NMIBC
Conditions
Brief summary
Residual tumors after transurethral resection of bladder tumors (TURBT) range from 17-70%, and floating tumor cells from traditional segmental resection may lead to recurrence if they re-implant in the bladder wall. Immediate systemic chemotherapy post-surgery aims to eliminate microlesions promptly and minimize recurrence risk, yet its safety and efficacy require further exploration. This prospective, single-arm study delves into evaluating the efficacy and safety of immediate postoperative systemic chemotherapy in patients with suspected high-risk non-muscle-invasive bladder cancer.
Detailed description
Bladder cancer ranks as the ninth most prevalent cancer globally, with urothelial carcinoma being the primary form, leading to over 220,000 deaths annually. While 70-75% of bladder cancer cases initially present as non-muscle invasive bladder cancer (NMIBC) with favorable prognoses, the recurrence rate can reach 78% within five years post-standard treatment. The primary objective of transurethral resection of bladder tumors (TURBT) is to accurately diagnose and completely eliminate all visible lesions, as the quality of resection significantly impacts prognosis. However, a systematic review reveals a notable risk of residual tumor post-initial resection. For individuals with high-risk non-muscle invasive bladder cancer (NMIBC), EAU guidelines recommend a follow-up resection 2-6 weeks later. Clinical trials have demonstrated that administering a single chemotherapy session within 24 hours of the initial resection can lower recurrence rates. This approach may work by eradicating floating tumor cells, ablating residual tumor cells, and addressing overlooked small tumors. Gemcitabine and cisplatin (GC) have good efficacy and tolerance in patients with bladder cancer and have become the most commonly used regimen in the neoadjuvant treatment of bladder cancer. There is currently a lack of strong evidence that GC chemotherapy 24 hours after surgery can safely and effectively reduce the risk of recurrence in suspected high-risk NMIBC cases. Our goal is to conduct a prospective clinical trial to investigate the feasibility of this treatment method by evaluating the incidence of adverse events and recurrence-free survival in this group of patients by administering systemic chemotherapy 24 hours after TURBT for patients with suspected high-recurrence bladder cancer.
Interventions
PROCEDUREImmediate postoperative chemotherapy
Systemic chemotherapy with cisplatin/gemcitabine intravenous infusion within 24 hours after TURBT
Sponsors
Changhai Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a history and cystoscopy results indicating high-risk NMIBC: * High-grade T1 * Any recurrent high-grade Ta * High-grade Ta & Tumor diameter greater than 3 cm or multifocal * Any CIS * Any BCG failure in patients with high-grade disease * Any variant histology * Any LVI * Any high-grade prostatic urethral involvement * Patients in generally good condition with a follow-up period of 2 years
Exclusion criteria
* Bladder cancer other than UC * MIBC or benign diseases * Incomplete tumor resection * Active infection * Concurrent upper urinary tract or prostatic urethral UC * Previous systemic chemotherapy, immunotherapy, or radiotherapy * Leukopenia/thrombocytopenia * Serum creatinine greater than twice the normal level * Uncontrollable urinary tract infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| One-year recurrence-free survival rate | About two years after the first immediate chemotherapy | The percentage of patients who remain cancer-free for one year after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological downstaging rate | About 2-6 weeks after the first immediate chemotherapy | The percentage of patients whose cancer has decreased in stage following treatment. |
| The incidence of grade ≥ 3 adverse events（AEs） | About two years after the first immediate chemotherapy | The frequency of severe or serious side effects experienced by patients during a clinical trial or medical treatment(CTCAE V5.0 ). |
| UroCAD.MRD Index | TURBT perioperative period, about 15 days | Body fluid samples were collected from patients before and after TUBRT and chemotherapy for chromosomal instability testing, and the residual tumor status of patients was analyzed by analyzing the changes in the UroCAD.MRD index. |
Countries
China
Contacts
Primary ContactShuxiong Zeng, M.D. Ph.D
Outcome results
None listed