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Lymphocyte Support to SBRT in Patients With Oligo-metastatic Solid Cancer

NCT06439888 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-12-01

No results posted yet for this study

Summary

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

  • Oligometastatic Disease
  • Solid Tumor, Adult

Interventions

DRUG

all-trans retinoic acid

per os treatment, started from the same day as SBRT, during 3 successive days, every 3 weeks, for a maximum of 4 cycles

RADIATION

Stereotactic Body Radiation Therapy

Standard of Care, planned over 1 or 2 weeks, every lesions must be irradiated

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

  • Eric DEUTSCH, PhD, MD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-11
Primary Completion
2026-09-30
Completion
2027-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06439888 on ClinicalTrials.gov