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Completed

NCT Number: NCT02861196

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

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensity modulated radiation therapy, Radical cystectomy

Procedure

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

Primary outcomes

  1. bladder preservation rate

    Time frame: 3 years

    bladder preservation rate

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 10, 2016
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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