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Trial Title:
A Study to Assess the Ability of Stereotactic Radiotherapy to Restore the Efficacy of Immunotherapy in Patients With Metastatic Cancer.
NCT ID:
NCT06363773
Condition:
Metastatic Cancer
Conditions: Official terms:
Neoplasm Metastasis
Conditions: Keywords:
stereotactic radiotherapy
immunotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Pilot, exploratory, prospective, monocentric study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Stereotactic Radiotherapy
Description:
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).
Arm group label:
Stereotactic radiotherapy
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female, 18 years of age or older,
2. Patient with a metastatic solid tumor,
3. Patient with at least one target lesion (for radiotherapy) together with other
secondary lesions that must be measurable,
4. Measurable disease according to RECIST 1.1 and iRECIST criteria,
5. Patient undergoing anti-PD1 immunotherapy as part of standard of care treatment,
6. Disease progression with immunotherapy (progression assessed by iRECIST criteria)
but having received at least 6 months of immunotherapy,
7. Performance Status (PS) of 0 or 1,
8. Patient eligible for stereotactic radiotherapy,
9. Patient affiliated to or benefiting from a social security scheme,
10. Patient having been informed of the investigation and having signed the informed
consent form prior to any study-specific procedures,
11. Patient willing and able to undergo all examinations and procedures in accordance
with the clinical investigation plan.
Exclusion Criteria:
1. Patient having received previous radiotherapy since the start of immunotherapy,
2. Patient for whom first disease progression (pre-inclusion stage) is not confirmed
secondarily (inclusion stage),
3. Patient with an active implantable medical device (e.g. pacemaker) or an active
medical device worn on the body that could interact adversely with stereotactic
radiotherapy treatment,
4. Patient with hematological cancer,
5. Symptomatic patient requiring a rapid change of systemic line according to the
investigator's judgment,
6. Concurrent participation in another clinical trial, or patient having received an
investigational product within 30 days prior to inclusion,
7. Pregnant or breast-feeding women,
8. Patient under legal protection.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Clinical
Address:
City:
Soyaux
Zip:
16800
Country:
France
Start date:
January 2025
Completion date:
January 2027
Lead sponsor:
Agency:
Elsan
Agency class:
Other
Source:
Elsan
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06363773
