Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorCase Comprehensive Cancer Center
About this trial
The goal of this clinical trial is to determine if a partial cystectomy with extended pelvic lymph node removal will be effective at treating Muscle-Invasive Bladder Cancer instead of a complete cystectomy with extended pelvic lymph node removal. This clinical trial aims to determine the safety and oncologic efficacy of the intervention, and to examine patient-reported quality of life outcomes in participants. Participants will receive the standard pre-surgery treatment for approximately 4 to 6 weeks. After the pre-surgery treatment is completed, participants will undergo a partial cystectomy with extended pelvic lymph node dissection. After surgery, participants will receive adjuvant systemic therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects must have histologically confirmed urothelial carcinoma of the bladder, clinical stage T2-3N0M0. Micropapillary, glandular, squamous, and sarcomatoid histologic variants of urothelial carcinoma are allowed.
Subjects must have unifocal or limited multifocal disease amenable to complete surgical resection with partial cystectomy, as judged by the treating urologic oncologist.
Age >18 years. Because of the rarity of this disease and limited data on treatment efficacy in subjects 18 years of age, children are excluded from this study.
Performance status - Karnofsky Performance Status ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1.
Disqualifiers
Presence of hydronephrosis.
Presence of multifocal disease that is not amenable to complete resection with partial cystectomy.
Presence of distant carcinoma in situ.
Presence of clinical N+ or M+ disease.
Trial design
Design model
Parallel
Treatments tested in this trial
Neoadjuvant Chemotherapy
DrugStandard of care neoadjuvant systemic therapy is currently cisplatin-based chemotherapy in cisplatin-eligible participants. Participants will start treatment within 60 days of Transurethral Resection of Bladder Tumor. Regimens may include: * Cisplatin - Gemcitabine (Gem/Cis) * Dose Dense Methotrexate - Vinblastine - Adriamycin - Cisplatin (MVAC)
Partial cystectomy with Extended pelvic lymph node dissection
Procedure/SurgeryPartial cystectomy will then be performed using the surgical technique at the discretion of the treating Urologic Oncologist. Extended pelvic lymphadenectomy will then be performed at the discretion of the treating Urologic Oncologist. Surgery will be performed within 60 days of Transurethral Resection of Bladder Tumor for Cisplatin-ineligible participants. Surgery will be performed within 60 days of completing neoadjuvant chemotherapy for Cisplatin-eligible participants.
Adjuvant systemic therapy
DrugStandard of care adjuvant systemic therapy in eligible participants. The choice of adjuvant systemic therapy will be left to the discretion of the treating Medical Oncologist but must fall within the SOC as outlined in NCCN guidelines.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Cisplatin Eligible ParticipantsExperimental treatment 3 interventions
Group B: Cisplatin Ineligible ParticipantsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Recurrence-Free Survival (RFS)
Recurrence-Free Survival (RFS) is defined as the time from post-surgery baseline scan (revealing no recurrent/metastatic disease) until the first occurrence of either local or distant recurrence as assessed by CT or MRI and/or biopsy. The primary outcome of distant RFS will be assessed via Kaplan-Meier analysis
Time frame
Up to 24 months from date of post-surgery baseline scanSecondary outcomes
1
Presence of Post-operative Complications
The Clavien-Dindo classification will measure post-operative complications. The Clavien-Dindo Classification of Post-operative Complications is a tool to assess complications following surgical treatment. This tool ranks complications on a scale of seven levels, with level 1 being the least complicated and 7 being the worst complication resulting in death. The average classification at 90 days will be assessed and reported.
Time frame
At 90 days after surgery2
Median Bladder RFS
The median duration of bladder recurrence-free survival at 2 years.
Time frame
Up to 24 months from date of post-surgery baseline scan3
Median Muscle-Invasive Bladder RFS
The median duration of muscle-invasive bladder recurrence-free survival at 2 years.
Time frame
Up to 24 months from date of post-surgery baseline scan4
Median Bladder-Intact Survival
The median duration of bladder-intact survival at 2 years.
Time frame
Up to 24 months from date of post-surgery baseline scanSponsors and contacts
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Source ClinicalTrials.gov