Phase 3 Ovarian Cancer Trial, Completed NCT00053352 Sponsor: Children's Oncology Group Condition: Ovarian Cancer
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 302 participants across two groups: 190 people in Arm 1 and 112 people in Arm 2. Of those, 169 in Arm 1 and 102 in Arm 2 completed the study. The trial was measuring how many participants survived and remained free of disease-related events over three years, as well as looking at hospital stay length and certain side effects for those in Arm 1 who received chemotherapy. The reported data shows that for Arm 1, the probability of being alive at three years was reported as 97%, and the probability of being free from disease-related events (such as relapse or the need to change treatment) at three years was reported as 87%. For Arm 2, the probability of being alive at three years was reported as 99%. Event-free survival was not measured as a primary outcome for Arm 2 participants. For those in Arm 1 who received chemotherapy, the average number of days spent in hospital was reported as approximately 14 days. The reported data also shows that a number of Arm 1 participants experienced serious side effects (graded as severe or higher on a standard medical scale) during treatment — the most commonly reported category involved 58 patients, with smaller numbers reported across other side effect categories. The full breakdown of each specific side effect type was not included in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Ovarian Cancer Trial, Completed

NCT00053352
Completed Phase 3 🇦🇺 Australian site

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • 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

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • 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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026

Trial contact details on record

Principal Investigator: Anne Frazier, MD, Children's Oncology Group

Australian sites

The Children's Hospital at Westmead, Sydney, New South Wales
Princess Margaret Hospital for Children, Perth, Western Australia

This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.

GP referral letter

Print a one-page summary to share with your doctor.

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 was run

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

These are the locations recorded on the registry, including 2 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

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

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov