Bladder CancerHIRACOMNCT05453682
Hypofractionated IMRT With Concurrent Chemotherapy in Muscle-invasive Bladder Cancer (HIRACUM)
A study testing hypo-IMRT in people with Bladder Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- hypo-IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 May 2021to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Won Park, M.D.,Ph.D, +82-2-3410-2616, wonro.park@samsung.com
About this study
Official title: Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Musc Le-invasive Bladder Cancer:
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.
Read the detailed description
For bladder cancer, conventional concurrent chemoradiotherapy is irradiated with a daily radiation dose of 1.8-2.0 Gy each, a total of 64 Gy or more, and the radiation treatment period takes more than 6 weeks in bladder preserving protocol. Concurrent chemoradiotherapy has the advantage of bladder preservation, but gastrointestinal, genitourinary, and hematologic side effects occur in about 5%. Hypofractionated radiotherapy has the advantage of increasing the radiation-biological effect on tumors by reducing the number of treatments instead of increasing the daily dose, and shortening the overall treatment time. On the other hand, hypofractionated radiotherapy can also increase the risk of side effects related to treatment because the radiologic effects on normal tissues also increase. However, the biological effect of radiation on normal tissues can be reduced by applying intensity-modulated radiation therapy in hypofractional radiation therapy to reduce radiation exposure to normal tissues. Clinical studies of concurrent chemotherapy with hypofractionation radiation therapy are still in its insignificant stage.
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.
The 2-year bladder conserving disease-free survival rate after the existing concurrent chemo-radiation therapy is known to be about 55%, and when concurrent chemo-hyofractionated intensity-modulated radiation therapy is performed in invasive bladder cancer, the 2-year bladder conservation disease-free survival rate is expected about 70%. The number of patients required to verify this was 80% power, a significance level of alpha = 0.1, recruitment of patients for 3 years, and taking into account the follow-up observation for 2 years after recruitment, and setting the dropout rate of 15%, a total of 53 patients was necessary.
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
- Being tested
- hypo-IMRT
- Keywords
- bladder cancer, hypofractionated radiotherapy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypo-IMRTRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypo IMRT | Experimental | in muscle invasive bladder cancer, hypofractionated IMRT with chemotherapy Receives: Radiation: hypo-IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
bladder preservation disease-free survival rate
Two-year bladder preservation disease-free survival rate when concurrent chemo-hypofractionated intensity-modulated radiation therapy
Measured: 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
acute toxicity
Measured: 3 months after participation
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0radiation therapy
late toxicity
Measured: 5 years after participation
EORTC QOL-C30 measurement
QoL
Measured: 5 years after participation
2 year disease-free survival when concurrent chemo-hypofractionated intensity-modulated radiation therapy
disease-free survival
Measured: 2 years after participation of all subjects
overall survival when concurrent chemo-hypofractionated intensity-modulated radiation therapy
overall survival
Measured: 5 years after participation of all subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start14 May 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453682
- Sponsor's protocol ID
- SMC-2021-01-026
- Acronym
- HIRACOM
- Status last verified
- Nov 2024
- First submitted
- 29 Dec 2021
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Musc Le-invasive Bladder Cancer:
- ClinicalTrials.gov ID
- NCT05453682
- Acronym / sponsor ID
- HIRACOM / SMC-2021-01-026
- Conditions
- Bladder Cancer
- Keywords
- bladder cancer, hypofractionated radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 14 May 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For bladder cancer, conventional concurrent chemoradiotherapy is irradiated with a daily radiation dose of 1.8-2.0 Gy each, a total of 64 Gy or more, and the radiation treatment period takes more than 6 weeks in bladder preserving protocol. Concurrent chemoradiotherapy has the advantage of bladder preservation, but gastrointestinal, genitourinary, and hematologic side effects occur in about 5%. Hypofractionated radiotherapy has the advantage of increasing the radiation-biological effect on tumors by reducing the number of treatments instead of increasing the daily dose, and shortening the overall treatment time. On the other hand, hypofractionated radiotherapy can also increase the risk of side effects related to treatment because the radiologic effects on normal tissues also increase. However, the biological effect of radiation on normal tissues can be reduced by applying intensity-modulated radiation therapy in hypofractional radiation therapy to reduce radiation exposure to normal tissues. Clinical studies of concurrent chemotherapy with hypofractionation radiation therapy are still in its insignificant stage.
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.
The 2-year bladder conserving disease-free survival rate after the existing concurrent chemo-radiation therapy is known to be about 55%, and when concurrent chemo-hyofractionated intensity-modulated radiation therapy is performed in invasive bladder cancer, the 2-year bladder conservation disease-free survival rate is expected about 70%. The number of patients required to verify this was 80% power, a significance level of alpha = 0.1, recruitment of patients for 3 years, and taking into account the follow-up observation for 2 years after recruitment, and setting the dropout rate of 15%, a total of 53 patients was necessary.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypo IMRT | Experimental | Radiation: hypo-IMRTin muscle invasive bladder cancer, hypofractionated IMRT with chemotherapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypo-IMRTTwenty 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. | Radiation | Hypo IMRT |
Primary outcome
bladder preservation disease-free survival rate
Time frame: 2 years after participation of all subjects
Two-year bladder preservation disease-free survival rate when concurrent chemo-hypofractionated intensity-modulated radiation therapy
5 secondary outcomes
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
Time frame: 3 months after participation
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0radiation therapy
Time frame: 5 years after participation
EORTC QOL-C30 measurement
Time frame: 5 years after participation
2 year disease-free survival when concurrent chemo-hypofractionated intensity-modulated radiation therapy
Time frame: 2 years after participation of all subjects
overall survival when concurrent chemo-hypofractionated intensity-modulated radiation therapy
Time frame: 5 years after participation of all subjects
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypo-IMRT in people with Bladder Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Won Park, Dr (82-10-9933-2616, wonro.park@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bladder preservation disease-free survival rate (time frame: 2 years after participation of all subjects). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.