Adjuvant Intraarterial Chemotherapy Following Surgery to Treat Locally Advanced Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Adjuvant Intraarterial Chemotherapy Following Surgery in Treating Patients With Locally Advanced Bladder Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01627197
• Other study ID #: 2012009
• Secondary ID: 2012009
• Status: Recruiting
• Phase: Phase 3
• First received: June 13, 2012
• Last updated: October 13, 2017
• Start date: June 2012
• Est. completion date: December 2021

Study information

• Verified date: October 2017
• Source: Sun Yat-sen University
• Contact: Fang-Jian Zhou, M.D Ph.D
• Phone: +86(20)13922735659
• Email: zhoufj[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Effect of adjuvant intra-arterial chemotherapy to control tumor progression in patients cystectomized for locally advanced bladder cancer.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 212
• Est. completion date: December 2021
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Cancer Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cancer progressive free survival rate		60 months
Secondary	overall survival		60 months
Secondary	Cancer specific survival		60 months
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		12 months