Lymphocyte Support to SBRT in Patients With Oligo-metastatic Solid Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGustave Roussy, Cancer Campus, Grand Paris
About this trial
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.
Eligibility criteria
Qualifiers
[1-5] active tumor lesions with a largest diameter comprised between [1-5] cm,
The disease can be either genuinely oligometastatic, oligoprogressive, or an induced oligometastatic disease
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 largest diameter on CT-scan, and/or any new lesion of ≥ 1cm on the most recent CT-scan
SBRT to all active lesions must be feasible over a two-week period,
Disqualifiers
None
Trial design
Treatments tested in this trial
- all-trans retinoic acid
- Stereotactic Body Radiation Therapy
Treatment groups
58 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov