Oligometastatic solid cancer
Conditions
Brief summary
Part I: safety Dose-limiting toxicity (DLT) is defined as an adverse event reported during the first three weeks of treatment that is possibly related to study intervention and fulfills any one of the following criteria using CTCAE Version 5.0: (...)Part II: efficacy on lymphoprotection The primary evaluation criterion is the rate of patients with lymphopenia grade ≥ 2 at 6 weeks after treatment completion, defined as an absolute lymphocyte count < 800/mm3 (CTCAE V5.0).
Detailed description
Secondary endpoints include: - Duration and grading of lymphopenia over time; - Overall safety; - Treatment compliance, rate and reasons of discontinuation; -Overall Survival; -Progression Free Survival, Exploratory endpoints include (and may not be limited to): s immunomonitoring - Characterization of the i- Circulating T cellmmune infiltrate before/during treatment using immunohistochemistry and RNA-sequencing of tumor lesions, respectively on FFPE and freshly frozen biopsies (in-field and out of the radiation field) - Biological dosimetry on circulating lymphocytes (as in Gruel G et al., Rad Res 2013) -(...)
Interventions
DRUGVESANOID 10 mg
DRUGcapsule molle
Sponsors
Institut Gustave Roussy, Institut Gustave Roussy
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part I: safety Dose-limiting toxicity (DLT) is defined as an adverse event reported during the first three weeks of treatment that is possibly related to study intervention and fulfills any one of the following criteria using CTCAE Version 5.0: (...)Part II: efficacy on lymphoprotection The primary evaluation criterion is the rate of patients with lymphopenia grade ≥ 2 at 6 weeks after treatment completion, defined as an absolute lymphocyte count < 800/mm3 (CTCAE V5.0). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include: - Duration and grading of lymphopenia over time; - Overall safety; - Treatment compliance, rate and reasons of discontinuation; -Overall Survival; -Progression Free Survival, Exploratory endpoints include (and may not be limited to): s immunomonitoring - Characterization of the i- Circulating T cellmmune infiltrate before/during treatment using immunohistochemistry and RNA-sequencing of tumor lesions, respectively on FFPE and freshly frozen biopsies (in-field and out of the radiation field) - Biological dosimetry on circulating lymphocytes (as in Gruel G et al., Rad Res 2013) -(...) | — |
Countries
France
Outcome results
None listed