Actively Recruiting
Pan-lesions SBRT Combined With Lymphocyte Support Through ATRA-driven Blockade of MDSC 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
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with oligo-metastatic solid cancer to assess the safety of combining stereotactic body radiation therapy (SBRT) directed at all metastatic lesions with all-trans retinoic acid (ATRA). This phase I/II clinical trial aims to evaluate whether ATRA can protect lymphocytes from radiation-induced damage, which may improve immune response and control of cancer spread. The study is conducted in two parts: an initial safety evaluation followed by a randomized comparison of SBRT alone versus SBRT combined with ATRA. The treatment involves delivering SBRT to all tumor lesions larger than 1.5 cm on weekdays over a maximum of two weeks. In the experimental arms, patients receive oral ATRA at 150 mg/m2/day for three days every three weeks, for up to four cycles starting with the first day of radiation. Part I of the study includes six patients receiving the combination to assess safety. Part II randomizes 52 patients equally to SBRT with or without ATRA to evaluate ATRA's ability to reduce lymphopenia, a reduction in lymphocyte count caused by radiation. Participants will undergo blood tests, biopsies, and imaging scans for monitoring safety, treatment response, and lymphocyte levels. The primary outcomes are dose-limiting toxicities assessed up to three weeks after treatment start, and lymphocyte protection measured six weeks after SBRT. Secondary outcomes include tumor control rates, response rates, duration of response, and progression-free survival tracked from six weeks to one year post-treatment. Participants are expected to comply with follow-up visits, blood sampling, and biopsies during the study period.
CONDITIONS
Brief 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 18 years of age or older
- Histologically or cytologically proven solid cancer at the oligometastatic stage with 1 to 5 active tumor lesions between 1 and 5 cm
- All active tumor lesions must be eligible for SBRT based on location and radiotherapy constraints
- SBRT must be feasible to deliver to all active lesions within two weeks
- Patients must agree to comply with biopsy and blood sampling for research purposes
- Minimum wash-out period of more than 4 weeks from prior systemic chemotherapy, immunotherapy, targeted therapy, hormone therapy, immunosuppressive medication, live attenuated vaccination, or major surgery
- WHO performance status 0-1 and ECOG performance status 0-1
- Adequate organ function including white blood cell count ≥ 1,500/mm3, lymphocyte count ≥ 800/mm3, platelet count ≥ 100,000/mm3, hemoglobin > 9 g/dL, liver enzymes within specified limits, and creatinine clearance > 40 mL/min
- Female patients must be non-reproductive or have a negative pregnancy test prior to starting ATRA and agree to use effective contraception if of childbearing potential
- Patients must be able and willing to comply with study visits and procedures
- Patients must be affiliated to a social security system or beneficiary of the same
You will not qualify if you...
- Evidence of rapidly progressing disease at screening
- Presence of brain metastases
- Need for re-irradiation of previously treated tumor sites
- Bone metastasis in femoral bone with high risk of fracture
- Liver metastasis close to stomach or small bowel or with insufficient uninvolved liver volume
- Severe or uncontrolled medical conditions that may affect study participation
- Psychiatric illness or social situations limiting compliance or informed consent
- Active secondary malignancy unless not interfering with safety evaluation
- Chronic systemic corticosteroid or immunosuppressant treatment exceeding allowed doses
- Tumors invading major blood vessels
- Central lung metastasis near hilum that are cavitary
- Persistent significant toxicities from prior treatments
- Allergy to study drug or soy/peanut allergy
- HIV positive or AIDS diagnosis
- Risk factors for QT prolongation
- Pregnant or breastfeeding women
- Persons deprived of freedom or under guardianship preventing study follow-up requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants receive stereotactic body radiation therapy (SBRT) to all eligible tumor lesions over 1 or 2 weeks. Those in the experimental arms also take all-trans retinoic acid (ATRA) orally for 3 days every 3 weeks for up to 4 cycles, starting the same day as SBRT.
Weekly visits for up to 4 cycles
Duration - 6 weeks to 1 year
Participants are monitored for treatment outcomes and safety, including control rates, response, and progression-free survival, from 6 weeks up to 1 year after SBRT completion.
Visits at 6 weeks and periodically up to 1 year
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
D
Daphné MOREL, PharmD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here