Adjuvant Intraarterial Chemotherapy Following Surgery to Treat Locally Advanced Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01627197
Recruitment Status : Recruiting
First Posted : June 25, 2012
Last Update Posted : October 16, 2017
Information provided by (Responsible Party):
ZHOU FANGJIAN, Sun Yat-sen University

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

Condition or disease Intervention/treatment Phase
Bladder Cancer Procedure: Surgery of percutaneous catheter system Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Intraarterial Chemotherapy Following Surgery in Treating Patients With Locally Advanced Bladder Cancer
Study Start Date : June 2012
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. cancer progressive free survival rate [ Time Frame: 60 months ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 60 months ]
  2. Cancer specific survival [ Time Frame: 60 months ]
  3. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01627197

Contact: Fang-Jian Zhou, M.D Ph.D +86(20)13922735659
Contact: Zhuo-Wei Liu, M.D Ph.D +86(20)13610138571

China, Guangdong
Cancer Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Fang-Jian Zhou, M.D Ph.D   
Contact: Zhuo-wei Liu   
Principal Investigator: Fang-Jian Zhou, M.D Ph.D         
Sub-Investigator: Zhuo-Wei Liu, M.D Ph.D         
Sponsors and Collaborators
Sun Yat-sen University
Principal Investigator: Fang-Jian Zhou, M.D Ph.D Sun Yat-sen University

Responsible Party: ZHOU FANGJIAN, Chair of Urology, Sun Yat-sen University Identifier: NCT01627197     History of Changes
Other Study ID Numbers: 2012009
2012009 ( Other Identifier: Sun Yat-sen University Clinical Research 5010 Program )
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by ZHOU FANGJIAN, Sun Yat-sen University:
Effects of Chemotherapy
intraarterial chemotherapy

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases