All studies
RecruitingPHASE2INTERVENTIONAL

Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma

This research study is for men diagnosed with seminoma, a form of testicular cancer. Doctors are investigating whether a particular scan, called a PET-TDM (Positron Emission Tomography-Time-of-Flight Mass Spectrometry), can guide them in choosing the most effective and perhaps less intensive treatment. The study aims to find out if using this scan helps more patients receive a lighter treatment plan for either early-stage or more advanced seminoma. The treatments being looked at include carboplatin, etoposide, and cisplatin, which are all types of chemotherapy. This is a Phase 2 study, meaning it's exploring how well these strategies work and looking at their safety.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Enrolment target
271
Start
01 Jun 2013
Estimated completion
01 Jun 2026

What is this study about?

This study is designed for men who have been diagnosed with seminoma, which is a type of cancer that develops in the testicles. The main goal of this research is to explore how a specific type of scan, called a PET-TDM, can help doctors make better decisions about treatment. Doctors want to see if using this scan can help them identify patients who might be able to have a less intense overall treatment plan. This could mean fewer side effects while still effectively treating the cancer.

Seminoma can be found at different stages. This study is looking at two main groups of patients: those with early-stage seminoma (known as Grade I), and those with seminoma that has spread a bit more, like to lymph nodes (known as metastatic seminoma). By using the PET-TDM scan, the researchers hope to get a clearer picture of the cancer's activity. This information can then help them decide if a person needs a strong course of treatment, or if a lighter approach might be just as effective.

The treatments mentioned in this study, carboplatin, etoposide, and cisplatin, are all chemotherapy drugs commonly used to treat seminoma. This study is in Phase 2, which means researchers are checking how well these strategies work with the scan guidance and also keeping a close eye on safety.

Key takeaways

  • This study uses a special scan (PET-TDM) to help tailor seminoma treatment.
  • It aims to see if some patients can have a lighter treatment plan.
  • It's for men diagnosed with either early-stage or more advanced seminoma.
  • Treatments include standard chemotherapy drugs like Carboplatin, Etoposide, or Cisplatin.
  • Knowing your cancer stage and general health are important for eligibility.
  • You can stop participating at any point if you wish.

Who may be eligible?

This study is for men who have been diagnosed with seminoma, a type of testicular cancer, that has been confirmed through a biopsy after surgery to remove the testicle (orchiectomy). The cancer must have started in the testicle or in the back of the abdomen (retroperitoneal area). Your blood tests for a marker called alpha-fetoprotein must be normal both before and after your surgery. You must not have had any previous radiotherapy or chemotherapy for your cancer. You need to be at least 18 years old, and generally in good health, meaning you can carry out most daily activities without problems. Your blood counts, liver, and kidney functions must be within certain healthy ranges.

There are also specific requirements depending on whether you have early-stage or more advanced seminoma. For those with early-stage seminoma, you must have what's called 'Grade I'. If your seminoma is more advanced, it needs to fit specific categories of spread, like size of lymph nodes in your abdomen or whether it has spread to areas above your diaphragm, as long as certain blood markers (LDH) aren't too high. For these more advanced cases, your PET-TDM scan must also show active cancer.

You would not be able to join if you have HIV, Hepatitis B or C, or if you've had another type of cancer in the last five years (except treated skin cancer). You also can't have cancer that has spread to your internal organs or brain. If you have serious or uncontrolled heart or liver problems, or if there's any reason your doctor feels the treatment might not be safe for you, you wouldn't be able to participate. You must also be able to understand the study and give your written permission to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you a man, 18 or older, diagnosed with seminoma?
  2. Has your seminoma been confirmed after testicle removal surgery?
  3. Do your doctors think your seminoma fits certain 'Grade I' or 'metastatic' categories?
  4. Have you not had radiotherapy or chemotherapy for seminoma before?
  5. Are your general health, blood counts, and organ functions within healthy ranges?
  6. Are you able to provide written permission (consent) to join the study?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a special scan called a PET-TDM. This scan will help your doctors decide on the best treatment plan for you, which could involve chemotherapy with drugs like Carboplatin, Etoposide, or Cisplatin. The exact schedule of your treatments and follow-up will depend on the stage of your seminoma and the treatment plan chosen based on the scan results. You will have regular appointments for check-ups, blood tests, and scans to monitor your health and how the treatment is working. The study team will explain how many visits you'll need and for how long you'll be followed up. The total duration of your involvement will be thoroughly explained to you before you agree to participate.

Potential risks and benefits

Taking part in this study may offer the potential benefit of a more personalised treatment plan based on detailed scan results, which for some, could lead to a less intense treatment course with potentially fewer side effects. However, like all medical treatments, there are potential risks associated with the chemotherapy drugs, such as nausea, hair loss, fatigue, and effects on blood counts, kidneys, or nerves, which your doctor will explain in detail. There's also the chance the treatment may not work for you, or you might experience side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Gustave Roussy
    Verified postcode
    Villejuif, France· Recruiting

Common questions

What is seminoma?

Seminoma is a common type of cancer that develops in the testicles.

What is a PET-TDM scan?

It's a special scan that helps doctors see where cancer cells are active in your body, providing detailed information to guide treatment.

What are Carboplatin, Etoposide, and Cisplatin?

These are common chemotherapy medicines used to treat cancer, including seminoma.

What does 'Phase 2' study mean?

It means the study is looking at how well a new strategy works and checking for side effects in a larger group of people after initial safety tests.

Can I choose not to have the scan?

The PET-TDM scan is a key part of this study's approach to guiding treatment decisions.

How to find out more

Yohann LORIOT, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Therapeutic Strategy Guided by PET-TDM for Patients With Sem…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.