Wilms TumorPhase 2NCT04968990
Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam Irradiation
A Phase 2 study testing Proton Beam Radiation (PBRT), DD-4A Chemotherapy Regimen and Complete Surgical Resection in people with Wilms Tumor, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wilms Tumor
- What is being tested?
- Proton Beam Radiation (PBRT), DD-4A Chemotherapy Regimen and Complete Surgical Resection
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2021to Dec 2036
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients are eligible to be enrolled on this trial at the time of initial (or presumptive) diagnosis of Wilms tumor, at the time of surgery or at the time of radiation treatment.
- Patients that are determined to be stage I or II will be eligible for the surgical and biologic aspects of this trial but will otherwise be followed per institutional standards and be "off therapy" at the time of stage determination (followed only for survival).
- Patients identified to have an anaplastic or other unfavorable tissue component (non-Wilms histology) to their tumor may have tissue assessed for the biology objective but will be removed from the therapeutic portion of the study at the time of identification of this pathologic finding.
- Performance Level • The Karnofsky performance status must be ≥50 for patients >16 years of age and the Lansky performance status must be ≥ 50 for patients ≤ 16 years of age.
- Prior Therapy
- Only prior therapy with the initial chemotherapy regimen defined in section 5.1 and Appendix III are allowed for patients that are treated with neoadjuvant chemotherapy. These patients may change to an alternate regime based on response or biologic features and noted in section 5.1. Prior biopsy or surgery is allowed.
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- Prior radiation therapy is not allowed if directed at the abdomen. Emergent RT to other sites of disease is acceptable.
- Organ Function Requirements:
- None - As per institutional standard of care. Diagnosis / Stage
- Presumed diagnosis of Wilms tumor (continued management on trial will depend on stage and histology)
- Resected upfront stage III, IV or V favorable histology Wilms tumor. Stage III includes any one or multiples of the following:
- Lymph nodes within the abdomen or pelvis are involved by tumor. (Lymph node involvement in the thorax, or other extra-abdominal sites is a criterion for Stage IV)
- The tumor has penetrated through the peritoneal surface
- Tumor implants are found on the peritoneal surface
- Gross or microscopic tumor remains post-operatively (e.g., tumor cells are found at the margin of surgical resection on microscopic examination - in the post chemotherapy setting only specific types of viable tumor at the surgical margin are considered stage III AND require adjuvant radiation - see surgery / pathology / radiation section for additional details)
- The tumor is not completely resectable because of local infiltration into vital structures
- Tumor spillage occurring either before or during surgery
- A trans abdominal biopsy (regardless of type- tru-cut, open or fine needle aspiration) was performed prior to resection or chemotherapy. Retroperitoneal biopsies DO NOT require radiotherapeutic management like stage III
- Tumor is removed in greater than one piece (e.g. tumor cells are found in a separately excised adrenal gland; a tumor thrombus within the renal vein is removed separately from the nephrectomy specimen). Extension of the primary tumor within vena cava into thoracic vena cava and heart is considered Stage III, rather than Stage IV even though outside the abdomen.
- Stage IV - Hematogenous metastases (lung, liver, bone, brain, etc.), or lymph node metastases outside the abdomino-pelvic region are present. (The presence of tumor within the adrenal gland is not interpreted as metastasis and staging depends on all other staging parameters present). Patients with lung involvement and local abdominal stage I or II are eligible to remain on trial for whole lung irradiation objective.
- Stage V - Bilateral renal involvement by tumor is present at diagnosis. An attempt should be made to stage each side according to the above criteria on the basis of the extent of disease
- Patients that have or will receive neoadjuvant chemotherapy for unresected unilateral or bilateral Wilms tumor without a biopsy are not assumed to be require adjuvant radiation on this study. That determination will be based on surgical findings and the approach to treatment detailed in the protocol.
- Timing
- Patients undergoing upfront surgery must start RT, if indicated, within 28 days of definitive surgery with a goal of starting RT by day 21.
- Patients receiving neoadjuvant chemotherapy will be enrolled either at diagnosis (if at St. Jude) or at the time of RT.
- Other Criteria
- Female patients of childbearing potential (age ≥10 years old or post-menarche) must have a negative pregnancy test prior to enrollment.
Who cannot join
- Inability or unwillingness to provide written informed consent
- Prior radiation therapy to a site to be treated with proton / photon radiation as part of this trial. Emergent radiation is allowed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St.Jude Children's Research Hospital
Memphis, Tennessee, 38105
Matthew J Krasin, MD, 888-226-4343, referralinfo@stjude.org
Matthew J Krasin, MD
About this study
Official title: Multi-Center Trial Sponsored by St. Jude Children's Research Hospital for the 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
Read more
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-surgery in children with (bilateral) Wilms.
- Assess daily variations in proton range along each treatment beam using standard pre-treatment cone beam CT or on-treatment MR.
Read the detailed description
Participants will receive proton beam radiation therapy (PBRT) according to stage and surgical findings.
Favorable Histology Stage I \& II and FH Stage III/IV Delayed Local Control with clear surgical margins and pathologically negative lymph nodes: Participants will undergo complete surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy. PBRT will not be administered to the primary site in those with no evidence of spill, peritoneal involvement, lymph node (LN) involvement or microscopic residual in the abdomen. Systemic therapy will be delivered in a standard of care manner according to histology and stage.
