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Shorter-course versus standard-course radiation with chemotherapy for muscle-invasive bladder cancer

The Phase III Adaptive Radiation and Chemotherapy for Muscle Invasive Bladder Cancer Trial (ARCHER)

Phase 3 Interventional NRG Oncology · NCT07097142

This trial tests whether a much shorter course of radiation plus standard chemotherapy works as well as the usual shorter radiation schedule for people with muscle-invasive bladder cancer who are pursuing bladder-preserving treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment486 (estimated)
Ages18 Years and up
SexAll
SponsorNRG Oncology Academic / other
Drugs / interventionsradiation, chemotherapy
Locations211 sites (Fort Smith, Arkansas and 210 other locations)
Trial IDNCT07097142 on ClinicalTrials.gov

What this trial studies

This is a randomized phase III trial that compares ultra-hypofractionated stereotactic body radiation therapy (SBRT) to conventional hypofractionated radiation therapy, each given with one of several standard chemotherapy regimens (cisplatin, gemcitabine, or mitomycin-C with 5‑fluorouracil). Patients with cT2–T3, N0, M0 urothelial bladder cancer who have undergone TURBT are randomized to receive either 20 daily hypofractionated RT treatments or a shorter SBRT course, with biospecimen collection for ctDNA and other molecular assays. The primary endpoint is 3-year bladder-intact event-free survival with a non-inferiority margin of 10% (HR < 1.32); secondary endpoints include urinary and bowel toxicity, patient-reported outcomes, EFS, MFS, and overall survival. Exploratory analyses will test ctDNA, tissue-free minimal residual disease, and urine tumor DNA as biomarkers for recurrence and disease detection at progression.

Who should consider this trial

Good fit: Ideal candidates are adults with cT2–T3, N0, M0 urothelial carcinoma of the bladder who have had a TURBT and are eligible for bladder-preserving chemoradiation with cisplatin, gemcitabine, or mitomycin-C/5-FU.

Not a fit: Patients with T4 disease, node-positive or metastatic disease, small cell histology, or those who are ineligible for the planned chemotherapy or radiation are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, patients could maintain bladder function with similar cancer control while spending far less time receiving radiation.

How similar studies have performed: Hypofractionated radiation has shown encouraging results in bladder-preserving approaches, but ultra-hypofractionated SBRT in this setting is relatively novel and less proven.

Eligibility criteria

Show full inclusion / exclusion 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. 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

Where this trial is running

Fort Smith, Arkansas and 210 other locations

+161 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Muscle Invasive Bladder Urothelial CarcinomaStage II Bladder Cancer AJCC v8Stage IIIA Bladder Cancer AJCC v8
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.