NORTH-REG Dwell-Time Study
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| ClinicalTrials.gov Identifier: NCT04701151 |
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Recruitment Status :
Recruiting
First Posted : January 8, 2021
Last Update Posted : August 8, 2022
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Side Effect of Drug | Drug: Bacillus Calmette Guerin | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 314 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | multi-center, multi-national, two-armed, randomized, open-label, investigator-initiated clinical controlled - phase IV trial. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Nordic Urothelial Cancer Research Group Study on Reduced BCG Dwell-Time in High Risk NMIBC |
| Actual Study Start Date : | February 3, 2021 |
| Estimated Primary Completion Date : | February 2024 |
| Estimated Study Completion Date : | November 2026 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intervention
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. |
Drug: Bacillus Calmette Guerin
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. |
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Active Comparator: Control
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.
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Drug: Bacillus Calmette Guerin
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. |
- Completion of instillations [ Time Frame: 5 years ]Number of Study Subjects completing all 6 induction instillations and subsequent maintenance installations for 12 months (6 + 3 x 3)
- Recurrence rate [ Time Frame: 5 years ]Recurrence rate within 24 months in Study Subjects with initial complete response
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04701151
| Contact: Jørgen B. Jensen, Professor,DMSc | +45 78452617 | Bjerggaard@skejby.rm.dk | |
| Contact: Lene Munk, MD |
| Denmark | |
| Aarhus University Hospital | Recruiting |
| Aarhus, Aarhus N, Denmark, 8200 | |
| Contact: Lene Munk, MD | |
| Department of Urology, Aalborg University Hospital | Not yet recruiting |
| Aalborg, Denmark, 9100 | |
| Contact: Knud Fabrin, MD | |
| Herlev Hospital | Not yet recruiting |
| Herlev, Denmark | |
| Contact: Gitte Lam, MD | |
| Regional Hospital West Jutland | Not yet recruiting |
| Holstebro, Denmark, 7500 | |
| Contact: Erik Hansen, MD | |
| Department of Urology, Rigshospitalet | Not yet recruiting |
| København, Denmark, 2100 | |
| Contact: Ulla Nordström Joensen, MD, PhD Assoc. Professor | |
| Odense University Hospital | Not yet recruiting |
| Odense, Denmark, 5000 | |
| Contact: Lasse Bro, MD | |
| Zealand University Hospital | Not yet recruiting |
| Roskilde, Denmark, 4000 | |
| Contact: Juan Luis Vásquez, MD | |
| Iceland | |
| Landspitali University Hospital | Not yet recruiting |
| Reykjavík, Iceland, 101 | |
| Contact: Sigurdur Gudjonsson | |
| Norway | |
| Vestfold Hospital | Not yet recruiting |
| Tønsberg, Norway, NO-3116 | |
| Contact: Erik Skaaheim Haug | |
| Sweden | |
| PO Sahlgrenska Universitetssjukhuset | Not yet recruiting |
| Göteborg, Sweden, sw 413 45 | |
| Contact: Viveka Ströck, MD | |
| Örebro University Hospital | Not yet recruiting |
| Örebro, Sweden, 701 85 | |
| Contact: Tomas Jerlsström | |
| Responsible Party: | Jørgen Bjerggaard Jensen, Professor, Consultant, MD, DMSc Department of Clinical Medicine, Aarhus University, Aarhus University Hospital |
| ClinicalTrials.gov Identifier: | NCT04701151 |
| Other Study ID Numbers: |
2020-003112-27 |
| First Posted: | January 8, 2021 Key Record Dates |
| Last Update Posted: | August 8, 2022 |
| Last Verified: | August 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
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Drug-Related Side Effects and Adverse Reactions Chemically-Induced Disorders BCG Vaccine |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |