Hypofractionated IMRT With Concurrent Chemotherapy in Muscle-invasive Bladder Cancer (HIRACUM)

NCT05453682 | Recruiting

• 1 other identifier: SMC-2021-01-026
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the side effects, quality of life, and treatment effects of concurrent chemo-hypofractionated intensity-modulated radiation therapy in bladder cancer. Twenty fractionation within 4 weeks are performed using hypofractionated intensity-modulated radiation therapy. As for the radiation dose, 2.8-3.2 Gy at a time, total dose 56-64 Gy, to the high-risk target volume, and 2-2.2 Gy at a time, and 40-44 Gy, respectively, to the low-risk target volume. It aims to include more than 97% of the total dose to cover the entire PTV, and the minimum dose in the PTV is not lower than 95% of the prescribed dose, and the maximum dose does not exceed 107% of the prescribed dose. Chemotherapy before and after radiotherapy can be performed depending on the institutional policy. Among radiotherapy, chemotherapy is performed with platinum-based agents (cisplatin, carboplatin, etc.), and is administered once a week for a total of 3 or more.

Conditions

Bladder Cancer

Keywords

bladder cancer; hypofractionated radiotherapy

Outcome Measures

Primary Outcomes (1)

• bladder preservation disease-free survival rate

  Two-year bladder preservation disease-free survival rate when concurrent chemo-hypofractionated intensity-modulated radiation therapy

  2 years after participation of all subjects

Secondary Outcomes (5)

• Number of participants with treatment-related adverse events as assessed by Number of participants with treatment-related adverse events as assessed CTCAE v5.0 radiation therapy

  3 months after participation

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0radiation therapy

  5 years after participation

• EORTC QOL-C30 measurement

  5 years after participation

• 2 year disease-free survival when concurrent chemo-hypofractionated intensity-modulated radiation therapy

  2 years after participation of all subjects

• overall survival when concurrent chemo-hypofractionated intensity-modulated radiation therapy

  5 years after participation of all subjects

Study Arms (1)

Hypo IMRT

EXPERIMENTAL

in muscle invasive bladder cancer, hypofractionated IMRT with chemotherapy

Radiation: hypo-IMRT

Interventions

hypo-IMRT RADIATION

Twenty fractionation within 4 weeks are performed using hypofractionated intensity-modulated radiation therapy. As for the radiation dose, 2.8-3.2 Gy at a time, total dose 56-64 Gy, to the high-risk target volume, and 2-2.2 Gy at a time, and 40-44 Gy, respectively, to the low-risk target volume.

Hypo IMRT

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with bladder cancer histologically
• Patients with muscle layer involvement in transurethral resection (pT2 or higher)
• Patients without pelvic lymph node metastasis by computed tomography (CT) or magnetic resonance images (MRI) of the pelvis.
• Patients who want bladder conservation treatment
• Patients over 20 years old
• Patients with Zubrod (ECOG) performance status 0-1 within 1 week prior to participation in the study
• Patients who have signed the consent form with sufficient information by the patient or guardian
• Patients with hematologic findings capable of concurrent chemoradiotherapy

You may not qualify if:

• Patients with previous pelvic radiotherapy history
• Pregnant or lactating patients
• Patients with distant metastasis
• Patients judged to be difficult to conserve bladder due to extensive non-invasive/invasive bladder cancer
• Patients who have not been disease-free for more than 5 years after diagnosis of cancer (excluding thyroid cancer, non-melanoma skin cancer, T1a prostate cancer, and intraepithelial cancer of the cervix)
• Patients with untreated severe acute disease
• Patients predicted to have a high probability of radiation complications due to connective tissue disease (lupus, scleroderma, etc.)

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

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

Central Study Contacts

Won Park, Dr

CONTACT

82-10-9933-2616; wonro.park@samsung.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: July 12, 2022
• Study Start: May 14, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 2, 2024

Record last verified: 2024-11

Locations

KR (1)