Stage III \& IV Adjuvant RT: Participants will undergo surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy. Those with evidence of LN involvement, surgical margin involvement, local or diffuse spill, gross disease in the renal bed or peritoneal implants, will receive adjuvant PBRT. Systemic therapy will be delivered in a standard of care manner according to histology and stage.
Stage V Adjuvant RT: Participants will undergo partial nephrectomy after 6-12 weeks of induction chemotherapy. Those with evidence of LN involvement, surgical margin involvement, local or diffuse spill, gross disease in the renal bed or peritoneal implants, will receive adjuvant PBRT. Systemic therapy will be delivered in a standard of care manner according to histology and stage.
Systemic therapy will follow a well-defined standard of care based on Children's Oncology Group (COG) approaches including pre-operative chemotherapy and adjuvant chemotherapy. The intent will be to standardize chemotherapy to ensure a consistent background of standard of care therapy, while not mandating additional data collection beyond the specific trial objectives.
- Conditions
- Wilms Tumor
- Being tested
- Proton Beam Radiation (PBRT), DD-4A Chemotherapy Regimen, Complete Surgical Resection, Surgical Resection, Partial Nephrectomy
- Keywords
- Retroperitoneum, Retroperitoneal subsites, Kidney, Lymph node involvement, Abdomen
- Medical subject headings
- Wilms Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Beam Radiation (PBRT)Device
The treatment approach with radiation therapy prescribed in this trial is designed to deliver highly conformal radiation therapy (proton beam radiation or intensity modulated photon radiation) to target volumes that are based on the burden of disease.
DD-4A Chemotherapy RegimenDrug
Patients will receive standard of care chemotherapy based on diagnosis and stage.
Complete Surgical ResectionProcedure or surgery
Participants will undergo complete surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy
Surgical ResectionProcedure or surgery
Participants will undergo surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy.
Partial NephrectomyProcedure or surgery
Participants will undergo partial nephrectomy after 6-12 weeks of induction chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Favorable Histology Stage I & II and FH Stage III/IV | Active comparator | Favorable Histology Stage I \& II and FH Stage III/IV Delayed Local Control with clear surgical margins and pathologically negative lymph nodes. Participants will undergo complete surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy. Receives: Procedure: Complete Surgical Resection |
| Stage III & IV Adjuvant RT and Stage V | Active comparator | Participants will undergo surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy. Those with evidence of LN involvement, surgical margin involvement, local or diffuse spill, gross disease in the renal bed or peritoneal implants, will receive adjuvant PBRT. Receives: Device: Proton Beam Radiation (PBRT); Drug: DD-4A Chemotherapy Regimen; Procedure: Surgical Resection |
| Stage V Adjuvant RT: | Active comparator | Participants will undergo partial nephrectomy after 6-12 weeks of induction chemotherapy. Those with evidence of LN involvement, surgical margin involvement, local or diffuse spill, gross disease in the renal bed or peritoneal implants, will receive adjuvant PBRT Receives: Device: Proton Beam Radiation (PBRT); Drug: DD-4A Chemotherapy Regimen; Procedure: Partial Nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Half circumference at 3 year
Half circumference measurement at 3 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation
Measured: 3 years after all patients finish proton therapy
Half circumference at 5 year
Half circumference measurement at 5 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation
Measured: 5 years after all patients finish proton therapy
Half circumference at 7 year
Half circumference measurement at 7 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation
Measured: 7 years after all patients finish proton therapy
Half circumference at 10 year
Half circumference measurement at 10 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation
Measured: Half circumference measurement at 10 year from irradiated and unirradiated hemi-abdomen
Secondary outcomes (1)
Local control rate in a partially radiated kidney
This objective is to investigate whether deliver proton beam radiation to a conformal reduced target volume (partial kidney proton beam radiation therapy) in the affected kidney(s) for patients Stage V (bilateral Wilms tumor) with specific involved surgical margins yielding no reduction in the high control rates seen with more traditional flank / whole kidney fields.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start19 Aug 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wilms TumorStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew J Krasin, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968990
- Sponsor's protocol ID
- SJWT21
- Status last verified
- Apr 2026
- First submitted
- 9 Jul 2021
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Trial Sponsored by St. Jude Children's Research Hospital for the Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam Irradiation
- ClinicalTrials.gov ID
- NCT04968990
- Acronym / sponsor ID
- SJWT21
- Conditions
- Wilms Tumor
- Keywords
- Retroperitoneum, Retroperitoneal subsites, Kidney, Lymph node involvement, Abdomen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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-surgery in children with (bilateral) Wilms.
- Assess daily variations in proton range along each treatment beam using standard pre-treatment cone beam CT or on-treatment MR.
Detailed description
Participants will receive proton beam radiation therapy (PBRT) according to stage and surgical findings.
Favorable Histology Stage I \& II and FH Stage III/IV Delayed Local Control with clear surgical margins and pathologically negative lymph nodes: Participants will undergo complete surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy. PBRT will not be administered to the primary site in those with no evidence of spill, peritoneal involvement, lymph node (LN) involvement or microscopic residual in the abdomen. Systemic therapy will be delivered in a standard of care manner according to histology and stage.
Stage III \& IV Adjuvant RT: Participants will undergo surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy. Those with evidence of LN involvement, surgical margin involvement, local or diffuse spill, gross disease in the renal bed or peritoneal implants, will receive adjuvant PBRT. Systemic therapy will be delivered in a standard of care manner according to histology and stage.
Stage V Adjuvant RT: Participants will undergo partial nephrectomy after 6-12 weeks of induction chemotherapy. Those with evidence of LN involvement, surgical margin involvement, local or diffuse spill, gross disease in the renal bed or peritoneal implants, will receive adjuvant PBRT. Systemic therapy will be delivered in a standard of care manner according to histology and stage.
Systemic therapy will follow a well-defined standard of care based on Children's Oncology Group (COG) approaches including pre-operative chemotherapy and adjuvant chemotherapy. The intent will be to standardize chemotherapy to ensure a consistent background of standard of care therapy, while not mandating additional data collection beyond the specific trial objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Favorable Histology Stage I & II and FH Stage III/IV | Active comparator | Procedure: Complete Surgical ResectionFavorable Histology Stage I \& II and FH Stage III/IV Delayed Local Control with clear surgical margins and pathologically negative lymph nodes. Participants will undergo complete surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy. |
| Stage III & IV Adjuvant RT and Stage V | Active comparator | Device: Proton Beam Radiation (PBRT), Drug: DD-4A Chemotherapy Regimen, Procedure: Surgical ResectionParticipants will undergo surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy. Those with evidence of LN involvement, surgical margin involvement, local or diffuse spill, gross disease in the renal bed or peritoneal implants, will receive adjuvant PBRT. |
| Stage V Adjuvant RT: | Active comparator | Device: Proton Beam Radiation (PBRT), Drug: DD-4A Chemotherapy Regimen, Procedure: Partial NephrectomyParticipants will undergo partial nephrectomy after 6-12 weeks of induction chemotherapy. Those with evidence of LN involvement, surgical margin involvement, local or diffuse spill, gross disease in the renal bed or peritoneal implants, will receive adjuvant PBRT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (27 listed)
- Patients are eligible to be enrolled on this trial at the time of initial (or presumptive) diagnosis of Wilms tumor, at the time of surgery or at the time of radiation treatment.
- Patients that are determined to be stage I or II will be eligible for the surgical and biologic aspects of this trial but will otherwise be followed per institutional standards and be "off therapy" at the time of stage determination (followed only for survival).
- Patients identified to have an anaplastic or other unfavorable tissue component (non-Wilms histology) to their tumor may have tissue assessed for the biology objective but will be removed from the therapeutic portion of the study at the time of identification of this pathologic finding.
- Performance Level • The Karnofsky performance status must be ≥50 for patients >16 years of age and the Lansky performance status must be ≥ 50 for patients ≤ 16 years of age.
- Prior Therapy
Key exclusion criteria (2 listed)
- Inability or unwillingness to provide written informed consent
- Prior radiation therapy to a site to be treated with proton / photon radiation as part of this trial. Emergent radiation is allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton Beam Radiation (PBRT)The treatment approach with radiation therapy prescribed in this trial is designed to deliver highly conformal radiation therapy (proton beam radiation or intensity modulated photon radiation) to target volumes that are based on the burden of disease. | Device | Stage III & IV Adjuvant RT and Stage V, Stage V Adjuvant RT: |
| DD-4A Chemotherapy RegimenPatients will receive standard of care chemotherapy based on diagnosis and stage. | Drug | Stage III & IV Adjuvant RT and Stage V, Stage V Adjuvant RT: |
| Complete Surgical ResectionParticipants will undergo complete surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy | Procedure or surgery | Favorable Histology Stage I & II and FH Stage III/IV |
| Surgical ResectionParticipants will undergo surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy. | Procedure or surgery | Stage III & IV Adjuvant RT and Stage V |
| Partial NephrectomyParticipants will undergo partial nephrectomy after 6-12 weeks of induction chemotherapy. | Procedure or surgery | Stage V Adjuvant RT: |
Primary outcome
Half circumference at 3 year
Time frame: 3 years after all patients finish proton therapy
Half circumference measurement at 3 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation
Half circumference at 5 year
Time frame: 5 years after all patients finish proton therapy
Half circumference measurement at 5 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation
Half circumference at 7 year
Time frame: 7 years after all patients finish proton therapy
Half circumference measurement at 7 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation
Half circumference at 10 year
Time frame: Half circumference measurement at 10 year from irradiated and unirradiated hemi-abdomen
Half circumference measurement at 10 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation
1 secondary outcome
Local control rate in a partially radiated kidney
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- St.Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew J Krasin, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Proton Beam Radiation (PBRT), DD-4A Chemotherapy Regimen and Complete Surgical Resection in people with Wilms Tumor, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew J Krasin, MD (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Half circumference at 3 year (time frame: 3 years after all patients finish proton therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.