Neoadjuvent Dose-dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer

NCT07184021 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: Early Urinary bladder cancer
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the feasibility, safety, and pathological response of dose-dense neoadjuvant gemcitabine and cisplatin in patients with muscle-invasive bladder cancer, with the goal of improving tumor downstaging and optimizing outcomes before radical cystectomy.

Conditions

Urinary Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response (pT0N0) Rate

  Proportion of participants with no residual invasive or non-invasive tumor in the bladder and no lymph node involvement (ypT0N0) at the time of radical cystectomy, as determined by histopathological examination of the surgical specimen.

  At the time of radical cystectomy (approximately 4-6 weeks after completion of neoadjuvant chemotherapy).

Study Arms (1)

Neoadjuvant Dose-Dense Gemcitabine and Cisplatin (DDGC)

EXPERIMENTAL

Participants will receive four cycles of dose-dense gemcitabine and cisplatin (DDGC) prior to radical cystectomy. Each cycle consists of gemcitabine 1200 mg/m² intravenously on days 1 and 8, and fractionated cisplatin 35mg/m² intravenously on day 1and 8, repeated every 14 days. Pegfilgrastim 6 mg subcutaneously will be administered on day 2 of each cycle for growth factor support. Radical cystectomy will be performed 4-6 weeks after completion of chemotherapy.

Drug: Gemcitabine and Cisplatin (DD GC)

Interventions

Gemcitabine and Cisplatin (DD GC) DRUG

Participants will receive neoadjuvant ddGC, consisting of gemcitabine and cisplatin administered at shortened intervals (e.g., gemcitabine 1200 mg/m² on days 1 and 8, fractionated cisplatin 35 mg/m² on day 1and 8, every 14 days) with appropriate growth factor support. A total of four cycles are planned before radical cystectomy.

Neoadjuvant Dose-Dense Gemcitabine and Cisplatin (DDGC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed urothelial carcinoma of the bladder, clinical stage T2-T4a, N0-N1, M0.
• Eligible and fit for cisplatin-based chemotherapy (e.g., creatinine clearance ≥ 60 mL/min).
• Candidate for radical cystectomy after neoadjuvant treatment.
• ECOG performance status 0-1.
• Adequate bone marrow, liver, and renal function as per institutional standards.

You may not qualify if:

• Histology predominantly other than urothelial carcinoma (e.g., small cell, squamous cell ≥50%).
• Clinical or radiological evidence of distant metastases (M1).
• Prior systemic chemotherapy or radiotherapy for bladder cancer.
• Significant renal impairm ent (creatinine clearance \< 60 mL/min).
• ECOG performance status ≥ 2.
• Significant comorbidities contraindicating chemotherapy (e.g., uncontrolled cardiac disease, severe infection).

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university Hospital-Departement of clinical oncology.

Asyut, Egypt

Location

Related Links

• Assiut University Hospitals

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Amal Rayan, Professor

  Assiut University Hospitals, Faculty of medicine, Assiut University

  STUDY DIRECTOR

Central Study Contacts

Nehal Suliman, Assistant lecturer

CONTACT

01098019919; nehal.ali95@yahoo.com

Doaa Aly, Assistant professor

CONTACT

doaaalygamaal@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Type of Study: Prospective, single-arm, interventional study evaluating the safety, feasibility, and pathological response of dose-dense neoadjuvant gemcitabine and cisplatin in muscle-invasive bladder cancer. 2.4. 2- Study Setting: Clinical Oncology department, Assiut University Hospitals 2.4. 3- Study subjects: 1. Inclusion criteria: * Histologically confirmed urothelial carcinoma of the bladder, clinical stage T2-T4a, N0-N1, M0. * Eligible and fit for cisplatin-based chemotherapy (e.g., creatinine clearance ≥ 60 mL/min). * Candidate for radical cystectomy after neoadjuvant treatment. * ECOG performance status 0-1. * Adequate bone marrow, liver, and renal function as per institutional standards. 2. Exclusion criteria: * Histology predominantly other than urothelial carcinoma (e.g., small cell, squamous cell ≥50%). * Clinical or radiological evidence of distant metastases (M1). * Prior systemic chemotherapy or radiotherapy for bladder cancer. * Signific

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: September 19, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

EG (1)