Is NCT07097142 recruiting in Highlands Ranch, CO?

Yes, NCT07097142 is currently recruiting participants at its Highlands Ranch, CO location. This muscle invasive bladder urothelial carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Highlands Ranch 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.

Muscle Invasive Bladder Urothelial Carcinoma Clinical Trial in Highlands Ranch, CO

Q: How do I join the muscle invasive bladder urothelial carcinoma clinical trial in Highlands Ranch?

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

About This Muscle Invasive Bladder Urothelial Carcinoma Study in Highlands Ranch

This phase III trial compares the effect of decreased number of radiation (ultra-hypofractionated) treatments to the usual radiation number of treatments (hypofractionation) with standard of care chemotherapy, with cisplatin, gemcitabine or mitomycin and 5-fluorouracil for the treatment of patients with muscle invasive bladder cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a short period of time. Ultra-hypofractionated radiation therapy delivers radiation over an even shorter period of time than hypofractionated radiation therapy. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Chemotherapy drugs, such as mitomycin-C and 5-fluorouracil (5-FU), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ultra-hypofractionated radiation may be equally effective as hypofractionated therapy for patients with muscle invasive bladder cancer.

Sponsor: NRG Oncology

Who Can Participate

Inclusion Criteria

Histologically proven, cT2-T3,N0M0 urothelial carcinoma of the bladder prior to randomization.

Note: Patients with mixed urothelial carcinoma will be eligible for the trial, but the presence of small cell carcinoma will make a patient ineligible

Must undergo a transurethral resection of bladder tumor (TURBT) prior to randomization. Patients may have either completely or partially resected tumors as long as the treating urologist attempted maximal resection

Must undergo radiological staging prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI (with or without contrast is acceptable). Patients must not have evidence of T4 or node positive disease. Fluorodeoxyglucose (FDG) PET imaging is acceptable for radiological staging

If any lymph nodes ≥ 1.0 cm in shortest cross-sectional diameter are noted on imaging (CT / MRI of abdomen and pelvis), then the patient must have had a biopsy of the enlarged lymph node showing no tumor involvement prior to randomization

No diffuse carcinoma in situ (CIS) based on cystoscopy and biopsy

No definitive clinical or radiologic evidence of metastatic disease

Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within 24 months prior to registration except Ta/T1/Carcinoma in situ (CIS) of the upper urinary tract including renal pelvis and ureter if the patient had undergone complete nephroureterectomy

Zubrod performance status of ≤ 2

Not pregnant and not nursing

Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal

Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3

Platelets ≥ 100,000 cells/mm\^3

Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\]) ≥ 8.0 g/dl is acceptable)

Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula

Total bilirubin ≤ 2 x institutional upper limit of normal (ULN)

Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN

All adverse events associated with any prior therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 3 prior to randomization

For patients who have completed neoadjuvant therapy, they are eligible if the pre-neoadjuvant therapy diagnosis (TURBT path) is within 180 days before randomization

Must not have had prior pelvic radiation

New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)

No active infection requiring IV antibiotics

Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meet criteria specified

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 Highlands Ranch?

Yes, this clinical trial (NCT07097142) has an active research site in Highlands Ranch, CO 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.

Muscle Invasive Bladder Urothelial Carcinoma Treatment Options in Highlands Ranch, CO

If you're searching for muscle invasive bladder urothelial carcinoma treatment options in Highlands Ranch, CO, this clinical trial (NCT07097142) 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 Highlands Ranch research site is actively enrolling participants for this clinical trial. You'll receive care from experienced muscle invasive bladder urothelial carcinoma 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 muscle invasive bladder urothelial carcinoma clinical trials near you to find additional studies recruiting in your area.

Muscle Invasive Bladder Urothelial Carcinoma Clinical Trial in Highlands Ranch, CO

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