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

NCT ID: NCT07184021

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-09-30

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.

Detailed Description

Muscle-invasive bladder cancer (MIBC) poses a significant therapeutic challenge due to its high risk of progression and metastasis. Radical cystectomy remains the cornerstone of curative treatment; however, many patients relapse due to undetected micrometastases at diagnosis. To address this, neoadjuvant chemotherapy (NAC) with cisplatin-based combinations has been established as standard care, demonstrating improved pathological downstaging and survival outcomes compared to surgery alone (Yin et al., 2020; Necchi et al., 2017).

Gemcitabine and cisplatin (GC) is widely favored in NAC because of its comparable efficacy to older regimens and a more favorable toxicity profile (Galsky et al., 2016). However, conventional schedules may be limited by treatment delays and incomplete cycles, often due to cumulative toxicities or patient frailty. Dose-dense chemotherapy-delivering the same drugs at shorter intervals with growth factor support-has been proposed to improve outcomes by intensifying dose intensity and reducing tumor repopulation between cycles (Zargar et al., 2018; Kulkarni et al., 2020).

Evaluating dose-dense GC in the neoadjuvant setting aims to balance efficacy and tolerability, potentially increasing rates of complete pathological response and improving long-term survival. This protocol seeks to explore the feasibility, safety, and oncological benefit of this approach in patients with MIBC.

Conditions

Urinary Bladder Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant Dose-Dense Gemcitabine and Cisplatin (DDGC)

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.

Group Type: EXPERIMENTAL

Gemcitabine and Cisplatin (DD GC)

Intervention Type: 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.

Interventions

Gemcitabine and Cisplatin (DD GC)

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.

Intervention Type: DRUG

Eligibility Criteria

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.

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.
• Significant renal impairm ent (creatinine clearance < 60 mL/min).
• ECOG performance status ≥ 2.
• Significant comorbidities contraindicating chemotherapy (e.g., uncontrolled cardiac disease, severe infection).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Nehal Ali Suliman

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amal Rayan, Professor

Role: STUDY_DIRECTOR

Assiut University Hospitals, Faculty of medicine, Assiut University

Locations

Assiut university Hospital-Departement of clinical oncology.

Asyut, , Egypt

Countries

Egypt

Central Contacts

Nehal Suliman, Assistant lecturer

Role: CONTACT

nehal.ali95@yahoo.com

01098019919

Doaa Aly, Assistant professor

Role: CONTACT

doaaalygamaal@gmail.com

Facility Contacts

Nehal Suliman, Assistant lecturer

Role: primary

Nehal.ali95@yahoo.com

Doaa Aly, Assistant professor

Role: backup

Doaaalygamaal@gmail.com

Study Documents

Document Type: Study Protocol

Individual participant data and supporting documents will not be shared in order to protect patient confidentiality.

View Document

Related Links

https://www.aun.edu.eg/hospitals

Assiut University Hospitals

Other Identifiers

Early Urinary bladder cancer

Identifier Type: -

Identifier Source: org_study_id