Phase 2 Kidney Cancer Trial, Recruiting NCT04968990 Sponsor: St. Jude Children's Research Hospital Condition: Kidney Cancer
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Phase 2 Kidney Cancer Trial, Recruiting

NCT04968990
Recruiting Phase 2

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:

  • People who have been newly diagnosed with Wilms tumor (a type of kidney cancer), or are suspected to have it, at the time of first diagnosis, surgery, or radiation treatment.
  • People whose tumor is found to be Stage I or II may take part in the surgical and biological parts of the trial, but will otherwise be monitored using standard care at their hospital rather than receiving trial-specific treatment.
  • People whose tumor contains certain unfavorable tissue types may have their tissue studied for research purposes, but will be removed from the treatment part of the trial if this is discovered.
  • People who are well enough to carry out some self-care — specifically, adults over 16 must meet a minimum health/activity score of 50 on the Karnofsky scale, and children 16 and under must meet a score of 50 on the Lansky scale (confirm with trial site).
  • People who received only the specific initial chemotherapy regimen outlined in the trial protocol before joining, if they had chemotherapy before surgery. Prior biopsy or surgery is also allowed.
  • People with a suspected or confirmed Wilms tumor that is Stage III, IV, or V with favorable tissue type, or lung involvement at Stage I or II, as defined by specific surgical and pathology findings (confirm with trial site for exact staging details).
  • People receiving chemotherapy before surgery (neoadjuvant chemotherapy) for unremoved tumors affecting one or both kidneys, without a prior biopsy, may join either at diagnosis or at the time radiation treatment begins.
  • People who need to start radiation therapy after upfront surgery must be able to begin within 28 days of that surgery, with a goal of starting by day 21.
  • Female patients aged 10 or older, or those who have started their menstrual cycle, must have a negative pregnancy test before joining.

Who may not be able to join:

  • People who are unable or unwilling to provide written consent to participate.
  • People who have previously had radiation therapy directed at the abdomen (radiation to other areas in an emergency situation is allowed).
  • People who have previously received radiation to any area of the body that would need to be treated with proton or photon radiation as part of this trial (emergency radiation is an exception).
  • People whose tumor has been found to have an unfavorable or non-Wilms tissue type will be removed from the treatment portion of the trial at the time that finding is confirmed.

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 28 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: Matthew J Krasin, MD, St. Jude Children's Research Hospital

Phone: 888-226-4343

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
St. Jude Children's Research Hospital
Registry
ClinicalTrials.gov
Start date
19 August 2021
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Half circumference at 3 year; Half circumference at 5 year; Half circumference at 7 year; Half circumference at 10 year

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: 28 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