Actively Recruiting
Lymphocyte Support to SBRT in Patients With Oligo-metastatic Solid Cancer
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2025-12-01
58
Participants Needed
2
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lymphocyte Support to SBRT in Patients With Oligo-metastatic Solid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male or female patients aged 18 years or older
- Histologically or cytologically confirmed solid cancer at the oligometastatic stage with 1 to 5 active tumor lesions between 1 and 5 cm in size
- Disease may be genuinely oligometastatic, oligoprogressive, or induced oligometastatic
- All active lesions must be eligible for SBRT in terms of location and radiation constraints
- SBRT to all active lesions must be feasible within two weeks
- Patients must agree to biopsy and blood sample collection for research purposes
- Minimal wash-out periods from last treatments before starting SBRT: chemotherapy, immunotherapy, targeted therapy, hormone therapy, or investigational agents must be more than 4 weeks; immunosuppressive medications more than 4 weeks (with exceptions for certain corticosteroids); live attenuated vaccination more than 4 weeks; major surgery more than 4 weeks
- WHO performance status 0-1 and ECOG performance status 0-1
- Adequate organ function including specified blood counts, liver enzymes, and kidney function
- Female patients must be non-reproductive or have a negative pregnancy test before starting treatment and agree to contraception requirements
- Patients must provide informed consent and be able to comply with study procedures
- Patients must be affiliated with a social security system or equivalent
You will not qualify if you...
- Rapidly progressing disease at screening as determined by imaging and investigator judgment
- Presence of brain metastases
- Need to re-irradiate a previously treated tumor site
- Bone metastasis in femur with high fracture risk
- Liver metastases adjacent to stomach or small bowel or leaving less than 700 cc of uninvolved liver
- Severe or uncontrolled medical conditions (grade 3 or higher) that could affect study participation
- Psychiatric or social conditions limiting compliance or consent ability
- Active secondary malignancy expected to interfere with safety evaluation, except certain skin or cervical cancers or prior malignancies disease-free for 2 years
- Chronic systemic corticosteroid or immunosuppressant use above specified doses
- Tumors invading major blood vessels
- Central lung metastases within 2 cm of hilum that are cavitary
- Significant ongoing toxicities from prior treatments (grade 2 or higher) except alopecia and defined lab values
- Known allergy to study drug or its components including soy or peanuts
- Positive HIV test or AIDS diagnosis
- Risk factors for QT prolongation including baseline ECG abnormalities or low potassium
- Pregnant or breastfeeding women
- Persons deprived of freedom or under guardianship or unable to comply due to geographic, social, or psychological reasons
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Centre Léon Bérard
Lyon, France, 69000
Not Yet Recruiting
2
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
Research Team
L
Lisa SCHMIDT, MSc
CONTACT
D
Daphné MOREL, PharmD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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