Adjuvant Intraarterial Chemotherapy Following Surgery to Treat Locally Advanced Bladder Cancer - Full Text View

Purpose

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

Condition	Intervention	Phase
Bladder Cancer	Drug: Gemcitabine, Cisplatin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Adjuvant Intraarterial Chemotherapy Following Surgery in Treating Patients With Locally Advanced Bladder Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

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:	212
Study Start Date:	June 2012
Estimated Study Completion Date:	December 2021
Estimated Primary Completion Date:	April 2019 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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): 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).	Drug: Gemcitabine, Cisplatin 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) Other Name: GEMZAR
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

Arms

Assigned Interventions

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): 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).

Drug: Gemcitabine, Cisplatin

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)

Other Name: GEMZAR

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627197

Locations

China, Guangdong
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Principal Investigator:

Fang-Jian Zhou, M.D Ph.D

Sun Yat-sen University

More Information

No publications provided

Responsible Party:	ZHOU FANGJIAN, Chair of Urology, Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT01627197 History of Changes
Other Study ID Numbers:	2012009, 2012009
Study First Received:	June 13, 2012
Last Updated:	April 1, 2013
Health Authority:	China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:

Effects of Chemotherapy

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses

Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013