NCT02074189

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

February 28, 2014

Status Verified

February 1, 2014

Enrollment Period

5.1 years

First QC Date

February 26, 2014

Last Update Submit

February 27, 2014

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • cancer progressive free survival rate

    60 months

Secondary Outcomes (1)

  • overall survival

    60 months

Study Arms (2)

Adjuvant Chemotherapy

ACTIVE COMPARATOR

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)

Drug: Gemcitabine, Cisplatin

Control

NO INTERVENTION

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

Gemcitabine, CisplatinDRUG

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)

Also known as: GCT
Adjuvant Chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest hospital,China

Chongqing, Chongqing Municipality, 400030, China

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

GemcitabineCisplatin

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Zhiwen Chen, M.D,Ph.D

    Southwest Hospital, China

    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
M.D,Ph.D

Study Record Dates

First Submitted

February 26, 2014

First Posted

February 28, 2014

Study Start

March 1, 2014

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

February 28, 2014

Record last verified: 2014-02

Locations

CN(1)