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NORTH-REG Dwell-Time Study

Primary Purpose

Side Effect of Drug

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Bacillus Calmette Guerin
Sponsored by
Jørgen Bjerggaard Jensen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Side Effect of Drug

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ≥18 years of age at the time of signing the Informed Consent Form
  • Signed Informed Consent Form
  • Patients with NMIBC where BCG therapy including maintenance for 1 year is planned for one of the following histopathological findings:
  • Ta high grade without CIS
  • CIS with or without previous or concomitant Ta tumors
  • T1 with or without CIS
  • Is, according to the Investigator's judgement, able to comply with the trial protocol
  • Ability to understand the Patient Information Sheet orally and in writing

Exclusion Criteria:

  • Previous BCG instillations
  • T1 tumors where re-resection had not been performed
  • TUR-B, bladder biopsy or traumatic catheterization within 2 weeks.
  • Previous or current MIBC
  • Previous or current metastatic urothelial carcinoma
  • Contraindications to BCG
  • Incontinence
  • Need for catheter a demeure at the time of instillation
  • Immune Suppressing medication (cancer therapy e.g cytostatic medicinal products, radiation, local and systemic steroids like e.g. prednisolone is permitted)
  • Reduced immune response (leukaemia, lymphoma)
  • Known allergy or sensitivity to BCG
  • HIV infection
  • Signs of active tuberculosis
  • Previously radiation therapy of the bladder
  • Known with another cancer diagnosis, except prostate cancer
  • Current urinary tract infection
  • Patient with visible hematuria
  • Current alcohol and/or drug abuse
  • Has a mental or legal incapacitation or another condition which impair the subject's ability to participate
  • Has participated in another interventional clinical study and treatment with another investigational product 30 days prior to randomization
  • For women study subjects: Pregnancy or breastfeeding
  • For women Study subjects of childbearing potential: unless they are using highly effective methods of contraception from the first BCG instillations until 14 days after last dose of BCG treatment, which are defined as total abstinence, female sterilization, use of oral methods of contraception or placement of an intrauterine contraception devices.
  • For male Study Subjects: unless they are using highly effective methods of contraception from the first BCG instillation until for 14 days after last dose of BCG treatment, which is defined as total abstinence or use of condoms.

Sites / Locations

  • Aarhus University HospitalRecruiting
  • Department of Urology, Aalborg University HospitalRecruiting
  • Herlev HospitalRecruiting
  • Regional Hospital GødstrupRecruiting
  • Department of Urology, Rigshospitalet
  • Odense University HospitalRecruiting
  • Zealand University HospitalRecruiting
  • Landspitali University HospitalRecruiting
  • PO Sahlgrenska UniversitetssjukhusetRecruiting
  • Karolinska University HospitalRecruiting
  • Örebro University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Study Subjects randomized to the interventional arm will be assigned to BCG induction therapy once-weekly for 6 weeks and subsequent 1 year of maintenance (6+3x3) of which dwell-time during the first of the 6 induction instillations is 2 hours. If side effects are registered before the second and all further instillations, Study Subject in the intervention arm will be reduced in dwell-time according to the grading of side effects as given by the study algorithm.

The Study Subjects will be treated according to guidelines with BCG instillation therapy once weekly for 6 weeks and subsequent 1 year of maintenance therapy (6+3x3) with 2 hours of dwelltime.

Outcomes

Primary Outcome Measures

Completion of instillations
Number of Study Subjects completing all 6 induction instillations and subsequent maintenance installations for 12 months (6 + 3 x 3)

Secondary Outcome Measures

Recurrence rate
Recurrence rate within 24 months in Study Subjects with initial complete response

Full Information

First Posted
January 6, 2021
Last Updated
April 28, 2023
Sponsor
Jørgen Bjerggaard Jensen
Collaborators
Aarhus University Hospital, Herlev Hospital, Odense University Hospital, Aalborg University Hospital, Regional Hospital West Jutland, Rigshospitalet, Denmark, Zealand University Hospital, Landspitali University Hospital, Sahlgrenska University Hospital, Sweden, Region Örebro County, Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04701151
Brief Title
NORTH-REG Dwell-Time Study
Official Title
Nordic Urothelial Cancer Research Group Study on Reduced BCG Dwell-Time in High Risk NMIBC
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jørgen Bjerggaard Jensen
Collaborators
Aarhus University Hospital, Herlev Hospital, Odense University Hospital, Aalborg University Hospital, Regional Hospital West Jutland, Rigshospitalet, Denmark, Zealand University Hospital, Landspitali University Hospital, Sahlgrenska University Hospital, Sweden, Region Örebro County, Karolinska University Hospital

