Organ-preserved tetra-modality therapy for patient having muscle invasive urothelial carcinoma 'OMC-regimen'

Organ-preserved tetra-modality therapy for patient having muscle invasive urothelial carcinoma 'OMC-regimen' - OMCRT

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012968

Enrollment

500

Registered

2014-01-26

Start date

2012-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle invasive bladder carcinoma (MIBC) including regional lymph node metastasis

Interventions

Tetra-modality therapy for MIBC

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Muscle invasive urothelial cancer (front line or following the progression of a superficial tumor), pTis-pT4 stage without non regional lymphatic impairment (N3) and without detectable metastases (M0). The proof of invasive tumor to the muscle should be brought by a transurethral resection under anaesthesia less than 8 weeks before or, in the absence, by superficial biopsies and formal imaging. Multiples biopsies in the bladder must also be performed. Age &#8805; 18 years Life expectancy &#8805; 6 months Kanorfsky index &#8805; 70 % (WHO 0, 1, 2) Biological criteria: neutrophils &#8805; 1500/mm3, Platelets &#8805; 100 000/mm3, haemoglobin &#8805; 10 g/dl, creatinine clearance > 60 ml/mn Efficient contraception for premenopausal women, maintained during the whole treatment and up to two months after the completion of radiotherapy. No radiotherapy or chemotherapy history except for in situ bladder lesions. No contraindication to gemcitabine or cisplatin. No contraindication to radiotherapy Information letter and informed consent signed

Exclusion criteria

Exclusion criteria: Epidermoid carcinoma or adenocarcinoma Distance metastases or extrapelvic node positivity Severe digestive history (ulcerative colitis, complicated diverticulitis) Pregnancy and breast feeding

Design outcomes

Primary

Measure	Time frame
1. Disease-free surviva: The time to relapse is defined as the time from the date of randomization to the date of the first event. Time to relapse for patients without any event (local, regional, distance, or death) will be censored at the date of latest information. 2. CR inductivity rate assessed histologically applying TURBT three months after the treatment sequence as well as computed tomography to evaluate metastasis.	—

Measure

Time frame

1. Disease-free surviva: The time to relapse is defined as the time from the date of randomization to the date of the first event. Time to relapse for patients without any event (local, regional, distance, or death) will be censored at the date of latest information. 2. CR inductivity rate assessed histologically applying TURBT three months after the treatment sequence as well as computed tomography to evaluate metastasis.

—

Secondary

Measure	Time frame
1. Overall survival:the time to death is defined as time from the randomization to the date of death from any cause, or to the date on which latest information is obtained. 2. &#8226;Acute and late toxicities: acute and late toxicities will be scored according to the NCI-CTC v4.0. 3. &#8226;Quality of life using questionnaires (i.e. IPSS, OABSS, IIEF5,etc)	—

Countries

Japan

Contacts

Public ContactKazumasa Komura

Osaka medical college Department of urology

uro051@poh.osaka-med.ac.jp81-726-83-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

Organ-preserved tetra-modality therapy for patient having muscle invasive urothelial carcinoma &#39;OMC-regimen&#39;