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

NCT02861196 | Completed

• 1 other identifier: LC 2015L12
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• bladder preservation rate

  bladder preservation rate

  3 years

Study Arms (1)

Therapy Arm

EXPERIMENTAL

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

Interventions

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.

Therapy Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Radiotherapy, Intensity-Modulated; Cystectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jianzhong Shou, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 10, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

CN (1)