Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach

Muscle-Invasive Bladder Carcinoma Clinical Trial

— ARTIA-Vesica  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05295992
• Other study ID #: VAR-2021-06
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: March 2026

Study information

• Verified date: March 2023
• Source: Varian, a Siemens Healthineers Company
• Contact: Steve Kohlmyer, MS
• Phone: 12062760076
• Email: steve.kohlmyer[@]varian.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 2026
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Muscle-Invasive Bladder Carcinoma
• Urinary Bladder Neoplasms

Intervention

Device:
• Varian Ethos Adaptive Radiation Therapy
Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.

Locations

Country	Name	City	State
Denmark	Herlev and Gentofte Hospital	Herlev

Sponsors (3)

Lead Sponsor	Collaborator
Varian, a Siemens Healthineers Company	Herlev Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Patient Reported Outcomes (PRO)	Collection of NCI PRO-CTCAE questionnaire	Baseline through 2 year follow-up
Secondary	EORTC Quality of Life Assessment	Collection of EORTC QLQ C30	Baseline through 2 year follow-up
Secondary	EuroQol Quality of Life Assessment	Collection EQ-5D-5L questionnaires	Baseline through 2 year follow-up
Secondary	Local Progression Free Survival	Local progression free survival	From time of inclusion to local progression, assessed up to 24 months post treatment
Secondary	Local Control	Local control (freedom from local progression)	At 12 and 24 months
Secondary	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
Secondary	Overall Survival	Overall survival	From time of inclusion to death from any cause, assessed up to 24 months post treatment
Secondary	Disease Free Survival	Disease Free Survival	From time of inclusion to death from bladder cancer, assessed up to 24 months post treatment
Secondary	Treatment Related Hospitalization	Hospitalization due to adaptive radiation therapy treatment related toxicity	From of start of radiation therapy through 2 year follow-up
Secondary	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)