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ARCHER Study: Shorter Radiation for Bladder Cancer

This study, called ARCHER, is comparing two ways of giving radiation therapy for muscle-invasive bladder cancer (a type of bladder cancer that has grown into the bladder wall). You would receive either the usual number of radiation treatments (hypofractionated radiation therapy) or a shorter number of radiation treatments (ultra-hypofractionated radiation therapy). Both groups will also receive standard chemotherapy with cisplatin, gemcitabine, or fluorouracil. Researchers want to see if the shorter radiation treatment works as well as the usual treatment in keeping your bladder intact and free of cancer events for up to three years. To join, you must have cT2-T3,N0M0 urothelial carcinoma of the bladder and have had a transurethral resection of bladder tumor (TURBT). The study plans to enroll 486 participants, but its current status is unclear.

Study design
This is an interventional study comparing two different radiation therapy schedules. It aims to enroll 486 participants.
What's involved
You would undergo blood, tissue, and urine sample collection, and receive IV chemotherapy (cisplatin, fluorouracil, or gemcitabine) and radiation therapy. You would also have CT scans.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, bladder-intact event-free survival, is measured for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07097142

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
NRG Oncology
~486 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCisplatinComputed TomographyFluorouracilGemcitabineHypofractionated Radiation Therapy

At a glance

Recruiting sites
204 of 211 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bladder-intact event-free survival (BI-EFS)
Measured over Up to 3 years

Conditions

Muscle Invasive Bladder Urothelial Carcinoma
Stage II Bladder Cancer AJCC v8
Stage IIIA Bladder Cancer AJCC v8

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Bladder Carcinoma

NCT07097142

Where you'd take part

This study runs at 211 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

  • Allegiance Health

    Jackson, Michiganstudy coordinator listed

    Recruiting

  • Ascension Via Christi Hospitals Wichita

    Wichita, Kansasstudy coordinator listed

    Recruiting

  • Aspirus Cancer Care - James Beck Cancer Center

    Rhinelander, Wisconsinstudy coordinator listed

    Recruiting

  • Aspirus Cancer Care - Stevens Point

    Stevens Point, Wisconsinstudy coordinator listed

    Recruiting

  • Aspirus Cancer Care - Wisconsin Rapids

    Wisconsin Rapids, Wisconsinstudy coordinator listed

    Recruiting

  • Aspirus Regional Cancer Center

    Wausau, Wisconsinstudy coordinator listed

    Recruiting

  • Beacon Kalamazoo

    Kalamazoo, Michiganstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Scott E Delacroix · PRINCIPAL_INVESTIGATOR · NRG Oncology

Who to contact

Site Public Contact
800-378-9373
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Eligibility criteria

Inclusion

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
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

What this trial measures

  • Bladder-intact event-free survival (BI-EFS)Up to 3 years

    Defined as histologically proven presence of muscle invasive bladder cancer (MIBC), radiographic evidence of nodal or metastatic disease, performance of radical cystectomy, or death from any cause. Time to event will be calculated from the date of randomization. BI-EFS will be estimated in the two treatment groups using the Kaplan-Meier method and the hazard ratio between ultra-hypofractionation and hypofractionation estimated by fitting a Cox proportional hazards regression model, including a treatment arm indicator variable and adjusting for the three stratification factors employed in the randomization.