Is NCT04968990 recruiting in Memphis, TN?

Yes, NCT04968990 is currently recruiting participants at its Memphis, TN location. This wilms tumor clinical trial is actively enrolling qualified participants.

How do I join the wilms tumor clinical trial in Memphis?

To join this clinical trial in Memphis, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Memphis clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Wilms Tumor Clinical Trial in Memphis, TN

About This Wilms Tumor Study in Memphis

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.

Sponsor: St. Jude Children's Research Hospital

Who Can Participate

Inclusion Criteria

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.

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.

Exclusion Criteria

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Memphis?

Yes, this clinical trial (NCT04968990) has an active research site in Memphis, TN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Wilms Tumor Treatment Options in Memphis, TN

If you're searching for wilms tumor treatment options in Memphis, TN, this clinical trial (NCT04968990) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Memphis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced wilms tumor specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all wilms tumor clinical trials near you to find additional studies recruiting in your area.

Wilms Tumor Clinical Trial in Memphis, TN

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