Nanoparticles and Hypofractionated Protontherapy for Reirradiation of Pantumor Relapse (NANOPRO)

Centre Francois Baclesse

Status and phase

Withdrawn

Phase 2

Conditions

Recurrent Cancer

Previous Radiation

Treatments

Radiation: Radiation by protontherapy associated to nanoparticles injection

Study type

Interventional

Funder types

Other

Identifiers

NCT04784221

2020-003671-17

Details and patient eligibility

About

This is a prospective multicenter non-randomized phase II study: proton therapy with nanoparticles based on polysiloxane and gadolinium chelates injectable intravenously

Full description

This is a prospective multicenter non-randomized phase II study: proton therapy with nanoparticles based on polysiloxane and gadolinium chelates injectable intravenously in recurrent tumors

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient aged 18 or over
Patient with tumor of the cephalo-spino-iliosacral axis corresponding to the spectrum of tumors treated in protontherapy, particularly base of the skull, pharyngeal wall, parapharyngeal and retropharyngeal lymph nodes, cavum without associated lymph node, pre-spinal tumor, etc. tumors are immobile as opposed to visceral thoracic, abdominal and pelvic tumors which may be mobile which will be excluded because they cannot be irradiated in proton therapy in the current state of the art),
Tumor already irradiated, within more than 6 months before inclusion
Patient with a relapse or a new tumor in irradiated territory
Tumor considered to be radioresistant (TCD50> 50Gy)
Dosimetry (s) of previous irradiations available
Progressive tumor in tissue already irradiated to at least 40 Gy EQD2 (α / β = 2)
Indication of reirradiation by protontherapy for curative purposes. The indication for reirradiation by protontherapy will be discussed depending on the size and location of the tumor (particularlyfor a volume of less than or equal to 113 ml of PTV in an ENT situation may be taken into account), the presence of previous toxicities. It will be validated by RCP at the Center François Baclesse
The patient may have received previous systemic treatment
Evaluable disease according to RECIST 1.1 criteria
Performance Status ≤ 2
Normal renal function: creatinine clearance ≥ 50 ml / min
Patient affiliated to a social security system
Patient having given written consent

Exclusion criteria

Mobile tumors
Lymphomas, brain tumors (gliomas), meningiomas, skin carcinomas, malignant melanomas (skin or mucous membranes), tumor of the larynx, mobile lesions of the oral cavity
Recurrence occurring within 6 months of the end of the first irradiation
Patient with a contraindication to radiotherapy
Patient with progressive visceral or cerebral metastases
Life-threatening comorbidities within two years
Patient with a contraindication to MRI
Immovable metallic material in the target volume (significant imaging artefacts)
Impossibility of completely immobilizing the target volume (moving organ)
Large volume to be irradiated (PTV) for an acceptable benefit / risk balance evaluated in RCP of the François Baclesse Center
Neoplasic skin ulceration
Doses previously received by OARs or radiation toxicity already present preventing reirradiation including in protontherapy (clinical and dosimetric study of each case)
Concomitant cancer treatment such as chemotherapy, immunotherapy, targeted therapy or other, underway or planned to be initiated during irradiation
Simultaneous participation in another therapeutic clinical trial
Patient deprived of liberty, under guardianship or curatorship
Pregnant or breastfeeding patient
Patient unable to undergo medical monitoring of the trial for geographic, social or psychopathological reasons
History of other malignant disease in the past 3 years, except skin cancer other than melanoma, carcinoma in situ of the cervix. Any other solid tumor or lymphoma (without bone marrow involvement) must have been treated and not show signs of recurrence for at least 3 years