Health Trials

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

ConditionsChildhood 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
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChildren's Oncology Group

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT [all sites])

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

Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with malignant germ cell tumor (stage II or higher).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Best Practice

    Other intervention

    Undergo observation

  • Biopsy Procedure

    Procedure/Surgery

    Undergo a tumor biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bleomycin Sulfate

    Biological/Vaccine

    Given IV

  • Carboplatin

    Drug

    Given IV

  • Cisplatin

    Drug

    Given IV

  • Computed Tomography

    Procedure/Surgery

    Undergo a CT scan

  • Etoposide

    Drug

    Given IV

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Pulmonary Function Test

    Procedure/Surgery

    Undergo a pulmonary function test

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

1,780 Participants
are divided into 5 treatment groups
Group A: Arm I (bleomycin, carboplatin, etoposide)Experimental treatment 9 interventions
Group B: Arm II (bleomycin, etoposide, cisplatin)Experimental treatment 9 interventions
Group C: Arm III (bleomycin, etoposide, carboplatin)Experimental treatment 9 interventions
Group D: Arm IV (bleomycin, etoposide, cisplatin)Experimental treatment 9 interventions
Group E: Low-Risk (observation)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Overall survival

The time from study entry to the date of death, or date of last contact and ascertained as alive, whichever comes first.

Time frame
Two years post enrollment
2

Event-free survival

The time from study entry to the date of death, date of disease progression or recurrence, date of second malignant neoplasm or date of last contact and ascertained as alive, whichever comes first.

Time frame
Two years post enrollment

Secondary outcomes

1

Presence of hearing loss

The hearing loss is evaluated according to the International Society of Pediatric Oncology criteria.

Time frame
8 weeks after the last dose of platin therapy
2

Adolescents and Young Adults-Hearing Screen (AYA HEARs)

AYA HEARs is a 9-item questionnaire with each question scored on a 5-point Likert scale (range = 0-4).

Time frame
Baseline, end of therapy, 2 months post-end of therapy, and 1 year after enrollment
3

Whole body lean body mass

Imaging and radiology reports will be analyzed using Slice-O-Matic software (Tomovision), and imaging results will be used to calculate whole-body lean body mass.

Time frame
At diagnosis, at end of therapy, and up to 1 year after end of therapy

Other outcomes

1

Event-free survival (EFS) for participants with and without tumor marker decline

Tumor marker decline is coded as yes versus no. The hazard ratio for participants with and without tumor marker decline will be presented. Patients who receive chemotherapy will be analyzed separately than patients in the low risk stratum.

Time frame
Up to 2 years
2

Self-reported peripheral neuropathy score

Self-reported peripheral neuropathy will be assessed using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale.

Time frame
Up to 12 months after end of therapy
3

Presence of residual tumor

A patient will be considered to have residual tumor if the patient has a residual mass ≥ 1 cm at the completion of chemotherapy based on imaging reports.

Time frame
Up to 12 months
4

Serum mir-371a-3p levels

miR-371a-3p will be measured from frozen serum to estimate the association with time-to-relapse as well as sensitivity, specificity, negative predictive value, and positive predictive value.

Time frame
Within six weeks of surgery, at relapse (cases) or the time closest to the case's relapse (controls), and the timepoint immediately preceding the "relapse" timepoint, up to 2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Oncology Group

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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