Clincosm LogoSign in Get a demo

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

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT02861196
Collaborator
(none)
59
Enrollment
1
Location
1
Arm
36
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intensity modulated radiation therapy, Radical cystectomy
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
59 participants
Allocation:
N/A
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 :
Sep 1, 2015
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Sep 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. bladder preservation rate [3 years]

    bladder preservation rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

  • Study Chair: Jianzhong Shou, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jianzhong Shou, Clinical Professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT02861196
Other Study ID Numbers:
  • LC 2015L12
First Posted:
Aug 10, 2016
Last Update Posted:
Dec 17, 2020
Last Verified:
Dec 1, 2020
Additional relevant MeSH terms:
Urinary Bladder Neoplasms

Study Results

No Results Posted as of Dec 17, 2020