Phase 2 Kidney Cancer Trial, Recruiting NCT04322318 Sponsor: Children's Oncology Group Condition: Kidney Cancer
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Phase 2 Kidney Cancer Trial, Recruiting

NCT04322318
Recruiting Phase 2 🇦🇺 Australian site

Who may 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 might be able to join this trial:

  • You are 30 years old or younger at the time of joining the study
  • You have been newly diagnosed with stages 2, 3, or 4 diffuse anaplastic Wilms tumor (a specific type of kidney cancer), confirmed by a central medical review team
  • You have a type of kidney cancer called favorable histology Wilms tumor that has come back (relapsed) after previously being in remission, and you have not yet received treatment for the relapse
  • Your cancer diagnosis has been confirmed through a tissue sample (biopsy or surgery); for relapsed cases, proof of relapse through biopsy is encouraged but not always required
  • You are generally well enough to carry out normal daily activities, or have only mild limitations (confirm with trial site)
  • You are expected to live for at least 8 weeks or more
  • Your blood counts are at an acceptable level — specifically, your infection-fighting cells (neutrophils), platelets, and red blood cells meet the minimum levels required, tested within 7 days before joining
  • Your kidneys are working well enough, based on blood or urine tests done within 7 days before joining
  • Your liver is functioning within acceptable limits, based on blood tests done within 7 days before joining
  • Your heart is pumping well enough, confirmed by a heart scan done within 21 days before joining
  • If you have newly diagnosed diffuse anaplastic Wilms tumor and had surgery to remove the kidney (nephrectomy), at least one nearby lymph node was checked during that surgery
  • You have been enrolled in a related screening study called APEC14B1 (required for newly diagnosed diffuse anaplastic Wilms tumor patients only; not required for relapsed cases)

Who may not be able to join:

  • You have had Wilms tumor in both kidneys at any point (either at the same time or one after the other)
  • You have an uncontrolled infection or any serious uncontrolled illness
  • You have moderate or severe heart failure symptoms
  • You are a relapsed favorable histology Wilms tumor patient who either received no chemotherapy initially, or only received one chemotherapy drug as first treatment
  • You have a kidney condition called renal tubular acidosis, shown by specific abnormal blood results — this applies to high-risk and very high-risk relapsed favorable histology Wilms tumor patients (confirm with trial site)
  • You have chronic inflammatory bowel disease or a bowel blockage — this applies to certain patient groups (confirm with trial site)
  • You are currently taking a herbal supplement called St. John's Wort and are unable to stop before starting the trial — this applies to certain patient groups
  • You are currently pregnant (a pregnancy test will be required if you could become pregnant)
  • You are currently breastfeeding and plan to continue breastfeeding during the study
  • You are sexually active and able to have children, but have not agreed to use effective birth control for the entire time you are in the study
  • You have received another experimental or investigational treatment within 4 weeks before joining this trial
  • You have already received chemotherapy for your relapsed Wilms tumor (for relapsed patients only)

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 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: James I Geller, Children's Oncology Group

Australian sites

John Hunter Children's Hospital, Hunter Regional Mail Centre, New South Wales
Sydney Children's Hospital, Randwick, New South Wales
The Children's Hospital at Westmead, Westmead, New South Wales
Queensland Children's Hospital, South Brisbane, Queensland
61 7 3068 1111
Women's and Children's Hospital-Adelaide, North Adelaide, South Australia
(08) 8161 7327
Monash Medical Center-Clayton Campus, Clayton, Victoria
Royal Children's Hospital, Parkville, Victoria
61 3 9345 5656
Perth Children's Hospital, Perth, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Children's Oncology Group
Registry
ClinicalTrials.gov
Start date
19 October 2020
Est. completion
1 July 2027

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇳🇿 New Zealand Puerto Rico 🇸🇦 Saudi Arabia 🇺🇸 United States

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

Primary endpoints

Event-free survival (EFS) for stratum 1-3; EFS for stratum 4

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: 26 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