recurrent tumors MedDRA version: 20.0 Level: PT Classification code 10038111 Term: Recurrent cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Gadolinium-chelated polysiloxane nanoparticles
Product Code: AGuIX®
Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion
INN or Proposed INN: AGuIX
Current S
Sponsors
Centre François Baclesse
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient with tumor of the cephalo-spino-iliosacral axis corresponding to the spectrum of tumors treated in proton therapy, in particular base of the skull, pharyngeal wall, parapharyngeal and retropharyngeal lymph nodes, cavum without associated lymph node, pre-spinal tumor, etc. (sites where the tumors are immobile unlike visceral thoracic, abdominal and pelvic tumors which may be mobile which will be excluded because they cannot be irradiated in proton therapy) - 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 - Tumor evolving into tissue already irradiated to at least 40 Gy EQD2 (a / ß = 2) - indication of curativef re-irradiation by proton-therapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 51 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 51
Exclusion criteria
Exclusion criteria: - Mobile tumors - Lymphomas, brain tumors (gliomas), meningiomas, skin carcinomas, Malignant melanomas (skin or mucous membranes),laryngeal tumor, mobile lesions of the oral cavity - Recurrence occurring less than 6 months from the end of the prior irradiation - Patient with a contraindication to radiotherapy - Patient with progressive visceral or cerebral metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the local efficacy of a treatment combining the administration of nanoparticles with proton therapy delivered according to a hypofractionated regimen in patients with a relapse of a radiation-resistant tumor in already irradiated territory.;Secondary Objective: - The tolerance profile - Progression-free survival in the reirradiation field and outside the reirradiation field - The quality of life of patients - Survival without degradation of the quality of life - Overall survival - The complete or partial response rate at one year (according to the TCP definition);Primary end point(s): The local progression-free survival rate at 2 years, defined by the proportion of patients alive and without local progression two years after the start of proton therapy according to RECIST 1.1 criteria;Timepoint(s) of evaluation of this end point: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Acute and late toxicities assessed according to NCI CTCAE v. 5.0 in terms of types of toxicities, grade, time to onset and reversibility. - Progression-free survival at 2 years, defined by the time between the start of treatment and the date of tumor progression (according to RECIST 1.1 criteria) or death from whatever cause - Quality of life score, according to the standardized QLQ-C30 quality of life questionnaire - Survival without degradation of the quality of life defined by the time between the start of treatment and death whatever the cause or a deterioration in the quality of life defined by a reduction of more than 10 points in the quality score of overall life of the QLQ-C30 questionnaire - Overall survival defined by the time between the start of treatment and the date of death regardless of the cause - Proportion of patients with a complete or partial response one year after the end of proton therapy, according to the TCP definition;Timepoint(s) of evaluation of this end point: up to progressive disease | — |
Countries
France
Contacts
Public ContactLECONTE Alexandra
Centre François Baclesse
Outcome results
None listed