At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Best Practice (other), Biopsy Procedure (procedure), Biospecimen Collection (procedure), Bleomycin Sulfate (biological)
- How long the study runs
- Study runs about 121 months (dates as stated)
- About the drug or intervention
- Best Practice — other: Undergo observation · Biopsy Procedure — procedure: Undergo a tumor biopsy · Biospecimen Collection — procedure: Undergo blood sample collection · Bleomycin Sulfate — biological: Given IV · Carboplatin — drug: Given IV · Cisplatin — drug: Given IV · Computed Tomography — procedure: Undergo a CT scan · Etoposide — drug: Given IV · Magnetic Resonance Imaging — procedure: Undergo MRI · Pulmonary Function Test — procedure: Undergo a pulmonary function test · Questionnaire Administration — other: Ancillary studies
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by the Children's Oncology Group, looks at care for children, teenagers and young adults with germ cell tumours outside the brain. It compares active monitoring (called active surveillance) with chemotherapy drugs — bleomycin, etoposide, carboplatin or cisplatin — depending on how advanced the tumour is.
Who can take part
- Newly diagnosed germ cell tumour outside the brain, confirmed by tissue testing, with a few rare exceptions (for example, very high tumour markers when a biopsy is not in the patient's best interest)
- Low-risk group: any age, with stage I tumours (ovarian immature teratoma, or stage I malignant germ cell tumours of the ovary, testicle or elsewhere outside the brain)
- Standard-risk group 1: under 11 years old with stage II or higher malignant germ cell tumour
- Standard-risk group 2: aged 11 to under 25 with stage II or higher malignant germ cell tumour meeting certain risk rules
- For those having chemotherapy: adequate kidney, liver and blood counts, and fit enough for the treatment; not pregnant or breastfeeding, and agreeing to use contraception if sexually active
Who may not be able to
- Tumours not listed in the study, including tumours in the brain, pure dysgerminoma or seminoma outside the testicle, pure mature teratoma, and 'poor risk' disease
- Stage I testicular cancer already treated with surgery to remove lymph nodes in the abdomen (retroperitoneal lymph node dissection)
- Any prior drug treatment (systemic therapy) for this cancer, or prior radiotherapy (except radiotherapy to brain metastases for standard-risk 1 patients)
- Significant existing lung disease that makes bleomycin unsafe, for the standard-risk groups
- Pure immature teratoma with alpha-fetoprotein (a tumour marker) of 1,000 ng/mL or more
- Germ cell tumour with certain rare changes (somatic malignant transformation) or spermatocytic seminoma
What taking part involves
- • Active surveillance — close monitoring without immediate treatment (low-risk groups)
- • Chemotherapy with bleomycin, etoposide and carboplatin or cisplatin (standard-risk groups)
Time commitment: Not stated — ask the trial team about number of visits, duration and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- Not specified
- Who
- All
- Number of participants
- 1,780
- Started
- 2017-05-25
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for childhood extracranial germ cell tumor
- • Phase3 - 1,780 participants
- • This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed
Who can take part?
- • Adults
- • Diagnosed with childhood extracranial germ cell tumor
Where?
- • Broomhall - Sheffield Children's Hospital
- • Cambridge - Addenbrookes Hospital-Medical School
- • London - Saint Bartholomew's Hospital
- • London - University College London Hospitals NHS Trust - Foley Street
- • +11 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.
