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New treatment option for Oligometastatic Disease
Official title Lymphocyte Support to SBRT in Patients With Oligo-metastatic Solid Cancer
ClinicalTrials.gov ID: NCT06439888
What this study is testing
What is all-trans retinoic acid?
all-trans retinoic acid is an investigational medicine, being studied as a potential treatment for oligometastatic disease.
Also referred to as Tretinoin, VESANOID.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- [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...
- SBRT to all active lesions must be feasible over a two-week period,
See the full eligibility 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...
- [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...
- SBRT to all active lesions must be feasible over a two-week period,
- Whatever the primary tumor type I3. Patients must agree to comply with biopsy and blood sampling for research purpose; I4. Minimal wash-out periods from last administration of treatments to the first day of SBRT must be:
- Systemic chemotherapy including cytotoxic, immunotherapy, targeted therapy, hormone therapy, any investigational agent \> 4 weeks,
- Immunosuppressive medication \> 4 weeks, with the exceptions of intranasal, topical, and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceeding 10 mg/day of prednisone, or...
- Live attenuated vaccination \> 4 weeks,
- Major surgery \> 4 weeks; I5. WHO 0-1 and ECOG Performance Status 0-1; I6. Patients must have adequate organ function defined as follows:
- White blood cell count of ≥ 1,500/mm3,
- Lymphocyte count of ≥ 800/mm3,
- Platelet count of ≥ 100,000/mm3,
- Hemoglobin \> 9 g/dL, Serum ALT and AST ≤2.5 ULN (or if liver metastases are present must be ≤ 5x ULN) f. Serum creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine...
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France; Villejuif, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.