Trial · NCT03067181
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
NCT03067181, Phase 3, Recruiting, Children's Oncology Group
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors. Trials, record NCT03067181. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03067181
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
- NCT number
- NCT03067181
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 1,780 participants, estimated
- Lead sponsor
- Children's Oncology Group
- Conditions
Childhood Extracranial Germ Cell Tumor, Extragonadal Embryonal Carcinoma, Germ Cell Tumor, Malignant Germ Cell Tumor, Malignant Ovarian Teratoma, Stage I Ovarian Choriocarcinoma, Stage I Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7, Stage I Testicular Choriocarcinoma AJCC v6 and v7, Stage I Testicular Embryonal Carcinoma AJCC v6 and v7, Stage I Testicular Seminoma AJCC v6 and v7, Stage I Testicular Yolk Sac Tumor AJCC v6 and v7, Stage II Ovarian Choriocarcinoma, Stage II Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7, Stage II Testicular Choriocarcinoma AJCC v6 and v7, Stage II Testicular Embryonal Carcinoma AJCC v6 and v7, Stage II Testicular Yolk Sac Tumor AJCC v6 and v7, Stage III Ovarian Choriocarcinoma, Stage III Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7, Stage III Testicular Choriocarcinoma AJCC v6 and v7, Stage III Testicular Embryonal Carcinoma AJCC v6 and v7, Stage III Testicular Yolk Sac Tumor AJCC v6 and v7, Stage IV Ovarian Choriocarcinoma, Stage IV Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7, Testicular Mixed Choriocarcinoma and Embryonal Carcinoma, Testicular Mixed Choriocarcinoma and Teratoma, Testicular Mixed Choriocarcinoma and Yolk Sac Tumor
- Interventions
Best Practice, Biopsy Procedure, Biospecimen Collection, Bleomycin Sulfate, Carboplatin, Cisplatin, Computed Tomography, Etoposide, Magnetic Resonance Imaging, Pulmonary Function Test, Questionnaire Administration
- First posted
- 2017-03-01
- Last updated
- 2026-08-25
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival | Two years post enrollment | The time from study entry to the date of death, or date of last contact and ascertained as alive, whichever comes first. |
| Primary | Event-free survival | Two years post enrollment | 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. |
| Secondary | Presence of hearing loss | 8 weeks after the last dose of platin therapy | The hearing loss is evaluated according to the International Society of Pediatric Oncology criteria. |
| Secondary | Adolescents and Young Adults-Hearing Screen (AYA HEARs) | Baseline, end of therapy, 2 months post-end of therapy, and 1 year after enrollment | AYA HEARs is a 9-item questionnaire with each question scored on a 5-point Likert scale (range = 0-4). |
| Secondary | Whole body lean body mass | At diagnosis, at end of therapy, and up to 1 year after end of therapy | 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. |
| Other | Event-free survival (EFS) for participants with and without tumor marker decline | Up to 2 years | 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. |
| Other | Self-reported peripheral neuropathy score | Up to 12 months after end of therapy | Self-reported peripheral neuropathy will be assessed using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale. |
| Other | Presence of residual tumor | Up to 12 months | 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. |
| Other | Serum mir-371a-3p levels | 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 | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37783480 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03067181
GET https://conductscience.org/api/trials/v1/NCT03067181/registered