Lymphocyte Support to SBRT in Patients With Oligo-metastatic Solid Cancer
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 com
| Condition(s) | Oligometastatic Disease, Solid Tumor, Adult |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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 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 |
| Who can participate | Inclusion Criteria: Participants are eligible for enrolment in the study only if ALL of the following criteria apply: I1. Adult male or female patients (≥ 18 years of age at inclusion); I2. Histologically or cytologically proven solid cancer at the oligometastatic stage and/or oligoprogressive amenable to pan-lesion SBRT, as defined by: 1. \[1-5\] active tumor lesions with a largest diameter comprised between \[1-5\] cm, 2. The disease can be either genuinely oligometastatic, oligoprogressive, or an induced oligometastatic disease 3. All active tumor lesions (progressive and/or hypermetabolic) that match criterion I2a must be eligible to SBRT in terms of location and radiotherapy constraints. 'Active lesion' is defined as either: hypermetabolic on PET-scan, recent increase of \>20% of its |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
| Locations | Lyon, France; Villejuif, France |
| Start date | 2024-07-11 |
| NCT ID | NCT06439888 |
| Official listing | https://clinicaltrials.gov/study/NCT06439888 |