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NCT Number: NCT05295992

Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Muscle-Invasive Bladder Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev and Gentofte Hospital

Herlev, DK-2730, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically proven bladder cancer
  • Urothelial carcinoma
  • Age ≥ 18 years
  • Stage T1b-T4AN0M0
  • TUR-B and PET-CT or CT of thorax/abdomen/pelvis within 8 weeks prior to inclusion
  • 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
  • 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

  • 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)

Treatment and study plan

Varian Ethos Adaptive Radiation Therapy

Device

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

Primary outcomes

  1. Early Rate CTCAE GI Toxicity

    Time frame: Start of radiotherapy to 3 months after end of radiotherapy

    Change of the peak early rate of external beam radiation therapy treatment-related (CTCAE) grade 2+ diarrhea

Secondary outcomes

  1. All Early CTCAE Treatment Related Toxicities

    Time frame: From start of radiotherapy through 3 months after end of radiotherapy

    All early adaptive radiation therapy treatment related CTCAE grade 2 and above toxicity

  2. All Late CTCAE Treatment Related Toxicities

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

    All late CTCAE adaptive radiation therapy treatment related toxicity grade 2 and above

  3. Patient Reported Outcomes (PRO)

    Time frame: Baseline through 2 year follow-up

    Collection of NCI PRO-CTCAE questionnaire

  4. EORTC Quality of Life Assessment

    Time frame: Baseline through 2 year follow-up

    Collection of EORTC QLQ C30

  5. EuroQol Quality of Life Assessment

    Time frame: Baseline through 2 year follow-up

    Collection EQ-5D-5L questionnaires

  6. Local Progression Free Survival

    Time frame: From time of inclusion to local progression, assessed up to 24 months post treatment

    Local progression free survival

  7. Local Control

    Time frame: At 12 and 24 months

    Local control (freedom from local progression)

  8. Progression Free Survival

    Time frame: From time of inclusion to disease progression, assessed up to 24 months post treatment

    Progression free survival (from time of inclusion to disease progression)

  9. Overall Survival

    Time frame: From time of inclusion to death from any cause, assessed up to 24 months post treatment

    Overall survival

  10. Disease Free Survival

    Time frame: From time of inclusion to death from bladder cancer, assessed up to 24 months post treatment

    Disease Free Survival

  11. Treatment Related Hospitalization

    Time frame: From of start of radiation therapy through 2 year follow-up

    Hospitalization due to adaptive radiation therapy treatment related toxicity

  12. Workflow Feasibility

    Time frame: From start of radiation therapy through end of external beam treatment (approximately 6 weeks)

    Record percentage of fractions delivered with adaptive radiation therapy vs traditional IGRT

Sponsors and collaborators

Lead sponsor

Varian, a Siemens Healthineers Company

Industry

Collaborators

  • Herlev Hospital
  • Rigshospitalet, Denmark

Registry information

Official study title

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)

Acronym: ARTIA-Vesica

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Mar 25, 2022
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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