Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach

Not Applicable

Recruiting

• Conditions: Muscle-Invasive Bladder Carcinoma
• Interventions: Device: Varian Ethos Adaptive Radiation Therapy

• Registration Number: NCT05295992
• Lead Sponsor: Varian, a Siemens Healthineers Company

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-04
• Study Start: 2022-03-15
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-25
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-12
• Last Update Posted: 2023-03-14
• Primary Completion: 2024-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Daily Adaptive External Beam Radiation Therapy	Varian Ethos Adaptive Radiation Therapy	Daily adaptive radiation therapy delivered with Varian Ethos treatment system.

Primary Outcome Measures

Name	Time	Method
Early Rate CTCAE GI Toxicity	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 Outcome Measures

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

Trial Locations

Locations (1)

Herlev and Gentofte Hospital; 🇩🇰 Herlev, Denmark