Adjuvant Intraarterial Chemotherapy Following Surgery to Treat Locally Advanced Bladder Cancer

NCT01627197 | Completed Phase 3 DMC

• 1 other identifier: 2012009
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bladder Cancer

Keywords

Effects of Chemotherapy; intraarterial chemotherapy

Outcome Measures

Primary Outcomes (1)

• recurrence free survival rate

  60 months

Secondary Outcomes (3)

• overall survival

  60 months

• Cancer specific survival

  60 months

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  12 months

Study Arms (2)

Intraaterial chemotherapy

ACTIVE COMPARATOR

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

Watchful waiting

NO INTERVENTION

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

Interventions

Surgery of percutaneous catheter system PROCEDURE

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.

Intraaterial chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Fang-Jian Zhou, M.D Ph.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Urology

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: June 25, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: November 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)