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Trial Title:
Carboplatin-gemcitabine Versus Cisplatin- Gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urinary Bladder Cancer
NCT ID:
NCT05822934
Condition:
Urinary Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Carboplatin
Gemcitabine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Masking description:
Single blind study
Intervention:
Intervention type:
Drug
Intervention name:
Carboplatin-Gemcitabine Cisplatin-Gemcitabine
Description:
Carboplatin-gemcitabine versus cisplatin-gemcitabine as neoadjuvant chemotherapy for
treatment of muscle invasive urinary bladder cancer
Arm group label:
Carboplatin-gemcitabine
Arm group label:
cisplatin-gemcitabine
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
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
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AssiutU
Address:
City:
Assiut
Country:
Egypt
Start date:
November 1, 2022
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Assiut University
Agency class:
Other
Source:
Assiut University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05822934
