NCT05295992

Brief Summary

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Mar 2022Mar 2027

First Submitted

Initial submission to the registry

March 4, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

4.7 years

First QC Date

March 4, 2022

Last Update Submit

March 4, 2026

Conditions

Muscle-Invasive Bladder Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • All Early CTCAE Treatment Related Toxicities

    From start of radiotherapy through 3 months after end of radiotherapy

  • All Late CTCAE Treatment Related Toxicities

    From 3 months after end of radiotherapy through 2 years follow-up

  • Patient Reported Outcomes (PRO)

    Baseline through 2 year follow-up

  • EORTC Quality of Life Assessment

    Baseline through 2 year follow-up

  • EuroQol Quality of Life Assessment

    Baseline through 2 year follow-up

  • +7 more secondary outcomes

Study Arms (1)

Daily Adaptive External Beam Radiation Therapy

EXPERIMENTAL

Daily adaptive radiation therapy delivered with Varian Ethos treatment system.

Device: Varian Ethos Adaptive Radiation Therapy

Interventions

Varian Ethos Adaptive Radiation TherapyDEVICE

Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.

Daily Adaptive External Beam Radiation Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven bladder cancer
  • Urothelial carcinoma
  • Age ≥ 18 years
  • Stage T1b-T4AN0M0
  • Suitable for radiotherapy
  • ECOG/WHO performance status 0-2
  • Written informed consent
  • 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
  • +2 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev and Gentofte Hospital

Herlev, DK-2730, Denmark

Location

Study Officials

  • Katrine Storm, MD

    Herlev Hospital, Copenhagen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2022

First Posted

March 25, 2022

Study Start

March 15, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

March 6, 2026

Record last verified: 2026-03

Locations

DK(1)