Carboplatin-gemcitabine Versus Cisplatin- Gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urinary Bladder Cancer

• Sponsor: Assiut University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05822934
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13.9
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

Patients will be randomized in 1:1 ratio to two treatment groups first group will receive 3-4 cycles of neoadjuvant Carboplatin(AUC4)-Gemcitabine (treatment group) and second group will receive 3-4 cycles of neoadjuvant Cisplatin(75mg/m2 Day1)-Gemcitabine (Control group). Patients will undergo radiological assessment, full laboratory work up, and cystoscopy before undergoing either radical cystectomy or Definitive Radiotherapy concurrent with chemotherapy

Condition or Disease	Intervention/Treatment	Phase
Urinary Bladder Cancer	Drug: Carboplatin-Gemcitabine Cisplatin-Gemcitabine	Phase 3

Detailed Description

Patients will be randomized in 1:1 ratio to two treatment groups first group will receive 3-4 cycles of neoadjuvant Carboplatin(AUC4)-Gemcitabine (treatment group) and second group will receive 3-4 cycles of neoadjuvant Cisplatin(75mg/m2 Day1)-Gemcitabine (Control group). Patients will undergo radiological assessment, full laboratory work up, and cystoscopy before undergoing either radical cystectomy or Definitive Radiotherapy concurrent with chemotherapy. After finishing treatment, all patients should undergo follow up every 3 months for two years then six monthly thereafter .Follow up will include History, physical examination, full laboratory works (CBC, renal function testing and liver function testing). Imaging by CT or MRI abdomen and pelvis for all patients and cystoscopy in bladder preservation protocol

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: Single blind study
• Primary Purpose: Treatment
• Official Title: Carboplatin-gemcitabine Versus Cisplatin-gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urinary Bladder Cancer: a Prospective Randomized Trial
• Actual Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Dec 30, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Carboplatin-gemcitabine 3-4 cycles of Carboplatin-Gemcitabine as a neoadjuvant treatment for Urinary bladder cancer Muscle invasive	Drug: Carboplatin-Gemcitabine Cisplatin-Gemcitabine; Carboplatin-gemcitabine versus cisplatin-gemcitabine as neoadjuvant chemotherapy for treatment of muscle invasive urinary bladder cancer
Active Comparator: cisplatin-gemcitabine 3-4 cycles of Cisplatin -Gemcitabine as a neoadjuvant treatment for Urinary bladder cancer Muscle invasive	Drug: Carboplatin-Gemcitabine Cisplatin-Gemcitabine; Carboplatin-gemcitabine versus cisplatin-gemcitabine as neoadjuvant chemotherapy for treatment of muscle invasive urinary bladder cancer

Outcome Measures

Primary Outcome Measures

1. Clinical response rate [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:All patients diagnosed with muscle invasive urinary bladder cancer that can receive chemotherapy are included the criteria are

• • Age above 18 years,

• Pathologically proven urinary bladder cancer,

• Patients with clinical stages T2-4a N0-3 M0,

• Patients with good renal and liver functions

• patients with no distant metastases,

• no other malignancy (double malignancy).

• Performance status 0-1 according to ECOG performance status scale.

• Patients with no contraindications for radiotherapy.

Exclusion Criteria:

• • performance status 2-4 according to ECOG performance status scale.

• patients refuse to receive chemotherapy,

• patients not eligible to receive chemotherapy due to liver or renal impairment or thrombocytopenia,

• patients with M1 disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AssiutU	Assiut		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Mohamed Mahmoud Moustafa Abdelakher, Doctor principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT05822934
• Other Study ID Numbers: Urinary bladder cancer
• First Posted: Apr 21, 2023
• Last Update Posted: Apr 25, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Gemcitabine; Carboplatin

Study Results

No Results Posted as of Apr 25, 2023