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Reirradiation by Nanoparticles and Hypofractionated Protontherapy of Relapsed Tumors: Non-randomized Phase II Study. (NANOPRO)

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ClinicalTrials.gov Identifier: NCT04784221
Recruitment Status : Not yet recruiting
First Posted : March 5, 2021
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Francois Baclesse

Tracking Information
First Submitted Date  ICMJE March 2, 2021
First Posted Date  ICMJE March 5, 2021
Last Update Posted Date May 25, 2021
Estimated Study Start Date  ICMJE September 2021
Estimated Primary Completion Date September 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2021)
Local efficacy of a treatment combining the administration of nanoparticles with proton therapy [ Time Frame: 2 years after the treatment ]
proportion of patients alive and without local progression two years after the start of proton therapy (local progression-free survival rate)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reirradiation by Nanoparticles and Hypofractionated Protontherapy of Relapsed Tumors: Non-randomized Phase II Study.
Official Title  ICMJE Reirradiation by Nanoparticles and Hypofractionated Protontherapy of Relapsed Pan-tumors: Non-randomized Phase II Study.
Brief Summary This is a prospective multicenter non-randomized phase II study: proton therapy with nanoparticles based on polysiloxane and gadolinium chelates injectable intravenously
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Recurrent Cancer
  • Previous Radiation
Intervention  ICMJE 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

Study Arms  ICMJE Experimental: Radiation by protontherapy associated to nanoparticles injection
Intervention: Radiation: Radiation by protontherapy associated to nanoparticles injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 2, 2021)
46
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2026
Estimated Primary Completion Date September 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Delphine LEROUGE, MD 332455050 d.lerouge@baclesse.unicancer.fr
Contact: Jacques BALOSSO, Prof 332455050 j.balosso@baclesse.unicancer.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04784221
Other Study ID Numbers  ICMJE 2020-003671-17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Francois Baclesse
Study Sponsor  ICMJE Centre Francois Baclesse
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Francois Baclesse
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP