Recurrent CancerPhase 2NANOPRONCT04784221
Nanoparticles and Hypofractionated Protontherapy for Reirradiation of Pantumor Relapse
A Phase 2 study testing Radiation by protontherapy associated to nanoparticles injection in people with Recurrent Cancer and Previous Radiation, run by Centre Francois Baclesse.
Trial summary
This is a prospective multicenter non-randomized phase II study: proton therapy with nanoparticles based on polysiloxane and gadolinium chelates injectable intravenously Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Cancer, Previous Radiation
- What is being tested?
- Radiation by protontherapy associated to nanoparticles injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Sep 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
Official title: 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
Read the 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
- Conditions
- Recurrent Cancer, Previous Radiation
- Being tested
- Radiation by protontherapy associated to nanoparticles injection
- Keywords
- protontherapy, nanoparticles, AguIX
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation by protontherapy associated to nanoparticles injectionRadiation
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 group | Role | What they receive |
|---|---|---|
| Radiation by protontherapy associated to nanoparticles injection | Experimental | Not described Receives: Radiation: Radiation by protontherapy associated to nanoparticles injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 years after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study startMar 2021 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Why it stopped: Study prematurely terminated following the decision by industrial partner to withdraw from the project (product supply issue).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784221
- Sponsor's protocol ID
- 2020-003671-17
- Acronym
- NANOPRO
- Status last verified
- Sep 2025
- First submitted
- 2 Mar 2021
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanoparticles and Hypofractionated Protontherapy for Reirradiation of Pantumor Relapse: NANOPRO, a Non-randomized Phase II Study
- ClinicalTrials.gov ID
- NCT04784221
- Acronym / sponsor ID
- NANOPRO / 2020-003671-17
- Conditions
- Recurrent Cancer, Previous Radiation
- Keywords
- protontherapy, nanoparticles, AguIX
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study prematurely terminated following the decision by industrial partner to withdraw from the project (product supply issue).
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation by protontherapy associated to nanoparticles injection | Experimental | Radiation: Radiation by protontherapy associated to nanoparticles injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation by protontherapy associated to nanoparticles injectionTreatment 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 | Radiation by protontherapy associated to nanoparticles injection |
Primary outcome
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation by protontherapy associated to nanoparticles injection in people with Recurrent Cancer and Previous Radiation, run by Centre Francois Baclesse.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local efficacy of a treatment combining the administration of nanoparticles with proton therapy (time frame: 2 years after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.