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
This trial does not accept healthy volunteersQualifiers
[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
Design model
Parallel
Treatments tested in this trial
all-trans retinoic acid
Drugper os treatment, started from the same day as SBRT, during 3 successive days, every 3 weeks, for a maximum of 4 cycles
Stereotactic Body Radiation Therapy
RadiationStandard of Care, planned over 1 or 2 weeks, every lesions must be irradiated
Treatment groups
58 Participants
are divided into 3 treatment groupsGroup A: Part I : Stereotactic Body Radiation Therapy + All-trans retinoic acidExperimental treatment 2 interventions
Group B: Part II : Stereotactic Body Radiation Therapy + All-trans retinoic acidExperimental treatment 2 interventions
Group C: Part II : Stereotactic Body Radiation Therapy alonePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting toxicities (DLT)
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
Time frame
from the first intake to 3 weeks after the treatment initiation2
Lympho-protective efficacy
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))
Time frame
At 6 weeks after SBRT completionSecondary outcomes
1
Control rates
Control rates on the treated lesions
Time frame
from 6 weeks to 1 year after SBRT2
Objective response rate
Objective response rate
Time frame
from 6 weeks to 1 year after SBRT3
Duration of response
Duration of response
Time frame
from 6 weeks to 1 year after SBRT4
Progression-free survival
Progression-free survival
Time frame
from 6 weeks to 1 year after SBRTSponsors and contacts
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Source ClinicalTrials.gov