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

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ClinicalTrials.gov Identifier: NCT02861196
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Jianzhong Shou, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Procedure: Intensity modulated radiation therapy, Radical cystectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Research on the Combined-Modality Treatment Model of Bladder Preservation in Muscular Invasive Bladder Cancer
Actual Study Start Date : September 2015
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Therapy Arm
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.
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.




Primary Outcome Measures :
  1. 5-year cancer specific survival [ Time Frame: 5 years ]
    5-year cancer specific survival



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861196


Locations
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China, Beijing
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
Sponsors and Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Investigators
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Study Chair: Jianzhong Shou, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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Responsible Party: Jianzhong Shou, Clinical Professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02861196     History of Changes
Other Study ID Numbers: LC 2015L12
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases