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Active, Not Recruiting

NCT Number: NCT05822934

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carboplatin-Gemcitabine Cisplatin-Gemcitabine

Drug

Carboplatin-gemcitabine versus cisplatin-gemcitabine as neoadjuvant chemotherapy for treatment of muscle invasive urinary bladder cancer

Primary outcomes

  1. Clinical response rate

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Carboplatin-gemcitabine Versus Cisplatin-gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urinary Bladder Cancer: a Prospective Randomized Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 21, 2023
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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