Adjuvant Intraarterial Chemotherapy Following Surgery to Treat Locally Advanced Bladder Cancer
This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
ZHOU FANGJIAN, Sun Yat-sen University
First received: June 13, 2012
Last updated: May 10, 2016
Last verified: May 2016
Effect of adjuvant intra-arterial chemotherapy to control tumor progression in patients cystectomized for locally advanced bladder cancer.
Procedure: Surgery of percutaneous catheter system
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Adjuvant Intraarterial Chemotherapy Following Surgery in Treating Patients With Locally Advanced Bladder Cancer
Primary Outcome Measures:
- cancer progressive free survival rate [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- overall survival [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
- Cancer specific survival [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2019 (Final data collection date for primary outcome measure)
Active Comparator: Intraaterial chemotherapy
This is an open-label, prospective, multicenter, randomized, controlled phase 3 two-arm study.Patients with locally advanced TCC of the bladder are randomized to 1 of 2 treatment arms
Arm 1 (treatment):'Surgery of percutaneous catheter system for arterial chemotherapy is done in the Department of Invasive Technology. All medications were administered using percutaneous catheter system via a modified Seldinger technique.Gemcitabine 800 mg/m2 intra-arterial,cisplatin 25 mg/m2 intra-arterial once a week for 3 weeks followed by 1-week rest period. Maximum of 3 cycles. Treatment begins between 1-5 weeks after radical operation (within 40 days is recommended).
Procedure: Surgery of percutaneous catheter system
Intraarterial (IA) catheterization was done in the Department of Invasive Technology. All medications were administered using percutaneous catheter system via a modified Seldinger technique. An angiographic catheter was inserted through the femoral artery into the internal iliac artery. The catheter tips were located superior to the origin of bilateral common artery.
No Intervention: Watchful waiting
Arm 2 (control): No immediate post-surgery treatment. Patients undergo observation followed by cisplatin and gemcitabine as in arm I at local relapse, or receive intravenously chemotherapy with cisplatin and gemcitabine at multiple metastases
For locally advanced bladder cancer patients, tumor relapse rates after radial cystectomy were even as high as 50%-62%.Five-year disease-specific survival and OS rates in the organ-confined disease (defined as ≤pT3a) were 78.9% and 68%, respectively. For the non-organ-confined disease (defined as pT3b or higher), the rates were about 36.8% and 30.3%, respectively.Systemic chemotherapy can only prolong survival for up to 14.8 months, although with multiple severe adverse effects, such as neutrocytopenia, infection/sepsis, renal dysfunction, mucositis, or gastrointestinal toxicity. Additionally, the mortality rate associated with systemic chemotherapy was about 1%-4%.Therefore, the objective of our study was to determine if adjuvant intra-arterial chemotherapy with GC was able to reduce the systemic drug toxicities and yield a better clinical outcome.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Pathologically confirmed localized invasive bladder cancer following standardize radical cystectomy.
- Transitional cell carcinoma of bladder, stage pT3-4,N1-3,M0.Transitional cell carcinoma may be with or without squamous cell carcinoma and/or adenocarcinoma components.
- Male or female, 18 years of age or older, estimated life expectancy ≥ 6 months.
- ECOG performance status 0 or 1.
- Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase[SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x upper limit of normal (ULN).Total serum bilirubin≤ 1.5 x upper limit of normal (ULN).
- Absolute neutrophil count (ANC) ≥ 1500/μL
- Platelets ≥ 75,000/μL
- Hemoglobin ≥ 8.0 g/dL
- White blood cell count ≥ 3500/μL
- Creatinine clearance rate,Ccr ≥ 40ml/min
- Cardiac function level 0~2.
- Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests,and other study procedures.
- Bladder cancer without any transitional cell carcinoma component,such as adenocarcinoma,squamous cell carcinoma,small cell carcinoma
- Evidence of distant metastasis beyond the pelvis.
- No definitely pathological stage,such as no pathologic examination of perivesical fat,unable to differentiate pT2 and pT3,not performing lymph node dissection or regional lymph nodes cannot be assessed as the dissected lymph node number is less than ten.
- Prior neoadjuvant chemotherapy (systemic or intra-arterial) three months preoperatively, not including intra-vesical infusion chemotherapy.
- Prior pelvic radiation therapy dosage ≥ 30Gy six months preoperatively.
- Serious liver and kidney dysfunction.
- Accompanied with other serious diseases.
- Severe/unstable angina, arrhythmia,symptomatic heart failure, hypertension that cannot be controlled by medications and 6 months for myocardial infarction.
- Non-compliance of regular follow-up due to psychological, social, family and geographical and other reasons.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01627197
|Cancer Center, Sun Yat-sen University
|Guangzhou, Guangdong, China, 510060 |
Sun Yat-sen University
||Fang-Jian Zhou, M.D Ph.D
||Sun Yat-sen University
||ZHOU FANGJIAN, Chair of Urology, Sun Yat-sen University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 13, 2012
||May 10, 2016
||China: Food and Drug Administration
Keywords provided by Sun Yat-sen University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 26, 2016
Urinary Bladder Neoplasms
Neoplasms by Site
Urinary Bladder Diseases