Clinical trial NCT01627197: Adjuvant Intraarterial Chemotherapy Following Surgery to Treat Locally Advanced Bladder Cancer
Official title: Adjuvant Intraarterial Chemotherapy Following Surgery in Treating Patients with Locally Advanced Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bladder Cancer
Keywords: Effects of Chemotherapy
intraarterial chemotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2012-06-25
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: recurrence free survival rate
timeFrame: 60 months
Secondary outcomes:
measure: overall survival
timeFrame: 60 months
measure: Cancer specific survival
timeFrame: 60 months
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Fang-Jian Zhou, M.D Ph.D
role: PRINCIPAL_INVESTIGATOR
References: