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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT00053352

NCT00053352
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have a germ cell tumor located outside the brain that contains at least one of these tumor types: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (mixed tumors that also contain mature or immature teratoma may still qualify).
  • For lower-risk patients (note: this group is no longer enrolling as of January 2010): you have a Stage I tumor of the ovary or testicle, and full surgical and imaging tests have been done to confirm it has not spread further.
  • For intermediate-risk patients, you have one of the following: a Stage II, III, or IV malignant testicular germ cell tumor; a Stage II or III malignant ovarian germ cell tumor; a Stage I or II malignant germ cell tumor that started outside the ovaries or testicles; or your tumor has come back after previously being monitored as a lower-risk case.
  • You have had specific blood tumor marker tests done (alpha-fetoprotein and beta-hCG), and if more than 5 days have passed since the original tests, they have been repeated before joining the trial.
  • You are enrolling within 6 weeks of your original surgery to remove or diagnose the tumor.
  • Your kidneys are working well enough, based on age- and gender-specific blood test results (confirm with trial site for the exact values that apply to you).
  • You have not had any chemotherapy before joining this trial.
  • You have not had any radiation therapy before joining this trial.

Who may not be able to join:

  • You have a Stage IV ovarian germ cell tumor or a Stage III–IV germ cell tumor that started outside the ovaries or testicles.
  • Your germ cell tumor is located in the brain.
  • Your tumor is purely mature teratoma, immature teratoma, dysgerminoma, or seminoma, with no other malignant germ cell component.
  • Your tumor contains non-germ cell cancer elements, such as primitive neuroectodermal tumor or rhabdomyosarcoma.
  • Your kidney function test results are below the required levels for your age and gender (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Children's Oncology Group
Registry
clinicaltrials_gov
Start date
3 November 2003
Est. completion
1 October 2013

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇳🇿 New Zealand Puerto Rico 🇨🇭 Switzerland 🇺🇸 United States

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Event-Free Survival (EFS); Overall Survival (OS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov