Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study
Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study
This phase III trial compares the effect of shorter term radiation (ultra-hypofractionated) therapy to the usual radiation therapy (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 shorter period of time and may kill more tumor cells and have fewer side effects. 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.
Bladder
Phase III
Adults
Chemotherapy - cytotoxic,
Radiotherapy
Cisplatin,
Fluorouracil (5-FU),
Gemcitabine,
Mitomycin-C
Kirschner, Austin
National
Vanderbilt University
12-23-2025
Eligibility
18 Years and older
ALL
false
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:
\-
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:
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