Nanoparticles and Hypofractionated Protontherapy for Reirradiation of Pantumor Relapse

NCT04784221 | Withdrawn Phase 2

• 1 other identifier: 2020-003671-17
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Recurrent Cancer; Previous Radiation

Keywords

protontherapy; nanoparticles; AguIX

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Radiation by protontherapy associated to nanoparticles injection

EXPERIMENTAL

Radiation: Radiation by protontherapy associated to nanoparticles injection

Interventions

Radiation by protontherapy associated to nanoparticles injection RADIATION

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

Radiation by protontherapy associated to nanoparticles injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Francois Baclesse: lead

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: March 1, 2021
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share