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RecruitingPHASE3INTERVENTIONAL

Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors

This research trial is for children and adults with a type of cancer called germ cell tumours. The study has two main parts. One part is for people with lower-risk tumours that have been removed by surgery. Doctors want to see if simply watching closely over time (called 'active surveillance') is a safe and effective way to manage these tumours, rather than more aggressive treatment. The other part of the study compares two different chemotherapy treatments, using drugs like carboplatin or cisplatin, for people with more advanced tumours. Researchers want to find out which chemotherapy works better for preventing the cancer from coming back and which causes fewer side effects like hearing problems.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Children's Oncology Group
Enrolment target
1,780
Start
25 May 2017
Estimated completion
30 Jun 2027
Childhood Extracranial Germ Cell TumorExtragonadal Embryonal CarcinomaGerm Cell TumorMalignant Germ Cell TumorMalignant Ovarian TeratomaStage I Ovarian ChoriocarcinomaStage I Ovarian Embryonal Carcinoma AJCC v6 and v7Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7Stage I Testicular Choriocarcinoma AJCC v6 and v7Stage I Testicular Embryonal Carcinoma AJCC v6 and v7Stage I Testicular Seminoma AJCC v6 and v7Stage I Testicular Yolk Sac Tumor AJCC v6 and v7Stage II Ovarian ChoriocarcinomaStage II Ovarian Embryonal Carcinoma AJCC v6 and v7Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7Stage II Testicular Choriocarcinoma AJCC v6 and v7Stage II Testicular Embryonal Carcinoma AJCC v6 and v7Stage II Testicular Yolk Sac Tumor AJCC v6 and v7Stage III Ovarian ChoriocarcinomaStage III Ovarian Embryonal Carcinoma AJCC v6 and v7Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7Stage III Testicular Choriocarcinoma AJCC v6 and v7Stage III Testicular Embryonal Carcinoma AJCC v6 and v7Stage III Testicular Yolk Sac Tumor AJCC v6 and v7Stage IV Ovarian ChoriocarcinomaStage IV Ovarian Embryonal Carcinoma AJCC v6 and v7Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7Testicular Mixed Choriocarcinoma and Embryonal CarcinomaTesticular Mixed Choriocarcinoma and TeratomaTesticular Mixed Choriocarcinoma and Yolk Sac Tumor

What is this study about?

This study is looking into the best ways to care for children and adults who have been diagnosed with germ cell tumours. These tumours can be found in different parts of the body.

There are two main goals for this research. The first goal is for people with early-stage, lower-risk germ cell tumours that have been removed by surgery. The doctors want to find out if simply monitoring these patients carefully over time – a method called 'active surveillance' – is just as effective and safe as giving further treatment. This means regularly checking for any signs that the tumour might be coming back, without immediately using strong medications.

The second goal of the study is for patients with germ cell tumours that have spread a bit further. For these patients, the study compares two common chemotherapy treatments. Chemotherapy uses powerful medicines to kill cancer cells or stop them from growing. Researchers want to see if a treatment using carboplatin is better or worse than a treatment using cisplatin. They will look at how well each treatment stops the cancer from returning and which one causes fewer side effects, especially hearing problems.

Key takeaways

  • This study is about treatments for germ cell tumours in children and adults.
  • It checks if simply watching (active surveillance) is safe after surgery for low-risk tumours.
  • It compares two chemotherapy treatments (carboplatin vs. cisplatin) for more advanced tumours.
  • Researchers want to find the best treatment that has fewer side effects, especially hearing problems.
  • The study involves regular check-ups, scans, and sometimes questionnaires.

Who may be eligible?

This study is open to both children and adults who have been diagnosed with a germ cell tumour.

For some parts of the study, you must have a newly diagnosed, early-stage tumour that has been fully removed by surgery. For other parts of the study, it's for newly diagnosed patients with germ cell tumours that are a bit more advanced.

Your doctors will need to confirm the exact type of germ cell tumour you have. In some rare cases, if a biopsy isn't possible or delays treatment, you might still be able to join based on very high tumour marker levels and imaging scans.

Quick self-check
  • Have I been diagnosed with a germ cell tumour?
  • Is my tumour newly diagnosed?
  • Has my tumour been fully removed by surgery (for the 'watching' part of the study)?
  • Have my doctors confirmed the exact type and stage of my germ cell tumour?
  • Am I under 25, or any age for certain low-risk tumours?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, what you do will depend on which part of the trial you're in. If you're in the 'active surveillance' group, you'll have regular check-ups, scans like CT or MRI, and possibly blood tests to monitor your health and ensure the tumour doesn't return. If you're in the chemotherapy group, you'll receive specific chemotherapy drugs, either carboplatin-based or cisplatin-based, likely through infusions. You'll also have regular tests, scans, and blood work to monitor your health and the treatment’s effects. You may also be asked to complete questionnaires about how you're feeling and potentially have hearing tests. The total duration of your participation will depend on your specific treatment plan and follow-up schedule, but it will involve continued monitoring for some time after initial treatment.

Potential risks and benefits

Taking part in this study could offer several potential benefits, such as receiving close medical attention for your condition and access to potentially new or refined treatment approaches. For those receiving chemotherapy, it could help determine which drugs are most effective with fewer side effects. However, there are potential risks, including side effects from the chemotherapy drugs like hearing problems, or the stress of frequent monitoring if you're on active surveillance. It's important to remember that you are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (629)

  • Children's Hospital of Alabama
    Birmingham, United States· Recruiting
  • USA Health Strada Patient Care Center
    Mobile, United States· Suspended
  • Anchorage Associates in Radiation Medicine
    Anchorage, United States· Recruiting
  • Anchorage Radiation Therapy Center
    Anchorage, United States· Suspended
  • Alaska Breast Care and Surgery LLC
    Anchorage, United States· Recruiting
  • Alaska Oncology and Hematology LLC
    Anchorage, United States· Recruiting
  • Alaska Women's Cancer Care
    Anchorage, United States· Recruiting
  • Anchorage Oncology Centre
    Anchorage, United States· Suspended
  • Katmai Oncology Group
    Anchorage, United States· Recruiting
  • Providence Alaska Medical Center
    Anchorage, United States· Recruiting
  • Kingman Regional Medical Center
    Kingman, United States· Recruiting
  • Banner Children's at Desert
    Mesa, United States· Recruiting

+617 more sites — see the official record for the full list.

Common questions

What is a germ cell tumour?

Germ cell tumours are a type of cancer that starts in cells that would normally develop into sperm or eggs, but can also be found in other parts of the body.

What does 'active surveillance' mean?

Active surveillance means that after surgery, doctors closely watch your condition with regular check-ups and scans, instead of giving more immediate treatment like chemotherapy.

What is chemotherapy?

Chemotherapy uses strong medicines to kill cancer cells or stop them from growing. In this study, they are looking at specific drugs like carboplatin and cisplatin.

Why are they comparing carboplatin and cisplatin?

The study wants to find out which of these chemotherapy drugs works better against the cancer and causes fewer side effects, especially hearing problems.

Will my age affect whether I can join?

This study includes both children and adults. Your specific age and the stage of your tumour will determine which part of the study might be suitable for you.

How to find out more

Official trial record

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 "Active Surveillance, Bleomycin, Etoposide, Carboplatin or Ci…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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