Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C in Treating High-risk NMIBC Patients
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShaogang Wang
About this trial
The goal of this clinical trial is to learn if neoadjuvant intravesical instillation of mitomycin C combined with en-bloc surgery works to treat high-risk non-muscle-invasive bladder cancer (NMIBC) patients. It will also learn about the safety of neoadjuvant intravesical instillation of mitomycin C. The main questions it aims to answer are:
Does neoadjuvant intravesical instillation of mitomycin C heighten the 1-year recurrence-free survival (RFS) rate for high-risk non-muscle-invasive bladder cancer (NMIBC) patients? What medical problems do participants have when taking neoadjuvant intravesical instillation of mitomycin C? Researchers will compare neoadjuvant intravesical instillation of mitomycin C to a placebo (normal saline) to see if neoadjuvant intravesical instillation of mitomycin C works to treat high-risk NMIBC.
Participants will:
Take neoadjuvant intravesical instillation of mitomycin C or a placebo twice，1 day and 4 hours before en-bloc surgery Visit the clinic once every 8 weeks for checkups and tests Keep track of the recurrence and progression of the tumor.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily sign an informed consent form, understand the study and are willing and able to follow and complete all trial procedures
Gender is not limited, age between 18 to 75 years old (inclusive of boundary values)
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Previously confirmed non-muscle-invasive bladder cancer by imaging and pathology
Disqualifiers
The primary tumor is upper urinary tract urothelial carcinoma of the renal pelvis and ureter
Patients who have suffered from malignant tumors other than bladder urothelial carcinoma within 5 years before enrollment. However, the following patients are included (eligible for enrollment): ① Patients with locally low-risk prostate cancer (staging ≤T2b, Gleason score ≤7, and PSA ≤ 20ng/ml, with no recurrence after treatment as determined by follow-up PSA levels); ② Patients with low-risk prostate cancer (staging T1/T2a, Gleason score ≤7, and PSA ≤10ng/ml, in the observation phase without treatment; ③ Patients who meet other enrollment criteria but have very low risk of metastasis or death from malignant tumors, and who show no recurrence or metastasis after standard treatment, as confirmed by imaging and disease-specific tumor marker tests, such as fully treated carcinoma in situ of the cervix, basal or squamous cell skin cancer; in situ ductal carcinoma after treatment surgery, etc
Patients with active autoimmune diseases who have required systemic treatment (i.e., long-term use of corticosteroids or immunosuppressive drugs) within the past two years. Replacement therapy (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is excluded
Patients who are expected to have major surgery during the study period or who have undergone major surgery within 4 weeks before dosing and have not fully recovered
Trial design
Design model
Parallel
Treatments tested in this trial
Mitomycin C (MMC)
DrugWhen administering neoadjuvant intravesical instillations, instruct the patient to lie flat on the treatment bed and cover with a waterproof pad. Disinfect the perineal area 2-3 times. Under sterile conditions, insert a catheter and drain the bladder of urine completely. Slowly instill the prepared instillation solution (mitomycin) into the bladder. If the patient experiences pain during the instillation, stop the infusion immediately, and continue when the pain subsides. If the patient still cannot tolerate it, discontinue the instillation treatment for this session. After the medication is instilled into the bladder, the catheter can be removed immediately or left in place. Instruct the patient to hold their urine for as long as possible under suitable conditions for 2 hours, and to change positions intermittently while the medication is retained in the bladder. The neoadjuvant intravesical instillation cycle is twice (one day and 4 h before en-bloc surgery）
Normal Saline (Placebo)
DrugWhen administering neoadjuvant intravesical instillations, instruct the patient to lie flat on the treatment bed and cover with a waterproof pad. Disinfect the perineal area 2-3 times. Under sterile conditions, insert a catheter and drain the bladder of urine completely. Slowly instill the prepared instillation solution (Normal Saline) into the bladder. If the patient experiences pain during the instillation, stop the infusion immediately, and continue when the pain subsides. If the patient still cannot tolerate it, discontinue the instillation treatment for this session. After the medication is instilled into the bladder, the catheter can be removed immediately or left in place. Instruct the patient to hold their urine for as long as possible under suitable conditions for 2 hours, and to change positions intermittently while the medication is retained in the bladder. The neoadjuvant intravesical instillation cycle is twice (one day and 4 h before en-bloc surgery）
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Neoadjuvant intravesical instillation mitomycin C combined with en-bloc surgeryExperimental treatment 1 intervention
Group B: Neoadjuvant intravesical instillation normal saline combined with en-bloc surgeryPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
1-year recurrence-free survival rate
The one-year recurrence-free survival rate, as assessed by researchers, is defined as the proportion of patients who are free of tumor recurrence at one year after randomization. Recurrence is defined as any pathological level of urothelial carcinoma confirmed by cystoscopy and biopsy during the one-year follow-up period starting from the time of randomization.
Time frame
One year after randomizationSecondary outcomes
1
Progression free survival
This was determined by cystoscopy and pathology every eight weeks for one year and telephone follow-up every one year after one year until tumor progression and patient death from any cause, or five years after the end of the study. Defined as the time between the start of randomization and progression of disease or death from any cause, whichever occurs first. Disease progression was defined as an increase in bladder tumors from Ta/T1 to T1/ T2 or larger, lymph node metastasis and distant metastasis, or an increase in tumor grade from low to high.
Time frame
Every eight weeks for one year and telephone follow-up every one year after one year until tumor progression and patient death from any cause, or five years after the end of the study.2
overall survival
Telephone follow-up was conducted every 1 year after the start of randomization until death from any cause or 5 years after the end of the study.
Time frame
up to 5 years after the end of the study.3
Health-related quality of life
The health-related quality of life of the patients was assessed by EORTC QLQ-C30
Time frame
up to One year after discharge4
Adverse event
Adverse events were coded using the International Dictionary of Medical Terms (MedDRA), and adverse events (TEAE) during treatment were aggregated by Systematic Organ Classification (SOC), Preferred term (PT), and NCI-CTCAE grading. The number, frequency and incidence of adverse events and drug-related adverse events of all subjects were counted. Make a list of adverse events. This is determined by interview, physical examination, as well as the patient's vital signs and laboratory tests.
Time frame
up to Eight weeks after dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shaogang Wang
Lead sponsor
Tongji Hospital
Sponsor institution
Source ClinicalTrials.gov