Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach (ARTIA-Vesica)

Daily Online Adaptive Radiation Therapy of Bladder Cancer for Reduction of Intestinal Toxicity: A Prospective Trial Using an Individualized Approach and Conventional Fractionation (ARTIA-Vesica)

This is a single-arm, prospective, Phase II, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for muscle invasive bladder cancer will translate into a decreased rate of acute gastrointestinal toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT).

Study Overview

• Status: Active, not recruiting
• Conditions: Muscle-Invasive Bladder Carcinoma
• Intervention / Treatment: Device: Varian Ethos Adaptive Radiation Therapy

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, DK-2730
    • Herlev and Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Histologically proven bladder cancer
2. Urothelial carcinoma
3. Age ≥ 18 years
4. Stage T1b-T4AN0M0
5. TUR-B and PET-CT or CT of thorax/abdomen/pelvis within 8 weeks prior to inclusion
6. Suitable for radiotherapy
7. ECOG/WHO performance status 0-2
8. Written informed consent

9. For Cohort B, participant's must have normal organ and marrow function as defined below:

   • leukocytes ≥2,500/mcL
   • absolute neutrophil count ≥1,500/mcL
   • platelets ≥100,000/mcL
   • hemoglobin ≥9 g/dL
   • total bilirubin ≤ 1,5 ULN
   • AST(SGOT)/ALT(SGPT) ≤3 × ULN
   • alkaline phosphatase ≤2.5 × ULN
   • creatinine clearance <25 ml/min We recommend avoiding cisplatin for participants with creatinine clearance <50 ml/min.
   • INR and aPTT £1.5 ULN

Exclusion Criteria:

1. Prior pelvic radiation therapy
2. Inability to comply with the protocol
3. Presence of a hip prothesis
4. Grade 2 or greater baseline diarrhea
5. Uncontrolled inflammatory bowel disease (ulcerative colitis or Crohn's disease)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daily Adaptive External Beam Radiation Therapy; Daily adaptive radiation therapy delivered with Varian Ethos treatment system.	Device: Varian Ethos Adaptive Radiation Therapy; Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Rate CTCAE GI Toxicity	Change of the peak early rate of external beam radiation therapy treatment-related (CTCAE) grade 2+ diarrhea	Start of radiotherapy to 3 months after end of radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Early CTCAE Treatment Related Toxicities	All early adaptive radiation therapy treatment related CTCAE grade 2 and above toxicity	From start of radiotherapy through 3 months after end of radiotherapy
All Late CTCAE Treatment Related Toxicities	All late CTCAE adaptive radiation therapy treatment related toxicity grade 2 and above	From 3 months after end of radiotherapy through 2 years follow-up
Patient Reported Outcomes (PRO)	Collection of NCI PRO-CTCAE questionnaire	Baseline through 2 year follow-up
EORTC Quality of Life Assessment	Collection of EORTC QLQ C30	Baseline through 2 year follow-up
EuroQol Quality of Life Assessment	Collection EQ-5D-5L questionnaires	Baseline through 2 year follow-up
Local Progression Free Survival	Local progression free survival	From time of inclusion to local progression, assessed up to 24 months post treatment
Local Control	Local control (freedom from local progression)	At 12 and 24 months
Progression Free Survival	Progression free survival (from time of inclusion to disease progression)	From time of inclusion to disease progression, assessed up to 24 months post treatment
Overall Survival	Overall survival	From time of inclusion to death from any cause, assessed up to 24 months post treatment
Disease Free Survival	Disease Free Survival	From time of inclusion to death from bladder cancer, assessed up to 24 months post treatment
Treatment Related Hospitalization	Hospitalization due to adaptive radiation therapy treatment related toxicity	From of start of radiation therapy through 2 year follow-up
Workflow Feasibility	Record percentage of fractions delivered with adaptive radiation therapy vs traditional IGRT	From start of radiation therapy through end of external beam treatment (approximately 6 weeks)

Collaborators and Investigators

• Sponsor: Varian, a Siemens Healthineers Company
• Collaborators: Rigshospitalet, Denmark; Herlev Hospital
• Investigators: Principal Investigator: Katrine Storm, MD, Herlev Hospital, Copenhagen University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: VAR-2021-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No