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

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intensity modulated radiation therapy, Radical cystectomy
Sponsored by
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Therapy Arm

Arm Description

Patients who have response to neoadjuvant chemotherapy will be separated into two groups (GI cT0-1 and G2 ≥cT2). G1receive concurrent radiochemotherapy, and G2 receive partial resection of the bladder+lymphadenectomy+adjuvant radiotherapy.Patients who have no response to neoadjuvant chemotherapy or disagree to receive the sequential treatment will receive the radical resection of bladder.

Outcomes

Primary Outcome Measures

bladder preservation rate
bladder preservation rate

Secondary Outcome Measures

Full Information

First Posted
August 3, 2016
Last Updated
December 15, 2020
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02861196
Brief Title
Research on the Combined-Modality Treatment Model of Bladder Preservation in Muscular Invasive Bladder Cancer
Official Title
Research on the Combined-Modality Treatment Model of Bladder Preservation in Muscular Invasive Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

4. Oversight

5. Study Description

Brief 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.

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
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapy Arm
Arm Type
Experimental
Arm Description
Patients who have response to neoadjuvant chemotherapy will be separated into two groups (GI cT0-1 and G2 ≥cT2). G1receive concurrent radiochemotherapy, and G2 receive partial resection of the bladder+lymphadenectomy+adjuvant radiotherapy.Patients who have no response to neoadjuvant chemotherapy or disagree to receive the sequential treatment will receive the radical resection of bladder.
Intervention Type
Procedure
Intervention Name(s)
Intensity modulated radiation therapy, Radical cystectomy
Intervention Description
Postoperative Intensity modulated radiation therapy(IMRT) will be applied to effective team.Radical cystectomy will be applied to ineffective team.
Primary Outcome Measure Information:
Title
bladder preservation rate
Description
bladder preservation rate
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: bladder urothelium carcinoma cT2-4aN0M0 life expectancy≥1 year ECOG PS 0-1 have no previously received radiotherapy or chemotherapy have no major organ dysfunction have been provided informed written consent Exclusion Criteria: extensive carcinoma in situ or ureter invaded distant metastasis at primary diagnosis or lymphatic metastasis according to clinical diagnosis have severe major organ dysfunction cannot finish treatments because of other severe diseases or life expectance≤6 months exist other malignant tumors have severe coagulation disorders no other trails participated in 4 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianzhong Shou, MD
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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