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
Yes

5. Study Description

Brief Summary
Previous studies show that the majority NMIBC patients experience side effects to BCG and therefore terminate the instillations before completing all planned instillations. This will increase their risk of recurrence and potential cystectomy. The purpose of this study is to investigate if NMIBC patients who experience severe side effects to BCG instillations will experience fewer or less severe side effects if reducing dwell-time of BCG instillations. The study will include patients from Denmark, Iceland, Norway and Sweden.
Detailed Description
Approximately 8,000 patients are diagnosed with bladder cancer (BC) in the Nordic countries every year. The majority of BC patients are diagnosed with non-muscle invasive bladder cancer (NMIBC). The majority of NMIBC are treated with Bacillus Calmette-Guérin vaccine (BCG) as adjuvant treatment but for carcinoma in situ it is the primary treatment. BCG is known to give a lot of side effects both local and systemic, the severity of these can lead to premature termination of the treatment. The object of this PhD project is to investigate if reduced dwell time, the time the BCG is in the bladder, will decrease the severity of side effects due to BCG instillations. This will be investigated in a Nordic setting and the project will be done as a two-armed randomized clinical trial. By decreasing the severity of side effects, we hypothesize the number of patients completing all planned instillations will increase and thereby decrease the risk of the BC evolving into a more aggressive type.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Side Effect of Drug

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
multi-center, multi-national, two-armed, randomized, open-label, investigator-initiated clinical controlled - phase IV trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
314 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Study Subjects randomized to the interventional arm will be assigned to BCG induction therapy once-weekly for 6 weeks and subsequent 1 year of maintenance (6+3x3) of which dwell-time during the first of the 6 induction instillations is 2 hours. If side effects are registered before the second and all further instillations, Study Subject in the intervention arm will be reduced in dwell-time according to the grading of side effects as given by the study algorithm.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The Study Subjects will be treated according to guidelines with BCG instillation therapy once weekly for 6 weeks and subsequent 1 year of maintenance therapy (6+3x3) with 2 hours of dwelltime.
Intervention Type
Drug
Intervention Name(s)
Bacillus Calmette Guerin
Intervention Description
The same dose of the drug will be given in both arms but the dwell-time will be adjusted for the subjects in the intervention arm according to the grading of side effects given by the study algorithm.
Primary Outcome Measure Information:
Title
Completion of instillations
Description
Number of Study Subjects completing all 6 induction instillations and subsequent maintenance installations for 12 months (6 + 3 x 3)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Recurrence rate
Description
Recurrence rate within 24 months in Study Subjects with initial complete response
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ≥18 years of age at the time of signing the Informed Consent Form Signed Informed Consent Form Patients with NMIBC where BCG therapy including maintenance for 1 year is planned for one of the following histopathological findings: Ta high grade without CIS CIS with or without previous or concomitant Ta tumors T1 with or without CIS Is, according to the Investigator's judgement, able to comply with the trial protocol Ability to understand the Patient Information Sheet orally and in writing Exclusion Criteria: Previous BCG instillations within the last 2 years, because of the risk of not having cleared potential previos side effects. T1 tumors where re-resection had not been performed TUR-B, bladder biopsy or traumatic catheterization within 2 weeks. Previous or current MIBC Progression defined as progrssion to T1-tumour, T2+_tumour or cystectomy irrespectievely of indication or development of metastatic urothelial cancer irrespectively of tumour stage Contraindications to BCG Incontinence Bilateral nephrostomy catheters; unilateral nephrostomy catheter is allowed if permanent for the duration of all inistallations with BCG and a normally functioning kidney. Need for catheter a demeure at the time of instillation Immune Suppressing medication (cancer therapy e.g cytostatic medicinal products, radiation, local and systemic steroids like e.g. prednisolone is permitted) Reduced immune response (leukaemia, lymphoma) Known allergy or sensitivity to BCG HIV infection Signs of active tuberculosis Any type of previosly radiation therapy involving the bladder. Concomitant invasive cancer within 5 years other than non-melanoma skin cancer and protate cancer without metastasis Current urinary tract infection Patient with visible hematuria Current alcohol and/or drug abuse Has a mental or legal incapacitation or another condition which impair the subject's ability to participate Has participated in another interventional clinical study and treatment with another investigational product 30 days prior to randomization For women study subjects: Pregnancy or breastfeeding For women Study subjects of childbearing potential: unless they are using highly effective methods of contraception from the first BCG instillations until 14 days after last dose of BCG treatment, which are defined as total abstinence, female sterilization, use of oral methods of contraception or placement of an intrauterine contraception devices. For male Study Subjects: unless they are using highly effective methods of contraception from the first BCG instillation until for 14 days after last dose of BCG treatment, which is defined as total abstinence or use of condoms.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jørgen B. Jensen, Professor,DMSc
Phone
+45 78452617
Email
Bjerggaard@skejby.rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lene Munk, MD
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
State/Province
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lene Munk, MD
Facility Name
Department of Urology, Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Knud Fabrin, MD
Facility Name
Herlev Hospital
City
Herlev
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gitte Lam, MD
Facility Name
Regional Hospital Gødstrup
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Hansen, MD
Facility Name
Department of Urology, Rigshospitalet
City
København
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulla Nordström Joensen, MD, PhD Assoc. Professor
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lasse Bro, MD
Facility Name
Zealand University Hospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Luis Vásquez, MD
Facility Name
Landspitali University Hospital
City
Reykjavík
ZIP/Postal Code
101
Country
Iceland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigurdur Gudjonsson
Facility Name
PO Sahlgrenska Universitetssjukhuset
City
Göteborg
ZIP/Postal Code
sw 413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viveka Ströck, MD
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
141-86
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomas Thiel, MD
Facility Name
Örebro University Hospital
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomas Jerlsström

12. IPD Sharing Statement

Plan to Share IPD
No

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NORTH-REG Dwell-Time Study

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