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Study on Adjuvant Treatment for Unilateral Retinoblastoma with Vincristine Sulfate and Drug Combination in Patients After Primary Eye Removal

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 eye cancer called Retinoblastoma, which primarily affects young children. The study is specifically looking at cases where the cancer is present in one eye and has been treated by removing the affected eye, a procedure known as primary enucleation. The purpose of the study is to understand how well additional treatments, known as adjuvant treatments, work in preventing the cancer from coming back. These treatments are given after the surgery to address any remaining cancer risk factors identified through examining the removed tissue.

The study involves several medications that are used as part of the adjuvant treatment. These include ONCOVIN (vincristine sulfate), THIOTEPA (found in both THIOTEPA GENOPHARM and TEPADINA), ENDOXAN (cyclophosphamide), ETOPOSIDE TEVA (etoposide), and CARBOPLATINE TEVA (carboplatin). These medications are administered through injections or infusions, which are methods of delivering the drugs directly into the bloodstream or body. Some patients may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual drugs.

Participants in the study will receive these treatments and be monitored over time to see if the cancer returns and to evaluate any side effects from the treatments. The study will also look at the long-term effects of the treatments and how they impact the patients' overall health. Additionally, researchers will study the genetic makeup of the tumors and use imaging techniques like MRI to detect any spread of the cancer beyond the eye. The study aims to provide valuable information that could improve treatment strategies for children with retinoblastoma in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is required to have a diagnosis of non-familial extensive unilateral retinoblastoma that has been treated by primary enucleation. The patient must be between 2 months and 10 years old.

    The patient must not have received chemotherapy or radiotherapy prior to the study treatment. Adequate organ function is necessary, including hematopoietic, hepatic, and renal functions, as well as normal audiometry and echocardiography results.

  2. Step 2

    Treatment initiation

    The treatment begins with the administration of vincristine sulfate as a solution for injection. This medication is given intravenously.

    The patient will also receive thiotepa for intrathecal use, which involves administering the medication into the spinal canal.

  3. Step 3

    Chemotherapy regimen

    The chemotherapy regimen includes cyclophosphamide, etoposide, and carboplatin. These medications are administered intravenously.

    The specific dosages and frequency of administration will be determined by the medical team based on the patient's condition and response to treatment.

  4. Step 4

    Monitoring and follow-up

    Throughout the treatment, the patient will be monitored for any side effects or complications. Regular follow-up appointments will be scheduled to assess the patient's response to the treatment.

    The primary goal is to determine the disease-free survival (DFS) for patients treated with this regimen.

  5. Step 5

    Evaluation of outcomes

    The study aims to evaluate the rate of extraocular relapses and assess both long-term and acute toxicities of the treatment.

    Additional evaluations include the frequency of different histopathological risk factors and the sensitivity of MRI in detecting extraocular extension.

Who can join the trial?

13 criteria

  • The patient must be a boy or girl who is at least 2 months old but younger than 10 years at the time of signing the consent form.
  • The patient must have a diagnosis of a type of eye cancer called **non-familial extensive unilateral retinoblastoma** that has been treated by removing the affected eye.
  • The patient must not have received any chemotherapy (cancer treatment with drugs) or radiotherapy (cancer treatment with radiation) before starting the study treatment for retinoblastoma or any other type of tumor.
  • The patient must not have any medical reasons that would prevent them from taking the study drugs.
  • The patient must be able to be followed up for a long time after the treatment.
  • A written informed consent must be signed, and if appropriate for the patient's age, an assent (agreement) will also be obtained according to the rules of the institution.
  • The patient must be part of a Social Security Regimen or be a beneficiary of it.
  • If the patient needs chemotherapy after surgery, they must have adequate organ function, which includes:
  • **Adequate hematopoietic function**: This means having enough white blood cells called neutrophils and enough platelets, which help with blood clotting.
  • **Adequate hepatic function**: The liver must be working well, as measured by specific medical standards.
  • **Adequate renal function**: The kidneys must be working well, with normal levels of a waste product called creatinine in the blood, adjusted for the patient's age.
  • **Audiometry**: Hearing tests must show results below a certain level of hearing loss.
  • **Echocardiography**: An ultrasound of the heart must be normal if the patient is receiving a high dose of a chemotherapy drug called cyclophosphamide.

Who cannot join the trial?

6 criteria

  • Patients with medical conditions other than retinoblastoma cannot participate. Retinoblastoma is a type of eye cancer that usually affects young children.
  • Patients who have not undergone primary enucleation are excluded. Primary enucleation is a surgical procedure to remove the eye.
  • Patients who do not require adjuvant treatment are excluded. Adjuvant treatment is additional therapy given after the main treatment to lower the risk of the cancer coming back.
  • Patients with bilateral retinoblastoma are excluded. Bilateral retinoblastoma means the cancer is present in both eyes.
  • Patients with any other serious health conditions that could interfere with the study are excluded.
  • Patients who are unable to follow the study procedures or attend follow-up visits are excluded.
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Investigated drugs

RB SFCE 2009: This is a code name for a treatment being studied in patients with a type of eye cancer called unilateral retinoblastoma. The treatment is given after the affected eye is surgically removed. The goal is to see if this treatment can help prevent the cancer from coming back, based on certain risk factors seen under a microscope.

What is already known about the treatment

Carboplatin – Carboplatin is administered intravenously, typically as part of a chemotherapy regimen. It is currently used in medical practice and extensively documented in medical literature for its effectiveness in treating various cancers, including retinoblastoma. The main therapeutic indication for carboplatin is as a treatment for cancer, particularly when used as an adjuvant therapy following surgical procedures like enucleation in retinoblastoma. At the molecular level, carboplatin works by binding to DNA in cancer cells, causing cross-linking and ultimately leading to cell death. It is classified pharmacologically as a platinum-based chemotherapy agent.

Investigated diseases

Retinoblastoma – Retinoblastoma is a rare type of eye cancer that typically develops in early childhood, affecting the retina, which is the light-sensitive lining at the back of the eye. It usually occurs in one eye (unilateral) but can sometimes affect both eyes (bilateral). The disease begins when nerve cells in the retina develop genetic mutations, causing them to grow uncontrollably and form a tumor. As the tumor grows, it can cause symptoms such as a white color in the pupil, eye redness, or vision problems. If not addressed, the tumor can extend beyond the eye, potentially affecting nearby tissues. The progression of retinoblastoma can vary, with some cases remaining localized while others may spread to other parts of the body.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2024-514844-10-00Protocol codeIC 2009-04Estimated enrolment195 patientsSponsorInstitut Curie

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