Clinical trial · Interventional

Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy

Phase II Trial on the Safety and Efficacy of Partial Cystectomy and Extended Pelvic Lymph Node Dissection With Standard of Care Perioperative Systemic Therapy in the Management of Muscle-Invasive Bladder Cancer (PRESERVE Trial)

NCT06290687CI-TRIAL-00120937withdrawnPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): PI left institution

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Malignant Neoplasm of Bladder	Malignant Bladder Neoplasm	ALIAS	0.90
Muscle Invasive Bladder Carcinoma	Muscle Invasive Bladder Carcinoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Adjuvant systemic therapy	Drug	—	UNRESOLVED
Neoadjuvant Chemotherapy	Drug	—	UNRESOLVED
Partial cystectomy with Extended pelvic lymph node dissection	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Cisplatin Eligible Participants
description
Participants who are deemed eligible for cisplatin-based NAC will undergo: * Standard of care neoadjuvant systemic therapy (currently cisplatin-based chemotherapy in cisplatin-eligible participants) * Partial cystectomy with extended pelvic lymph node dissection * Standard of care adjuvant systemic therapy in eligible patients
interventionNames
1. Drug: Neoadjuvant Chemotherapy
2. Procedure: Partial cystectomy with Extended pelvic lymph node dissection
3. Drug: Adjuvant systemic therapy
type
EXPERIMENTAL
label
Cisplatin Ineligible Participants
description
Participants who are deemed ineligible for cisplatin-based NAC will undergo: * Partial cystectomy with extended pelvic lymph node dissection * Standard of care adjuvant systemic therapy in eligible participants
interventionNames
1. Procedure: Partial cystectomy with Extended pelvic lymph node dissection

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 19 Years

Show eligibility criteria text

Inclusion Criteria:

* 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.
* Subjects must have normal organ and marrow function as defined below:

* Total bilirubin within normal limits
* AST (SGOT) ≤ 2.5 X institutional upper limit of normal
* ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
* Bone marrow:

* Absolute neutrophil count (ANC) ≥ 1,500/mm3
* Platelet count ≥ 80,000/mm3, Hemoglobin ≥ 9.0 g/dL
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.
* Subjects must have tumor less than or equal to 5 cm in largest dimension as assessed radiographically.
* Treatment naive for MIBC.

Exclusion Criteria:

* 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.
* Presence of cT4+ disease.
* Non-urothelial histology.
* Concurrent upper tract (ureter or renal pelvis) or urethral urothelial carcinoma.
* Subjects who are not surgical candidates due to competing medical comorbidities or who refuse surgical treatment.
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

References

Publications (0)

Data not yet available

No reference posted for this study.