Resectable Pancreatic CancerNCT05181488
Intraoperative Radiation Therapy for Resectable Pancreatic Cancer
A study testing intraoperative radiotherapy, IORT in people with Resectable Pancreatic Cancer, run by Yona Cho at 1 site in South Korea.
Trial summary
This phase II study is designed to investigate the efficacy of intraoperative radiotherapy after neoadjuvant chemotherapy in patients with resectable pancreatic cancer. The purpose of the study is to show the local recurrence rate after neoadjuvant chemotherapy and IORT is superior to that of surgical resection alone… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Resectable Pancreatic Cancer
- What is being tested?
- intraoperative radiotherapy, IORT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Apr 2020to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Histologically diagnosed with adenocarcinoma of the pancreas or clinically diagnosed with imaging examinations or tumor markers
- 20 years or older
- Performance status 0-2 based on Eastern Cooperative Oncology Group (ECOG)
- Patients with surgically resectable or borderline resectable and advanced pancreatic cancer that can be resected after neoadjuvant chemotherapy
- Patients who voluntarily decided to participate in this clinical study and signed a written informed consent
Who cannot join
- History of previous abdominal irradiation.
- When the treatment area is not included in the appropriate radiation field according to the judgment of the radiation oncologist or Durgeon
- Distant metastasis
- Other systemic conditions that, under the judgment of the attending physician, would be difficult to undergo surgery or radiiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Phase II Study Evaluating the Efficacy of Intraoperative Radiotherapy After Neoadjuvant Chemotherapy in Patients With Resectable Pancreatic Cancer
This phase II study is designed to investigate the efficacy of intraoperative radiotherapy after neoadjuvant chemotherapy in patients with resectable pancreatic cancer. The purpose of the study is to show the local recurrence rate after neoadjuvant chemotherapy and IORT is superior to that of surgical resection alone from the historical control. A total of 80 patients will be enrolled, and these patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed, following neoadjuvant chemotherapy.
- Conditions
- Resectable Pancreatic Cancer
- Being tested
- intraoperative radiotherapy, IORT
- Keywords
- Pancreatic cancer, Intraoperative radiotherapy, neoadjuvant chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative radiotherapy, IORTRadiation
A dose of 10 Gy is prescribed to be irradiated at a depth of 5 mm from the surface of the applicator, and the radiation oncologist determines the exact irradiation time. The irradiation time may take 20 to 60 minutes depending on the size of the applicator, and the exact irradiation time is calculated after checking the quality assurance of the radiation generator before treatment every day.
| Study group | Role | What they receive |
|---|---|---|
| IORT group | Experimental | Intraoperative radiation therapy of 10 Gy delivered during surgery followed by adjuvant gemcitabine chemotherapy Receives: Radiation: intraoperative radiotherapy, IORT |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year local recurrence rate
A local recurrence is defined as reappearance of cancer in the ipsilateral preserved breast or chest wall.
The 3-year local recurrence rate is calculated using the Kaplan-Meier method.
Measured: 3 year after intraoperative radiotherapy
Secondary outcomes (3)
post-operative complication
Evaluation of safety, including adverse events, was performed by the Principal Investigator and delegated participating investigators in the Department of Surgery and Radiation Oncology outpatient clinic.
Toxicity is evaluated within 3 months (acute) and thereafter (chronic) after surgery, and it is performed through a questionnaire and physical examination at every visit up to 1 year after surgery and recorded.
Measured: 3 year after intraoperative radiotherapy
disease free survival
Disease-free survival is defined as the time from intraoperative radiotherapy to recurrence of tumor, death or last patient contact.
Measured: 1 year and 2 year after intraoperative radiotherapy.
Overall survival
Overall survival was defined as the time from intraoperative radiotherapy to death or last patient contact.
Measured: 1 year and 2 year after intraoperative radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start2 Apr 2020
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Model description
- Intervention: intraoperative radiotherapy
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yona Cho
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yona Cho, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181488
- Sponsor's protocol ID
- 3-2020-0038
- Status last verified
- Apr 2024
- First submitted
- 5 Dec 2021
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Phase II Study Evaluating the Efficacy of Intraoperative Radiotherapy After Neoadjuvant Chemotherapy in Patients With Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05181488
- Acronym / sponsor ID
- 3-2020-0038
- Conditions
- Resectable Pancreatic Cancer
- Keywords
- Pancreatic cancer, Intraoperative radiotherapy, neoadjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yona ChoUniversity, hospital or other
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 6 Jan 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.
This phase II study is designed to investigate the efficacy of intraoperative radiotherapy after neoadjuvant chemotherapy in patients with resectable pancreatic cancer. The purpose of the study is to show the local recurrence rate after neoadjuvant chemotherapy and IORT is superior to that of surgical resection alone from the historical control. A total of 80 patients will be enrolled, and these patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed, following neoadjuvant chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention: intraoperative radiotherapy
| Arm | Type | Receives |
|---|---|---|
| IORT group | Experimental | Radiation: intraoperative radiotherapy, IORTIntraoperative radiation therapy of 10 Gy delivered during surgery followed by adjuvant gemcitabine chemotherapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically diagnosed with adenocarcinoma of the pancreas or clinically diagnosed with imaging examinations or tumor markers
- 20 years or older
- Performance status 0-2 based on Eastern Cooperative Oncology Group (ECOG)
- Patients with surgically resectable or borderline resectable and advanced pancreatic cancer that can be resected after neoadjuvant chemotherapy
- Patients who voluntarily decided to participate in this clinical study and signed a written informed consent
Key exclusion criteria (4 listed)
- History of previous abdominal irradiation.
- When the treatment area is not included in the appropriate radiation field according to the judgment of the radiation oncologist or Durgeon
- Distant metastasis
- Other systemic conditions that, under the judgment of the attending physician, would be difficult to undergo surgery or radiiotherapy
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 |
|---|---|---|
| intraoperative radiotherapy, IORTA dose of 10 Gy is prescribed to be irradiated at a depth of 5 mm from the surface of the applicator, and the radiation oncologist determines the exact irradiation time. The irradiation time may take 20 to 60 minutes depending on the size of the applicator, and the exact irradiation time is calculated after checking the quality assurance of the radiation generator before treatment every day. | Radiation | IORT group |
Primary outcome
3-year local recurrence rate
Time frame: 3 year after intraoperative radiotherapy
A local recurrence is defined as reappearance of cancer in the ipsilateral preserved breast or chest wall. The 3-year local recurrence rate is calculated using the Kaplan-Meier method.
3 secondary outcomes
post-operative complication
Time frame: 3 year after intraoperative radiotherapy
disease free survival
Time frame: 1 year and 2 year after intraoperative radiotherapy.
Overall survival
Time frame: 1 year and 2 year after intraoperative radiotherapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraoperative radiotherapy, IORT in people with Resectable Pancreatic Cancer, run by Yona Cho 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year local recurrence rate (time frame: 3 year after intraoperative radiotherapy). 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 15 Apr 2024.