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Study on the Safety and Efficacy of Tretinoin with Radiation Therapy for Patients with Oligometastatic Solid Cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as oligometastatic solid cancer. This is a stage of cancer where the disease has spread to a limited number of other parts of the body. The study will use a treatment called VESANOID, which contains the active substance tretinoin. Tretinoin is a chemical compound that is taken orally in the form of a soft capsule. The purpose of the study is to evaluate the safety and effectiveness of combining a special type of radiation therapy, called SBRT (Stereotactic Body Radiation Therapy), with tretinoin to support the immune system by blocking certain cells that can suppress immune responses.

The study will be conducted in two parts. In the first part, the focus will be on assessing the safety of using SBRT together with tretinoin. In the second part, the study will look at how well tretinoin can protect the immune system, particularly the lymphocytes, which are a type of white blood cell, from the effects of radiation. Participants will receive the treatment over a period of time, and their health and response to the treatment will be monitored closely. The study aims to understand if this combination can help manage the cancer more effectively while maintaining the health of the immune system.

Throughout the study, various aspects will be observed, such as the duration and severity of any decrease in lymphocytes, overall safety, and how well patients adhere to the treatment. The study will also track the control of cancer lesions and the overall survival of participants. This research hopes to provide valuable insights into improving treatment options for patients with oligometastatic solid cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's objectives and procedures. The patient must provide written consent to participate in the study.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history, physical examination, and necessary laboratory tests to ensure adequate organ function and overall health status.
Step 3
Treatment phase part I
The patient will receive pan-metastases directed stereotactic body radiation therapy (SBRT) combined with ATRA (tretinoin).
The medication, VESANOID 10 mg in soft capsule form, is administered orally. The dosage and frequency will be determined by the study protocol and the patient's specific condition.
Step 4
Monitoring and safety assessment
During the first three weeks of treatment, the patient will be closely monitored for any adverse events. This period is crucial for assessing the safety of the treatment combination.
Step 5
Treatment phase part II
The focus will shift to evaluating the lymphoprotective efficacy of ATRA in preventing radiation-induced lymphopenia. The patient will continue to receive the treatment as per the study protocol.
Step 6
Follow-up assessments
The patient will undergo regular follow-up assessments to monitor the duration and grading of lymphopenia, overall safety, and treatment compliance.
These assessments will occur at 6, 12, and 24 weeks, and 1 year after treatment completion.
Step 7
Final evaluation
The final evaluation will include an assessment of the patient's response to treatment, progression-free survival, and overall survival.
The study is estimated to conclude by September 30, 2026.

Who can join the trial?

10 criteria

Patients must be adults, meaning they are **18 years or older**.
Patients must have a type of cancer called **oligometastatic solid cancer**, which means the cancer has spread to a few places in the body.
The cancer must be suitable for a treatment called **SBRT** (a type of precise radiation therapy) and meet specific size and location requirements.
Patients must agree to have **biopsies** (small tissue samples taken) and **blood samples** collected for research purposes.
There must be a **minimum waiting period** from the last treatment to the start of SBRT, which is more than 4 weeks for chemotherapy, immunotherapy, certain medications, and major surgery.
Patients must have a **performance status** of 0-1, which means they are fully active or have some symptoms but can still do light work.
Patients must have **adequate organ function**, which includes specific levels of blood cells, liver enzymes, and kidney function.
Female patients must not be able to become pregnant or must have a **negative pregnancy test** before starting the study. Both men and women must agree to use **effective birth control** during the study and for a short time after.
Patients must **understand and sign a consent form** agreeing to participate in the study and follow the study procedures.
Patients must be part of a **social security system** or have similar benefits.

Who cannot join the trial?

4 criteria

Patients who have a different type of cancer than the one being studied, which is called oligometastatic solid cancer. This means the cancer has spread to a few other places in the body.
Patients who are not within the specified age range for the study.
Patients who are not part of the specific group of people the study is looking to include.
Patients who are considered part of a vulnerable population, which means they might need extra protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Centre Leon Berard
Lyon, France
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Centre Oscar Lambret
Lille, France
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Institut Gustave Roussy
Villejuif, France

Trial locations

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Investigated drugs

SBRT (Stereotactic Body Radiation Therapy)
is a type of radiation therapy that delivers high doses of radiation to tumors in the body with precision. It is used in this trial to target and treat metastatic cancer lesions, aiming to control or reduce the size of the tumors.
ATRA (All-Trans Retinoic Acid)
is a medication used in this trial to support the immune system by blocking certain cells that suppress immune function. It is combined with SBRT to potentially enhance the treatment's effectiveness and protect lymphocytes, which are important cells in the immune system, from being reduced by radiation therapy.

Tretinoin

What is already known about the treatment

ATRA – ATRA, or all-trans retinoic acid, is administered orally in the form of capsules. It is currently being studied in clinical trials for its potential use in treating oligometastatic solid cancer. The main therapeutic indication for ATRA in this context is to support lymphocyte function and block certain immune-suppressing cells during cancer treatment. At the molecular level, ATRA works by modulating gene expression, which can influence cell differentiation and proliferation. It is classified pharmacologically as a retinoid, which is a class of compounds related to vitamin A.

Investigated diseases

Oligometastatic Solid Cancer – Oligometastatic solid cancer is a stage of cancer where the disease has spread from the primary site to a limited number of other locations in the body, typically fewer than five. This condition is considered an intermediate state between localized cancer and widespread metastatic disease. The cancer cells in oligometastatic disease have the potential to grow and spread, but they are often confined to specific areas, making them potentially treatable with localized therapies. The progression of oligometastatic cancer can vary, with some cases remaining stable for extended periods, while others may progress to more widespread metastasis. Understanding the behavior of oligometastatic cancer is crucial for determining appropriate treatment strategies.