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Pan-lesions SBRT Combined With Lymphocyte Support Through ATRA-driven Blockade of MDSC in Patients With Oligo-metastatic Solid Cancer (LySATRA)
The goal of this clinical trial is to assess safety of pan-metastases directed SBRT combined with ATRA and the lympho-protective efficacy of ATRA upon radiation-induced lymphopenia. This is a French bicentric, open label, phase I/II clinical study that will comprise two parts. Part I will evaluate the safety of the combination based on a single-arm safety run design, while Part II will be randomized (ratio 1:1) and will study SBRT with or without ATRA. Patients enrolled will be treated with: * SBRT to all lesions more than 1cm, on week days (from Monday to Friday), over a maximum of 2 weeks, * With or without (for part II patients randomized in the control arm) ATRA therapy: ATRA 150 mg/m\^2/day for 3 days every 3 weeks for a maximum of 4 cycles (about 3 months), starting on the first day of radiation therapy. The expected rate of patients who will have lymphopenia of grade 2 or higher in the control arm at 6 weeks post-radiotherapy is 50%. At a one-sided level of statistical significance of 0.07, the randomization of 52 patients (26 patients in each arm) will provide 85% power to detect a decrease in this rate to 15% in the SBRT+ATRA arm, using Fisher's exact test.
Details
| Lead sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | RECRUITING |
| Enrolment | 58 |
| Start date | 2024-07-11 |
| Completion | 2027-01 |
Conditions
- Oligometastatic Disease
- Solid Tumor, Adult
Interventions
- all-trans retinoic acid
- Stereotactic Body Radiation Therapy
Primary outcomes
- Dose-limiting toxicities (DLT) — from the first intake to 3 weeks after the treatment initiation
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 DLT criteria using CTCAE Version 5.0 - Lympho-protective efficacy — At 6 weeks after SBRT completion
Rate of patients with lymphopenia grade 2 or higher at 6 weeks after treatment completion (as absolute lymphocyte count less than 800/mm3 (CTCAE V5.0))
Countries
France