Lymphocyte Support to SBRT in Patients With Oligo-metastatic Solid Cancer
Status:
RECRUITING
Trial end date:
2027-01-01
Target enrollment:
Participant gender:
Summary
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 1.5cm, 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.