a Genome-based Platform to Predict Patients That Can Achieve Bladder Preservation in Muscle Invasive Bladder Cancer Patients

NCT04686149 | Unknown DMC

• 1 other identifier: 4-2020-1149
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aimed to develop a genome-based platform to predict patients who can achieve bladder preservation after neoadjuvant treatment. The main treatments for invasive bladder cancer are radical cystectomy and intrapelvic lymph node dissection, but 50% of patients experience recurrence within 2 years after surgery. The recurrence after surgery is associate with T3 stage, the presence of invading soft tissue around the bladder and N1, lymph node metastasis. Therefore, various methods are being tried to reduce recurrence and metastasis, among which preoperative chemotherapy has been reported to increase survival rate. Based on this, preoperative chemotherapy followed by radical cystectomy are also recommended. However, there are several limitations; The surgery may be delayed in case of non-responsive to chemotherapy, the difficulty of tolerance of chemotherapy as the patients are relatively old in bladder cancer. Therefore, the preoperative concurrent chemoradiotherapy can be considered as a treatment effectively lower the recurrence. In several retrospective study has reported that preoperative radiation induces the down-staging and leads to prolonged progression free survival. However, after radical cystectomy, there is discomfort for patients regarding the removal of the bladder. Treating the bladder while preserving the bladder is getting its attention. The representative treatment is performing neoadjuvant concurrent chemotherapy followed by transurethral resection of bladder tumor. The bladder preserving treatment is performed in patients who have unresectable, locally advanced bladder cancer or are not medically appropriate for surgery. The 5-year overall survival is reported to be around 50-60%. To date, no clinical trial has been conducted to compare whether concurrent chemoradiotherapy can achieve the comparable clinical outcome as radical cystectomy in operable conditions. Therefore, in order to perform the bladder preserving treatment, a platform selecting patients who can preserve the bladder from bladder preserving treatment in advance is needed. Responsiveness to radiotherapy is a combination of various factors, and radiation sensitivity of tumors is the most important. The recent study has been demonstrated that physician can predict radiation sensitivity using genomic data. In this study, we intend to develop a platform that can predict responsiveness to radiotherapy and select patients who can preserve bladder using genomic information.

Conditions

Muscle-Invasive Bladder Carcinoma

Keywords

Bladder cancer; Bladder preservation; Genome-based platform; preoperative chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Bladder preservation rate

  The rate of patients achieve bladder preservation without radical cystectomy

  up to 2 years

Secondary Outcomes (1)

• Pathologic complete response rate

  up to 2 years

Study Arms (1)

Neo CCRT+Neo CTx +/- cystectomy

Patients receive neoadjuvant CCRT and neoadjuvant CTx. Radical cystectomy is performed depending on pathologic response. The patients showing clinical complete response after neoadjuvant CCRT and initially stage T2N0M0 are not treated with neoadjuvant chemotherapy.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with muscle invasive bladder cancer are subject to this trial. For bladder preservation, the patients receive neoadjvuvant CCRT. In case that clinical CR status obtained after CCRT in patients initally T2N0M0, no additional treatment is performed. Patients without clinical CR status are treated with neoadjuvant chemotherapy. After chemotherapy, the response is evaluated. If residual tumor is found, the radical cystectomy is performed.

You may qualify if:

• Patients older than 19 years old
• Clinically or histologically diagnosed urothelial carcinoma bladder cancer
• Patients who satisfy all of the following conditions with bladder cancer stage T2-4a, N0-1 according to 8th edition of American Joint Committee on Cancer
• Muscle invasive bladder cancer confirmed by cystoscopy
• Stage T2-4a, N0-1 in CT or MRI
• Performance status 0 or 1 based on ECOG
• Patients agreed to provide the tissue sample obtained from TURB
• Diseases can be evaluated according to RECIST Version 1.1
• Patients who voluntarily agreed to informed consent

You may not qualify if:

• Patients with distant metastasis
• Patients with uncontrolled viral infection (HIV, HBV, HCV)
• Patient who are pregnant, or have possibility of pregnancy and are on lactating
• Hypersensitivity or history of allergic to the drug being used
• Patients with cerebrovascular disease, complications, and infections that are not medically controlled
• Patients with history of other malignant diseases within the past 5 years (excluding cured non-melanoma skin cancer or in situ cervical cancer)
• Those who are taking drugs that can cause drug interactions with chemotherapy
• Patients who withdraw consent

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Severance Hospital

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

RNA sequencing was performed after RNA was isolated from the tissue sample obtained from TURB

MeSH Terms

Conditions

Urinary Bladder Neoplasms

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

Study Officials

• Woong Sub Koom

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Woong Sub Koom

CONTACT

+82-10-8818-1356; MDGOLD@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: December 28, 2020
• Study Start: January 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 28, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)