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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: Bladder Cancer

Treatments: Procedure: Intensity modulated radiation therapy, Radical cystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02861196

LC 2015L12

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

Therapy Arm

Experimental group

Description:

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.

Treatment:

Procedure: Intensity modulated radiation therapy, Radical cystectomy