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Study on Improving Treatment for Young Adults with Poor-Prognosis Non-Seminomatous Germ-Cell Tumors Using Paclitaxel and Drug Combination

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What is this trial about?

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

This clinical trial focuses on improving outcomes for young adults with a type of cancer known as non-seminomatous germ-cell tumors. These tumors can originate in areas such as the testis, retroperitoneal (the area behind the abdominal cavity), and mediastinal (the area in the chest between the lungs) and are considered to have a poor prognosis when they have spread to other parts of the body. The study aims to evaluate the effectiveness and safety of a personalized treatment approach based on early assessment of tumor markers, which are substances in the body that can indicate the presence of cancer.

The treatment involves several medications, including paclitaxel, Mesna, Etoposide, Cisplatin, Lenograstim, Oxaliplatin, Ifosfamide, Carboplatin, and bleomycin. These medications are administered through infusions or injections, and their use is tailored to each patient's needs. The study also includes the use of a placebo to compare the effects of the actual medications. The trial will monitor the progression of the disease and the overall survival of the participants, as well as any side effects experienced during the treatment.

Participants will undergo regular assessments to track their response to the treatment, including the use of MRI scans to check for any spread of the cancer to the brain. The study will also evaluate the quality of life of the participants using specific questionnaires. The goal is to provide a comprehensive understanding of how these treatments can improve the health and well-being of patients with this challenging type of cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the clinical trial, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Blood tests and imaging studies may be performed to establish a baseline for the trial.

  2. Step 2

    Treatment cycle 1

    The first treatment cycle begins with the administration of medications through IV infusion or injection. These medications include mesna, paclitaxel, etoposide, cisplatin, oxaliplatin, ifosfamide, carboplatin, and bleomycin sulfate.

    The medication lenograstim is administered through a subcutaneous injection to support blood cell production.

    The duration and frequency of each medication are determined by the trial protocol and are closely monitored by the medical team.

  3. Step 3

    Monitoring and assessment

    Throughout the treatment cycle, regular monitoring is conducted to assess the response to the medications. This includes blood tests and imaging studies.

    The effectiveness of the treatment is evaluated by measuring tumor markers and observing any changes in tumor size.

  4. Step 4

    Treatment cycle 2

    A second cycle of treatment is administered, following the same protocol as the first cycle. Adjustments may be made based on the response observed in the initial cycle.

    Continued monitoring ensures that any side effects are managed promptly.

  5. Step 5

    Final assessment

    At the end of the treatment cycles, a comprehensive assessment is conducted to evaluate the overall response to the treatment.

    This includes a review of all test results and imaging studies to determine the progression-free survival and overall survival.

  6. Step 6

    Follow-up

    After completing the treatment, regular follow-up visits are scheduled to monitor long-term outcomes and manage any ongoing side effects.

    Patients are encouraged to report any new symptoms or concerns during these follow-up visits.

Who can join the trial?

13 criteria

  • Male patient older than 16 years old on the day of signing the informed consent.
  • Patient must be affiliated with a social security system or be a beneficiary of the same.
  • Male of child-bearing potential must agree to use two methods of medically acceptable forms of contraception during the study and for 6 months after the last treatment intake. This means using one method for the patient and one for the partner.
  • Patient (and his legal guardian if under 18) must have understood, signed, and dated the informed consent form.
  • Patient must have evidence of NSGCT (Non-seminomatous germ-cell tumors) based on a tissue examination or clinical evidence with elevated serum hCG (a hormone) or AFP (a protein) levels. In emergencies, treatment can start before a tissue sample is obtained if these markers are very high.
  • Patient must have a primary tumor site in the testicular, retroperitoneal (area behind the abdominal organs), or mediastinal (area in the chest) regions.
  • Patient must have evidence of disseminated disease, which means the cancer has spread to other parts of the body, classified as clinical stages II or III.
  • Patient's disease must be classified as poor prognosis according to specific criteria, which include:
    • Primary mediastinal NSGCT
    • Non-pulmonary visceral metastases (cancer spread to organs other than the lungs)
    • hCG levels greater than 50,000 UI/L, or AFP levels greater than 10,000 ng/mL, or LDH (an enzyme) levels greater than 10 times the upper normal value
    • Patient must have adequate renal function (kidney function), with a creatinine clearance greater than 60 mL/min. This is a measure of how well the kidneys are working.
    • Patient must have an absolute granulocyte count (a type of white blood cell) of at least 1,500/mm3, platelets (cells that help with blood clotting) of at least 100,000/mm3, and bilirubin (a substance made by the liver) no more than 1.5 times the upper limit of normal value.
    • Patients who cannot undergo a brain MRI are eligible, but they will not be part of the diagnostic study part.

Who cannot join the trial?

6 criteria

  • Patients who are not diagnosed with non-seminomatous germ-cell tumors. These are a type of cancer that can occur in the testis, retroperitoneal (area behind the abdominal organs), or mediastinal (area in the chest between the lungs).
  • Patients whose disease is not in a disseminated stage. This means the cancer has not spread beyond its original location.
  • Patients who do not have a poor prognosis according to specific medical criteria. A poor prognosis means that the expected outcome or chance of recovery is not favorable.
  • Patients who are not young adults. The study is focused on a specific age group.
  • Patients who are female. The study is only for male participants.
  • Patients who belong to a vulnerable population. This refers to groups of people who may be at a higher risk of harm or exploitation.
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Investigated drugs

  • Paclitaxel

    is a chemotherapy medicine given as a drip (infusion) into a vein. It works by freezing the internal scaffolding that cancer cells need in order to divide, which stops the tumour cells from multiplying and causes them to die. In this trial it is part of the intensified chemotherapy combinations used to treat young adults with aggressive germ-cell tumours.

