Centre Clinical
Soyaux, Charente, 16800, France
Location status: Recruiting
NCT Number: NCT06363773
This study aims at enrolling patients with solid tumors at metastatic stage, considered long responders to immunotherapy (> 6 months) and displaying disease progression.
In this study, the investigator wants to evaluate specific modalities of stereotactic radiotherapy, with 3 sessions, each of 8 Gy, lasting 20 minutes and spaced 72 hours apart (Day 1, Day 4, Day 7). The radiotherapy device itself is not the subject of this study and will be used in accordance with its CE mark and indications.
The objective of the study is to assess the ability of stereotactic radiotherapy to restore the lost efficacy of immunotherapy. In particular, the abscopal effect will be assessed, i.e. the action of irradiating a particular target lesion and observing an effect on other distant metastases.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Soyaux, Charente, 16800, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will perform stereotactic radiotherapy with 3 sessions (8 Gy) during 20 minutes each and with 72 hours in-between.
Patients enrolled in the study would not have received this stereotactic radiotherapy outside the study, that is why this procedure is additional (compared to Standard of care) and considered as burdensome (as this is radiation). Before performing the stereotactic radiotherapy, patients will do a radiotherapy CT scanner (no injected) in order to prepare precisely the radiotherapy (treatment plan).
Time frame: At 3 months after stereotactic radiotherapy
Assessment of Objective Response Rate (Complete Response and Partial Response with iRECIST criteria) according to a centralised independent reading.
Time frame: At 3 months after stereotactic radiotherapy
Assessment of Objective Response Rate (Complete Response and Partial Response with RECIST 1.1 criteria) according to a centralised independent reading.
Time frame: Up to 12 months after stereotactic radiotherapy
Time frame: Up to 12 months after stereotactic radiotherapy
Time frame: Up to 12 months after stereotactic radiotherapy
Duration (in days) before introduction of a new systemic treatment.
Time frame: Up to 12 months after stereotactic radiotherapy
Collection of adverse events (AEs) up to 12 months after radiotherapy.
Time frame: Up to 12 months after stereotactic radiotherapy
Time frame: Up to 12 months after stereotactic radiotherapy
Time frame: Up to 12 months after stereotactic radiotherapy
Time frame: Up to 12 months after stereotactic radiotherapy
Time frame: Up to 12 months after stereotactic radiotherapy
Time frame: Up to 12 months after stereotactic radiotherapy
Time frame: Up to 12 months after stereotactic radiotherapy
Time frame: Up to 12 months after stereotactic radiotherapy
Contact information is provided by the study sponsor or research team.
Elsan
Other
Pilot, Exploratory, Prospective Study to Assess the Ability of Stereotactic Radiotherapy to Restore the Efficacy of Anti-PD1 Immunotherapy in Initially Long-responder Patients With Metastatic Progression.
Acronym: RESTO-IMMUNO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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