Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study

Launched by NRG ONCOLOGY · Jul 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to give radiation therapy to patients with muscle-invasive bladder cancer, which means the cancer has grown into the muscle of the bladder. Researchers want to see if a shorter course of radiation treatment (called ultra-hypofractionated radiation) works just as well as the usual, slightly longer radiation treatment (called hypofractionated radiation) when combined with standard chemotherapy drugs. The goal is to treat the cancer effectively while possibly reducing side effects and making treatment quicker and easier for patients.

To be eligible for this study, patients need to have a certain type of bladder cancer confirmed by tests and have had surgery to remove as much of the tumor as possible before starting treatment. They should not have cancer that has spread to lymph nodes or other parts of the body, and must be generally healthy enough to receive chemotherapy and radiation. Participants can expect to receive chemotherapy along with either the shorter or the usual radiation treatment, and the doctors will carefully monitor their response to see which approach works best. This trial is currently not yet recruiting, and is open to adults of all genders who meet the health criteria.

Gender

ALL

Eligibility criteria

• 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. Fludeoxyglucose (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
• • Age ≥ 18
• • 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
• Exclusion Criteria:
• • -