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

Primary Purpose

Muscle-Invasive Bladder Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Varian Ethos Adaptive Radiation Therapy
Sponsored by
Varian, a Siemens Healthineers Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle-Invasive Bladder Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Herlev and Gentofte HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Daily Adaptive External Beam Radiation Therapy

Arm Description

Daily adaptive radiation therapy delivered with Varian Ethos treatment system.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

All Early CTCAE Treatment Related Toxicities
All early adaptive radiation therapy treatment related CTCAE grade 2 and above toxicity
All Late CTCAE Treatment Related Toxicities
All late CTCAE adaptive radiation therapy treatment related toxicity grade 2 and above
Patient Reported Outcomes (PRO)
Collection of NCI PRO-CTCAE questionnaire
EORTC Quality of Life Assessment
Collection of EORTC QLQ C30
EuroQol Quality of Life Assessment
Collection EQ-5D-5L questionnaires
Local Progression Free Survival
Local progression free survival
Local Control
Local control (freedom from local progression)
Progression Free Survival
Progression free survival (from time of inclusion to disease progression)
Overall Survival
Overall survival
Disease Free Survival
Disease Free Survival
Treatment Related Hospitalization
Hospitalization due to adaptive radiation therapy treatment related toxicity
Workflow Feasibility
Record percentage of fractions delivered with adaptive radiation therapy vs traditional IGRT

Full Information

First Posted
March 4, 2022
Last Updated
March 12, 2023
Sponsor
Varian, a Siemens Healthineers Company
Collaborators
Herlev Hospital, Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05295992
Brief Title
Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Varian, a Siemens Healthineers Company
Collaborators
Herlev Hospital, Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle-Invasive Bladder Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Daily Adaptive External Beam Radiation Therapy
Arm Type
Experimental
Arm Description
Daily adaptive radiation therapy delivered with Varian Ethos treatment system.
Intervention Type
Device
Intervention Name(s)
Varian Ethos Adaptive Radiation Therapy
Intervention Description
Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.
Primary Outcome Measure Information:
Title
Early Rate CTCAE GI Toxicity
Description
Change of the peak early rate of external beam radiation therapy treatment-related (CTCAE) grade 2+ diarrhea
Time Frame
Start of radiotherapy to 3 months after end of radiotherapy
Secondary Outcome Measure Information:
Title
All Early CTCAE Treatment Related Toxicities
Description
All early adaptive radiation therapy treatment related CTCAE grade 2 and above toxicity
Time Frame
From start of radiotherapy through 3 months after end of radiotherapy
Title
All Late CTCAE Treatment Related Toxicities
Description
All late CTCAE adaptive radiation therapy treatment related toxicity grade 2 and above
Time Frame
From 3 months after end of radiotherapy through 2 years follow-up
Title
Patient Reported Outcomes (PRO)
Description
Collection of NCI PRO-CTCAE questionnaire
Time Frame
Baseline through 2 year follow-up
Title
EORTC Quality of Life Assessment
Description
Collection of EORTC QLQ C30
Time Frame
Baseline through 2 year follow-up
Title
EuroQol Quality of Life Assessment
Description
Collection EQ-5D-5L questionnaires
Time Frame
Baseline through 2 year follow-up
Title
Local Progression Free Survival
Description
Local progression free survival
Time Frame
From time of inclusion to local progression, assessed up to 24 months post treatment
Title
Local Control
Description
Local control (freedom from local progression)
Time Frame
At 12 and 24 months
Title
Progression Free Survival
Description
Progression free survival (from time of inclusion to disease progression)
Time Frame
From time of inclusion to disease progression, assessed up to 24 months post treatment
Title
Overall Survival
Description
Overall survival
Time Frame
From time of inclusion to death from any cause, assessed up to 24 months post treatment
Title
Disease Free Survival
Description
Disease Free Survival
Time Frame
From time of inclusion to death from bladder cancer, assessed up to 24 months post treatment
Title
Treatment Related Hospitalization
Description
Hospitalization due to adaptive radiation therapy treatment related toxicity
Time Frame
From of start of radiation therapy through 2 year follow-up
Title
Workflow Feasibility
Description
Record percentage of fractions delivered with adaptive radiation therapy vs traditional IGRT
Time Frame
From start of radiation therapy through end of external beam treatment (approximately 6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steve Kohlmyer, MS
Phone
12062760076
Email
steve.kohlmyer@varian.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sean Davidson, MS
Email
sean.davidson@varian.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrine Storm, MD
Organizational Affiliation
Herlev Hospital, Copenhagen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev and Gentofte Hospital
City
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrine Storm
Email
katrine.smedegaard.storm@regionh.dk

12. IPD Sharing Statement

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Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach

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