ISRCTN17378733
Active, not recruiting
Phase 2
GUSTO: Gene expression subtypes of Urothelial cancer: Stratified Treatment and Oncological outcomes
Sheffield Teaching Hospitals NHS Foundation Trust0 sites320 target enrollmentStarted: April 27, 2023Last updated:
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 320
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Inclusion criteria for registration:
- •1\. Age \=18 years
- •2\. Eastern Co\-operative Oncology Group (ECOG) performance status 0 or 1
- •3\. Currently considered for neoadjuvant chemotherapy and radical cystectomy with curative intent and suitable for all protocol defined treatment (chemotherapy and immunotherapy as defined for all treatment groups in this protocol)
- •4\. Histological confirmation of MIBC with pure or mixed urothelial (transitional) cell carcinoma (full report not required)
- •5\. Written informed consent for registration (PIS\-1 and Participant Supplementary Document)
- •Inclusion criteria for randomisation:
- •1\. Diagnosed with MIBC staged as either T2\-4a N0 M0 or T (any) N1 M0
- •2\. Planned for neoadjuvant chemotherapy and radical cystectomy with curative intent and suitable for all protocol defined treatment (chemotherapy and immunotherapy as defined for all treatment groups in the protocol)
- •3\. Confirmation of a pure or mixed urothelial (transitional cell) carcinoma tumour histology based on local institutional pathology reporting
Exclusion Criteria
- •1\. Bladder tumour where a gene expression subtype classification cannot be made
- •2\.TURBT sample processing delay such that \>4 weeks from receipt of TURBT sample at central lab to receipt of gene expression subtype result at site
- •3\. Known or suspected allergy or hypersensitivity reaction to any of the components of study treatment or their excipients for any of the treatment groups in the protocol
- •4\. Active infection likely to impact safety of treatment delivery for any of the study treatment groups in the protocol or radical cystectomy. This includes known active tuberculosis, hepatitis B (known positive HBsAg result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti\-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid
- •5\. Active documented autoimmune or inflammatory disorders, including but not limited to, inflammatory bowel disease (e.g., colitis or Crohn’s disease), systemic lupus erythematosus, sarcoidosis, Wegener syndrome (granulomatosis with polyangiitis), Graves’ disease, rheumatoid arthritis and uveitis. Exceptions: vitiligo, alopecia, hypothyroidism that is stable on hormone replacement and any chronic skin condition not requiring systemic therapy
- •6\. Major surgical procedure \<28 days prior to randomisation
- •7\. Coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable angina pectoris or congestive cardiac failure (New York Heart Association \> grade 2\) within the last 6 months
- •8\. Mean QT interval corrected for heart rate \=470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart)
- •9\. Uncontrolled concurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise ability of the
- •patient to give written informed consent
Investigators
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