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Adjuvant Chemotherapy Following Radical Cystectomy to Treat Locally Advanced Bladder Cancer

Primary Purpose

Bladder Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Gemcitabine, Cisplatin
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Southwest hospital,China

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Adjuvant Chemotherapy

Control

Arm Description

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)

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

Outcomes

Primary Outcome Measures

cancer progressive free survival rate

Secondary Outcome Measures

overall survival

Full Information

First Posted
February 26, 2014
Last Updated
February 27, 2014
Sponsor
Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT02074189
Brief Title
Adjuvant Chemotherapy Following Radical Cystectomy to Treat Locally Advanced Bladder Cancer
Official Title
Adjuvant Chemotherapy Following Radical Cystectomy to Treat Locally Advanced Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adjuvant Chemotherapy
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Gemcitabine, Cisplatin
Other Intervention Name(s)
GCT
Intervention Description
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)
Primary Outcome Measure Information:
Title
cancer progressive free survival rate
Time Frame
60 months
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, 18 years of age or older, estimated life expectancy ≥ 6 months. Pathologically confirmed localized invasive bladder cancer following standardize radical cystectomy and pelvic lymphadenectomy. Transitional cell carcinoma of bladder, stage pT3N0M0.Transitional cell carcinoma may be with or without squamous cell carcinoma and/or adenocarcinoma components. Electrocorticography(ECOG) performance status 0-2. Blood routine:Absolute neutrophil count (ANC) ≥ 1500/μL,White blood cell count ≥ 3000/μLPlatelets ≥ 100,000/μL,Hemoglobin ≥ 10.0 g/dL, 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). Creatinine clearance rate,Ccr ≥ 60% 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: Past history of systemic chemotherapy Serious heart and lung dysfunction. Associated with central or peripheral neuropathy greater than 2 grade. Evidence of distant metastasis beyond the pelvis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiwen Chen, M.D,Ph.D
Organizational Affiliation
Southwest Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest hospital,China
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China

12. IPD Sharing Statement

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Adjuvant Chemotherapy Following Radical Cystectomy to Treat Locally Advanced Bladder Cancer

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