET/CT

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Surgery

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

Protontherapy

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

18F FAZA

Other Intervention Name(s)

18F FLUOROAZOMYCIN-ARABINOFURANOSIDE

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement local control of chordomas according to RECIST criteria.

Description

Rate of local control at 3 years

Time Frame

36 months

Title

Improvement local control of chordomas according to PERCIST criteria

Description

Rate of local control at 3 years

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Typical chordoma and chondroid chordoma of the skull base, spine or chordoma of sacral region Patient undergoing an additional or exclusive radiotherapy (Photontherapy and/or Prothontherapy) Age ≥ 18 years old ECOG performance status 0 to 2 Satisfying biological functions 28 days before inclusion : Haemoglobin ≥ 9 g/dL Neutrophils ≥ 1500/mm3 Platelets ≥ 100 000/mm3 ASAT, ALAT, GGT, PAL ≤ 1.5 N, bilirubin ≤ 40 μmol/L, LDH ≤ 1.5 N Creatininemia < 1.5 N Satisfying vital cardiac and respiratory functions Neurologic functions well stabilised Effective contraception for women of childbearing age during the the protontherapy treatment and during the month following the end of treatment. A pregnancy test shall be negative at inclusion. Patient covered by health insurance Patient provided with information and signature of informed consent. Exclusion Criteria: Dedifferentiated chordomas, chondrosarcoma History of cancer (except cutaneous basocellular epithelioma or epithelioma of the uterine cervix) having recurred in the 5 years preceding entry in the trial and no relapse in the last 3 years Metastatic patient History of brain radiation therapy, or base of the skull or spinal segments to be treated Contraindications to radiotherapy Contraindications to PET/CT examinations [18F] Fluorodexoxyglucose (FDG) and [18]FAZA Associated pathology likely to prevent the patient from receiving treatment, Incompatible treatment with the inclusion in the study (oxygen therapy, EPO, anti-vascular treatments, anti-angiogenic treatments) Patient already included in another therapeutic trial with an experimental medication, Patient currently nursing, Persons deprived of their liberty, or under guardianship, Impossibility of undergoing the trial's medical follow-up for geographical, social or psychological reasons.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hamid MAMMAR, MD

Organizational Affiliation

Institut Curie

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Curie - Hôpital René Huguenin

City

Saint-Cloud

State/Province

Ile De France

ZIP/Postal Code

92210

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs