Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam Irradiation

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT04968990
Phase
PHASE2
Status
Recruiting
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Conditions

  • Wilms Tumor

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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 Regimen — DRUG
    Patients will receive standard of care chemotherapy based on diagnosis and stage.
  • Complete Surgical Resection — PROCEDURE
    Participants will undergo complete surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy
  • Surgical Resection — PROCEDURE
    Participants will undergo surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy.
  • Partial Nephrectomy — PROCEDURE
    Participants will undergo partial nephrectomy after 6-12 weeks of induction chemotherapy.

Study Details

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.

Key Dates

Start date
Aug 19, 2021
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2036

Study Design

Enrollment
260 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: Favorable Histology Stage I & II and FH Stage III/IV
    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.
  • Active Comparator: Stage III & IV Adjuvant RT and Stage V
    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.
  • Active Comparator: 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

Primary Outcome Measure

Half circumference at 3 year [ Time Frame: 3 years after all patients finish proton therapy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St.Jude Children's Research HospitalMemphisTennessee38105
Matthew J Krasin, MD
[email protected]
888-226-4343
Matthew J Krasin, MD (PRINCIPAL_INVESTIGATOR)

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By research site
St.Jude Children's Research Hospital· Memphis, TN

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