anoparticle reirradiation and hypofractionated protontherapy of pan-tumor relapse: non-randomized phase II study.

Phase 1

• Conditions: recurrent tumors; MedDRA version: 20.0Level: PTClassification code 10038111Term: Recurrent cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-003671-17-FR
• Lead Sponsor: Centre François Baclesse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-05
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 51

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>- Progression-free survival in the reirradiation field and outside the reirradiation field<br>- The quality of life of patients<br>- Survival without degradation of the quality of life<br>- Overall survival<br>- 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