More detail
PRIMARY OBJECTIVES: I. To evaluate whether a strategy of complete surgical resection followed by surveillance can maintain an overall survival rate of at least 95.7% at two years for pediatric, adolescent and adult patients with stage I (low risk) malignant germ cell tumors (Stratum 2), and at least 88% for patients with all stage/grade ovarian pure immature teratoma (Stratum 1). II. To compare the event-free survival of a carboplatin versus (vs.) cisplatin-based regimen in the treatment of pediatric, adolescent and young adult patients with standard risk non-seminomatous germ cell tumors. IIa. To compare the event free survival (EFS) of a carboplatin-based regimen (carboplatin \[C\] etoposide \[E\] bleomycin \[b\]) vs. a cisplatin-based regimen (cisplatin \[P\]Eb) in children (less than 11 years in age) with standard risk germ cell tumors (GCT). IIb. To compare the EFS of a carboplatin-based regimen (BEC) vs. a cisplatin-based regimen (BEP) in adolescents and young adults (ages 11 - \< 25 years) with standard risk GCT. SECONDARY OBJECTIVES: I. To compare the incidence of ototoxicity in children, adolescents and young adults with standard risk germ cell tumors treated with carboplatin-based chemotherapy as compared to cisplatin-based chemotherapy. II. To refine and validate a novel patient-reported measure of hearing outcomes for children, adolescents and young adults with standard risk germ cell tumors. III. To determine whether radiomic measures of body composition at diagnosis, end of therapy, and one year after end of therapy is better correlated with adverse events compared to body surface area in patients receiving chemotherapy for germ cell tumors. EXPLORATORY OBJECTIVES: I. To prospectively determine the correlation of tumor marker decline (alpha-fetoprotein \[FP\] and beta-human chorionic gonadotropin \[HCG\]) with clinical outcome in low and standard risk germ cell tumor patients. II. To compare self-reported peripheral neuropathy and other patient-reported outcomes between children, adolescents and young adults with standard risk germ cell tumors treated with carboplatin-based chemotherapy as compared to cisplatin-based chemotherapy. III. Assess the relationship between hearing loss as measured by audiometry with the effects of tinnitus as assessed on the Adolescent and Young Adult Hearing Screening (AYA-HEARS) instrument. IV. To evaluate the prognostic significance of serum micro ribonucleic acid (miRNA)s in stage I seminoma patients by collecting clinical data and serum specimens for future analysis. V. To compare differences in the proportion of patients with residual mass(es) ≥ 1 cm at the completion of chemotherapy among patients randomized to the cisplatin and carboplatin-containing arms and to compare the proportion undergoing post-chemotherapy surgery for residual mass(es), and the proportion of resected masses with viable malignancy, teratoma, or necrosis. VI. To investigate whether there is an association between serum miRNAs measured immediately post-operatively and time-to-relapse in stage I non-seminomatous germ cell tumor patients and to estimate the trajectory of miRNA over time. OUTLINE: Patients with low-risk stage I grade 2, 3 ovarian immature teratoma or stage I non-seminoma malignant germ cell tumors (MGCT)s undergo observation and can transfer to standard risk arm at time of recurrence if eligibility criteria are met. Patients with stage I seminoma testicular MGCT undergo observation, and those with residual/recurrent disease are treated at the discretion of their physician. Patients undergo computed tomography (CT), magnetic resonance imaging (MRI), and/or chest x-ray as well as blood sample collection throughout the trial to monitor for response and recurrence. Patients may also undergo a tumor biopsy throughout the trial. Patients with standard risk 1 are randomized into 1 of 2 arms. ARM I (CEb): Patients receive bleomycin intravenously (IV) over 10 minutes and carboplatin IV over 1 hour on day 1. Patients also receive etoposide IV over 1-2 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study. ARM II (PEb): Patients receive bleomycin IV over 10 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study. Patients with standard risk 2 are randomized into 1 of 2 arms. ARM III (BEC): Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study. ARM IV (BEP): Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study. After completion of study treatment, patients are followed up every 2 months for 12 months, every 3-6 months to 24 months, every 6 months for years 3-5, and then annually for up to 10 years.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: Not specified
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ of all patients at enrollment , with the following exceptions:
Treatments you must NOT have had:
- ✗ systemic
- ✗ radiation
What the study is looking for
- ✓There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or...
- ✓Standard risk 1: Patients must be \< 11 years of age at enrollment
- ✓Standard risk 2: Patients must be \>= 11 and \< 25 years of age at enrollment
- ✓Histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is...
- ✓Standard risk 2 (SR2)
Who cannot take part
- ✗Patients with any diagnoses not listed including:
- ✗Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)
- ✗Pure ovarian or extragonadal dysgerminoma/seminoma
- ✗Pure mature teratoma
- ✗Pure immature teratoma with alpha-fetoprotein (AFP) \>= 1000 ng/mL
See the full criteria
Where Is This Study? (15 UK sites)
Sheffield Children's Hospital
Broomhall S10 2TH, United Kingdom
Addenbrookes Hospital-Medical School
Cambridge CB2 0QQ, United Kingdom
Saint Bartholomew's Hospital
London EC1A 7BE, United Kingdom
University College London Hospitals NHS Trust - Foley Street
London W1W 6DN, United Kingdom
Royal Manchester Children Hospital
Manchester M27 4HA, United Kingdom
Royal Victoria Infirmary
Newcastle NE1 4LP, United Kingdom
Freeman Hospital
Newcastle upon Tyne NE7 7DN, United Kingdom
John Radcliffe Hospital
Oxford OX3 9DU, United Kingdom
Weston Park Hospital
Sheffield S10 2SJ, United Kingdom
Saint James's University Hospital
West Yorkshire LS9 7TF, United Kingdom
Western General Hospital
Edinburgh EH4 2XU, United Kingdom
Royal Hospital for Children and Young People
Edinburgh EH9 1LF, United Kingdom
Beatson Oncology Center
Glasgow G12 0YN, United Kingdom
Royal Hospital for Children
Glasgow G51 4TF, United Kingdom
Leeds General Infirmary
West Yorkshire LS1 3EX, United Kingdom
