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Survival Benefits of Neoadjuvant Systemic Chemotherapy in Muscle Invasive Bladder Cancer

ConditionBladder Urothelial Carcinoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSara Mahmoud Ahmed Mahmoud

About this trial

Muscle-invasive bladder cancer (MIBC) is an aggressive disease with a high-risk of early metastasis and cancer specific mortality. The gold standard treatment of MIBC is radical cystectomy (RC) in conjunction with concomitant bilateral pelvic lymphadenectomy . While radical cystectomy remains a primary management strategy for MIBC, high rates of recurrence with surgery alone highlight the likelihood of occult micrometastatic disease at the time of diagnosis. Due to the development and implementation of neoadjuvant chemotherapy prior to radical cystectomy, the prognosis for MIBC patients undergoing radical cystectomy has improved .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18

histological proven MIBC patient treated with neoadjuvant systemic chemotherapy( platinum based )

Disqualifiers

Non muscle invasive bladder cancer (NMIBC)

Metastatic patients

Patients treated with surgery firstly

Trial population

Data Record of the patients will be reviewed for the following : \*Clinical features:Age , Sex , Smoking ,base line renal function , comorbidities \*HistoPathological features: Histological type of bladder cancer ,Carcinoma in situ,Lymphovascular invasion ( LVI) * Type of neoadjuvant chemotherapy received: Platinum based ( cisplatin, carboplatin) * Number of cycles . * Response to neoadjuvant chemotherapy : Assesed by radiological tools ( MRI , CT ) according to Recist criteria. * Follow up after finishing the course of neoadjuvant chemotherapy , using imaging and examination to detect the response and survival outcomes.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Chemotherapy with platine

    Drug

    medical records that patients received neoadjuvant systemic chemotherapy platine based

Treatment groups

87 Participants
are divided into 1 treatment group
Group A: MIBC patients who received NAT1 intervention

Trial outcomes

Primary outcomes

1

Evaluating the factors affecting the response of neoadjuvant chemotherapy in muscle invasive bladder cancer

evaluating the neoadjuvant respose by clinical examination and radiological tools ( CT , MRI ) according to Recist criteria

Time frame
3 to 6 months (from previous medical reports )

Secondary outcomes

1

Disease free survival (DFS)

DFS the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.

Time frame
thorough study completion (an average 1 year )
2

overall survival (OS)

OS: defined as the length of time from either the date of diagnosis or the start of treatment for cancer, that patients are still alive.

Time frame
from the randomization until the date of 1st decument progression or death from any cause , whichever come first assesed up to 100 weeks
3

Progression Free Survival ( PFS )

the average lenght of time after the start of treatment in which a person is alive and their cancer does not grow or spread

Time frame
an average 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sara Mahmoud Ahmed Mahmoud

Lead sponsor

Assiut University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: