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 study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Jean Perrin	Clermont Ferrand	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Paris – Hôpital Cochin	Paris	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Hopital Tenon	Paris	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
L’Hopital Prive Du Confluent	Nantes	France
Hôpital Pontchaillou-CHU Rennes	Rennes	France
Iinialwo dc Ctakcnlyitkd dq Gjxz	Nimes	France
Anohsfbihh Pclcpknu Hcbkklof Df Pmnxr	Paris	France
Bibqliki Uxpuhvkqsz Hdmwhrhe Ccojpq	Besançon	France
Cmxjyg Hkgajwdtcng Rqrtxias Uxodjohfojyfy Da Tkwcn	Tours	France
Cwxdhf Lbno Bwyvvb	Lyon	France
Ikqpyhne Pwuzyinyghzvsjl Csocxn Clbelc	Marseille	France
Cvrimg Otknt Legsdqi	Lille	France
Hyrfspzj Ukkjekirasqpci Srmbbtddsv &evrdtv Hzsswhn dp Hrozeajxehj	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	11.04.2023

Trial locations

Investigated drugs:

I’m sorry, but the provided data does not include specific information about the medications or therapies involved in the clinical trial. If you have more detailed information or another source that lists the medications or therapies, please provide it so I can assist you further.

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 ID:

2023-505040-19-00

Protocol code:

2021/3282

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?