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

Varian

Status: Enrolling

Conditions: Muscle-Invasive Bladder Carcinoma

Treatments: Device: Varian Ethos Adaptive Radiation Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05295992

VAR-2021-06

Details and patient eligibility

About

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).

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Daily Adaptive External Beam Radiation Therapy

Experimental group

Description:

Daily adaptive radiation therapy delivered with Varian Ethos treatment system.

Treatment:

Device: Varian Ethos Adaptive Radiation Therapy