  • Cisplatin

    is one of the most important chemotherapy medicines for germ-cell tumours and is given as an infusion into a vein. It attaches to the DNA inside cancer cells and damages it so badly that the cells can no longer copy themselves and die. It forms the backbone of the standard treatment that all patients in this trial receive.

  • Etoposide

    is a chemotherapy medicine given through a vein that blocks an enzyme cancer cells use to untangle their DNA when they divide. Without this enzyme the DNA breaks and the cancer cells die. It is given together with cisplatin and bleomycin as part of the standard combination for germ-cell tumours.

  • Bleomycin

    is a chemotherapy medicine given by injection or infusion into a vein. It works by cutting the DNA strands inside cancer cells, which stops them from growing. It is a long-established part of the standard three-drug combination used for testicular and other germ-cell cancers.

  • Ifosfamide

    is a chemotherapy medicine given as an infusion into a vein. It damages the genetic material of cancer cells so they cannot divide, and it is often used in stronger combinations for patients whose germ-cell tumour responds poorly to the first treatment. In this trial it is part of the intensified chemotherapy given when early blood-marker tests suggest the standard treatment may not be enough.

  • Mesna

    is not a cancer treatment itself but a protective medicine given into a vein together with ifosfamide. It binds to the irritating breakdown products of ifosfamide in the urine and so protects the bladder from inflammation and bleeding during chemotherapy.

What is already known about the treatment

  • Paclitaxel

    Paclitaxel is a chemotherapy medicine given as an infusion into a vein, originally derived from the bark of the Pacific yew tree. It is one of the most widely used anticancer drugs and is standard treatment for breast, ovarian and lung cancers, and it is also used in germ-cell tumours. It works by binding to the microtubules inside cells and freezing them in place, so dividing cancer cells cannot separate their chromosomes and die. It belongs to the group of taxanes.

  • Cisplatin

    Cisplatin is a platinum-based chemotherapy medicine administered as an intravenous infusion. It is the backbone of curative treatment for testicular and other germ-cell tumours and has transformed the outlook of these cancers since the 1970s. The platinum atom binds to the DNA of cancer cells and creates cross-links that block the copying of genetic material, which stops cell division and triggers cell death. It is classified as a platinum compound with an alkylating-like action.

  • Etoposide

    Etoposide is a chemotherapy medicine given as an infusion into a vein and a standard partner of cisplatin and bleomycin in the treatment of germ-cell tumours. It is also widely used in lung cancer and blood cancers. It blocks the enzyme topoisomerase II, which cells need to untangle their DNA during division; the resulting DNA breaks kill rapidly dividing tumour cells. It belongs to the topoisomerase inhibitors derived from the plant substance podophyllotoxin.

  • Bleomycin

    Bleomycin is a chemotherapy medicine given as an injection or infusion into a vein and is a classic component of the BEP regimen for testicular and other germ-cell tumours. It is also used in Hodgkin lymphoma. It acts like molecular scissors: it binds iron and oxygen and uses them to cut the DNA strands of cancer cells, which prevents the cells from multiplying. It is classified as a cytotoxic antibiotic.

  • Ifosfamide

    Ifosfamide is a chemotherapy medicine administered as an intravenous infusion and commonly used in germ-cell tumours, sarcomas and several childhood cancers. It is a well-established drug that is activated in the liver. As an alkylating agent it attaches chemical groups to the DNA of rapidly dividing cells, damaging it so the cells can no longer divide. Because its breakdown products can irritate the bladder, it is always combined with the protective medicine mesna.

  • Carboplatin

    Carboplatin is a platinum-based chemotherapy medicine given as an infusion into a vein. It was developed as a better-tolerated relative of cisplatin and is widely used in ovarian, lung and germ-cell cancers, particularly when high-dose treatment is needed. Like cisplatin, it forms cross-links in the DNA of tumour cells, blocking DNA copying and forcing the cells into programmed death. It belongs to the group of platinum compounds.

Investigated diseases

Non-seminomatous germ-cell tumors – These tumors originate from germ cells and can occur in the testis, retroperitoneal, or mediastinal areas. They are characterized by a mix of different cell types, including embryonal carcinoma, yolk sac tumor, choriocarcinoma, and teratoma. The disease often presents with a disseminated form, meaning it has spread beyond its original site. Progression involves an increase in tumor size and potential spread to other organs, such as the lungs or liver. Tumor markers in the blood, such as alpha-fetoprotein (AFP) and human chorionic gonadotropin (hCG), may rise as the disease progresses. Radiographic imaging may show growth or new lesions, indicating further advancement of the disease.
Trial detailsLast updated 22 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505040-19-00Protocol code2021/3282Estimated enrolment150 patientsSponsorInstitut Gustave Roussy

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