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

Nanoparticles and Hypofractionated Protontherapy for Reirradiation of Pantumor Relapse: NANOPRO, a Non-randomized Phase II Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Recurrent Cancer; Previous Radiation
• Intervention / Treatment: Radiation: Radiation by protontherapy associated to nanoparticles injection

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Delphine LEROUGE, MD; Phone Number: 332455050; Email: d.lerouge@baclesse.unicancer.fr
• Study Contact Backup: Name: Jacques BALOSSO, Prof; Phone Number: 332455050; Email: j.balosso@baclesse.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiation by protontherapy associated to nanoparticles injection	Radiation: Radiation by protontherapy associated to nanoparticles injection; Treatment for the study will be based on proton therapy and the administration of AGuIX® nanoparticles. Protontherapy will be carried out for 4 consecutive weeks with 5 sessions per week (20 sessions) from D1 to D26. The administration of the AGuIX® nanoparticle will be done on Days 1, 8 and 15 during protontherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local efficacy of a treatment combining the administration of nanoparticles with proton therapy	proportion of patients alive and without local progression two years after the start of proton therapy (local progression-free survival rate)	2 years after the treatment

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: nanoparticles; protontherapy; AguIX
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: 2020-003671-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No