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NCT04968990 · ClinicalTrials.gov registry record · Phase 2
Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam Irradiation
A Phase 2 study of Wilms Tumor, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 260
- Enrollment target
- 1
- Study location
NCT04968990 is a Phase 2 study of Wilms Tumor that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 260 participants, roughly in line with the 275-participant average among 14 other Wilms Tumor trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT04968990, a Phase 2 study of Wilms Tumor, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 260 participants
- Enrollment target
- 1
- Study location
Study Summary
Participants are being asked to take part in this clinical trial, a type of research study, because the participants have a Wilms Tumor cancer. Primary Objectives To determine whether delivery of proton beam radiation to a conformal reduced target volume in the flank allows normal flank growth compared to the contralateral untreated side and non-irradiated patients. Secondary Objectives To deliver proton beam radiation to a conformal reduced target volume (partial kidney proton beam radiation therapy) in the affected kidney(s) for patients with Stage V (bilateral Wilms tumor) and specific involved surgical margins yielding no reduction in the high control rates seen with more traditional flank / whole kidney fields. Exploratory Objectives * Study the feasibility of sparing the residual kidney, spine and liver in patients requiring whole abdomen radiation therapy using either a proton beam treatment technique or intensity-modulated radiation therapy ( IMRT) photon based technique. * Study the feasibility of delivering whole lung radiation therapy with proton beams with the goals of sparing the developing breast tissue, heart structures, thyroid and liver. * Develop simultaneous xenografts and organoid models from the same starting material to study Wilms tumor biology and compare responses to chemotherapeutic agents. * Define the evolution of organ specific (kidney, liver, pancreas, etc.) abnormalities (laboratory studies) as an early marker of possible late end organ damage and their relationship to radiation. * Study and evaluate impact of proton therapy on the musculoskeletal system and physical performance and compare with photon therapy cases treated with classical treatment fields. * Assess CTC-AE and Pediatric Patient Reported Outcomes during radiation and in follow-up, correlating with disease, treatment and patient variables. * Correlate quantitative MRI values, including apparent diffusion coefficient (ADC) values, with histopathology findings post-su
Conditions Studied
Interventions
- PROCEDURE Surgical Resection
- DEVICE Proton Beam Radiation (PBRT)
- DRUG DD-4A Chemotherapy Regimen
- PROCEDURE Complete Surgical Resection
- PROCEDURE Partial Nephrectomy
Study Locations (1)
Tennessee
- St.Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2021-08-19 |
| Est. Completion | 2036-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04968990
The ClinicalTrials.gov registry entry for NCT04968990 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 275-participant average among 14 other Wilms Tumor trials with a reported enrollment target. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Wilms Tumor appearing as the primary indexed condition, and to 5 interventions - of which Surgical Resection is the first listed.
NCT04968990 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT04968990 about?
NCT04968990 is a clinical study titled "Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam Irradiation". Participants are being asked to take part in this clinical trial, a type of research study, because the participants have a Wilms Tumor cancer. Primary Objectives To determine whether delivery of proton beam radiation to a conformal reduced target volume in the flank allows normal flank growth com...
What is the current status of trial NCT04968990?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 260 participants. The study started on 2021-08-19. Estimated completion is 2036-12.
What conditions does trial NCT04968990 study?
This clinical trial studies the following conditions: Wilms Tumor.
What interventions are being tested in trial NCT04968990?
The interventions under investigation include: Surgical Resection (PROCEDURE), Proton Beam Radiation (PBRT) (DEVICE), DD-4A Chemotherapy Regimen (DRUG), Complete Surgical Resection (PROCEDURE), Partial Nephrectomy (PROCEDURE).
Who is sponsoring clinical trial NCT04968990?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04968990 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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