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

Assiut University

Status and phase: Active, not recruiting; Phase 3

Conditions: Urinary Bladder Cancer

Treatments: Drug: Carboplatin-Gemcitabine Cisplatin-Gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT05822934

Urinary bladder cancer

Details and patient eligibility

About

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

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

Carboplatin-gemcitabine

Experimental group

Description:

3-4 cycles of Carboplatin-Gemcitabine as a neoadjuvant treatment for Urinary bladder cancer Muscle invasive

Treatment:

Drug: Carboplatin-Gemcitabine Cisplatin-Gemcitabine

cisplatin-gemcitabine

Active Comparator group

Description:

3-4 cycles of Cisplatin -Gemcitabine as a neoadjuvant treatment for Urinary bladder cancer Muscle invasive

Treatment:

Drug: Carboplatin-Gemcitabine Cisplatin-Gemcitabine