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RECRUITING Phase 3

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

NCT07097142 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Cisplatin
  • DRUG Fluorouracil
  • DRUG Gemcitabine

Study Locations (20)

Delaware

  • Beebe Medical Center — Lewes
  • Beebe South Coastal Health Campus — Millville
  • Helen F Graham Cancer Center — Newark
  • Medical Oncology Hematology Consultants PA — Newark
  • Christiana Care Health System-Christiana Hospital — Newark
  • Beebe Health Campus — Rehoboth Beach
  • Christiana Care Health System-Wilmington Hospital — Wilmington

Florida

  • UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach
  • UM Sylvester Comprehensive Cancer Center at Doral — Doral
  • University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami
  • Miami Cancer Institute — Miami
  • UM Sylvester Comprehensive Cancer Center at Kendall — Miami
  • UM Sylvester Comprehensive Cancer Center at Plantation — Plantation

California

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine
  • UC San Diego Moores Cancer Center — La Jolla
  • UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange
  • University of California Davis Comprehensive Cancer Center — Sacramento

Arkansas

  • Mercy Hospital Fort Smith — Fort Smith

Georgia

  • Grady Health System — Atlanta

Trial Details

FieldValue
Enrollment Target 486 participants
Start Date 2026-05-11
Est. Completion 2030-05-31
Phase Phase 3

Sponsor

NRG Oncology

162 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07097142

The ClinicalTrials.gov registry entry for NCT07097142 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 486 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NRG Oncology, which has 162 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Stage II Bladder Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07097142 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Delaware, Florida, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07097142 about?

NCT07097142 is a clinical study titled "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 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 ...

What is the current status of trial NCT07097142?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 486 participants. The study started on 2026-05-11. Estimated completion is 2030-05-31.

What conditions does trial NCT07097142 study?

This clinical trial studies the following conditions: Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8, Muscle Invasive Bladder Urothelial Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07097142?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Cisplatin (DRUG), Fluorouracil (DRUG), Gemcitabine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07097142?

This trial is sponsored by NRG Oncology, which has 162 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07097142 being conducted?

This trial has 20 study locations across Arkansas, California, Delaware, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial