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

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Procedure: Intensity modulated radiation therapy, Radical cystectomy

• Registration Number: NCT02861196
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-08-05
• Study First Posted: 2016-08-10
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-15
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Therapy Arm	Intensity modulated radiation therapy, Radical cystectomy	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.

Primary Outcome Measures

Name	Time	Method
bladder preservation rate	3 years	bladder preservation rate

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China