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Adjuvant Chemotherapy Following Radical Cystectomy to Treat Locally Advanced Bladder Cancer

NCT ID: NCT02074189

Last Updated: 2014-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2019-04-30

Brief Summary

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Effect of adjuvant chemotherapy to control tumor progression in patients after cystectomy for locally advanced bladder cancer.

Detailed Description

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Effect of adjuvant chemotherapy based on Gemcitabine and Cisplatin to control tumor progression in patients after cystectomy for locally advanced bladder cancer.

Conditions

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Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adjuvant Chemotherapy

Adjuvant Chemotherapy(Gemcitabine, Cisplatin):Gemcitabine 1000 mg/m2 iv,D1,D8,D15;cisplatin 70 mg/m2 iv,D2.With 4 cycles. Treatment begins between 1-5 weeks after radical operation (within 42 days is recommended)

Group Type ACTIVE_COMPARATOR

Gemcitabine, Cisplatin

Intervention Type DRUG

Gemcitabine 1000 mg/m2 iv,D1,D8,D15;cisplatin 70 mg/m2 iv,D2.With 4 cycles. Treatment begins between 1-5 weeks after radical operation (within 42 days is recommended)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Gemcitabine, Cisplatin

Gemcitabine 1000 mg/m2 iv,D1,D8,D15;cisplatin 70 mg/m2 iv,D2.With 4 cycles. Treatment begins between 1-5 weeks after radical operation (within 42 days is recommended)

Intervention Type DRUG

Other Intervention Names

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GCT

Eligibility Criteria

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Inclusion Criteria

1. Male or female, 18 years of age or older, estimated life expectancy ≥ 6 months.
2. Pathologically confirmed localized invasive bladder cancer following standardize radical cystectomy and pelvic lymphadenectomy.
3. Transitional cell carcinoma of bladder, stage pT3N0M0.Transitional cell carcinoma may be with or without squamous cell carcinoma and/or adenocarcinoma components.
4. Electrocorticography(ECOG) performance status 0-2.
5. Blood routine:Absolute neutrophil count (ANC) ≥ 1500/μL,White blood cell count ≥ 3000/μLPlatelets ≥ 100,000/μL,Hemoglobin ≥ 10.0 g/dL,
6. Total serum bilirubin≤ 1.5 x upper limit of normal (ULN).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).
7. Creatinine clearance rate,Ccr ≥ 60%
8. ECG：no arrhythmias, no myocardial infarction.

* 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

1. Past history of systemic chemotherapy
2. Serious heart and lung dysfunction.
3. Associated with central or peripheral neuropathy greater than 2 grade.
4. Evidence of distant metastasis beyond the pelvis.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Zhiwen Chen

M.D,Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhiwen Chen, M.D,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Southwest Hospital, China

Locations

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Southwest hospital,China

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2012XLC02

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2012XLC02-1

Identifier Type: -

Identifier Source: org_study_id