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NCT02861196 Clinical Trial

Research on the Combined-Modality Treatment Model of Bladder Preservation in Muscular Invasive Bladder Cancer

Bladder Cancer Clinical Trial

Official title:
Research on the Combined-Modality Treatment Model of Bladder Preservation in Muscular Invasive Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02861196
Other study ID # LC 2015L12
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date September 2018

Study information
Verified date December 2020
Source Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research aims to explore the therapeutic effect of neoadjuvant chemotherapy in muscular invasive bladder cancer of T2-4aN0M0, and the survival effect of combined-modality treatment model，then to clarify the probability of bladder preservation, corresponding cancer specific survival, and the quality of life.

Recruitment information / eligibility
Status Completed
Enrollment 59
Est. completion date September 2018
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. bladder urothelium carcinoma 2. cT2-4aN0M0 3. life expectancy=1 year 4. ECOG PS 0-1 5. have no previously received radiotherapy or chemotherapy 6. have no major organ dysfunction 7. have been provided informed written consent Exclusion Criteria: 1. extensive carcinoma in situ or ureter invaded 2. distant metastasis at primary diagnosis or lymphatic metastasis according to clinical diagnosis 3. have severe major organ dysfunction 4. cannot finish treatments because of other severe diseases or life expectance=6 months 5. exist other malignant tumors 6. have severe coagulation disorders 7. no other trails participated in 4 weeks

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Intensity modulated radiation therapy, Radical cystectomy
Postoperative Intensity modulated radiation therapy(IMRT) will be applied to effective team.Radical cystectomy will be applied to ineffective team.

Locations
Country Name City State
China Cancer Institute and Hospital, Chinese Academy of Medical Sciences Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary bladder preservation rate bladder preservation rate 3 years
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