Nanoparticle-Proton combo for recurrent cancer trial pulled before start
NCT ID NCT04784221
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study aimed to test whether combining special nanoparticles with proton radiation could help control cancers that return after previous radiation treatment. The trial was planned for adults with tumors in specific areas like the skull base or throat. However, the study was withdrawn before any patients were enrolled, so no data was collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AGuIX® nanoparticles
- What this could lead to
- If successful, this approach could offer a new way to treat cancers that return after previous radiation therapy.
- What could go wrong
- This trial was withdrawn before enrolling any participants, so no results are available. The combination is experimental and may not prove effective or safe.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Expected to start
-
Mar 2021
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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