Pancreatic CancerPhase 2NCT05679583
Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer
A Phase 2 study testing Preoperative Stereotactic body radiation therapy (SBRT), Pancreatic resection, Adjuvant Chemotherapy in people with Pancreatic Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Pancreatic cancer is a cancer with a poor prognosis and a high mortality rate. The prognosis of surgically resectable pancreatic cancer is better than that of unresectable pancreatic cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Preoperative Stereotactic body radiation therapy (SBRT), Pancreatic resection, Adjuvant Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Sep 2022to 25 Sep 2026
- Phase
- Phase 2
- 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 adenocarcinoma of the pancreas
- Resectable pancreatic cancer at the time of diagnosis
- Resectable pancreatic cancer refers to cases in which all of the following conditions are met:
- If the tumor does not reach the superior mesenteric vein or portal vein, or even if it does, it reaches within 180°
- If the tumor does not reach the superior mesenteric artery, celiac artery, or common hepatic artery
- In the absence of distant metastases 3) Patients aged 20 years or older at the time of diagnosis 4) General performance status is 0-2 based on the Eastern Cooperative Oncology Group (ECOG) standard 5) Patients who voluntarily decided to participate in this clinical study and signed the written informed consent
Who cannot join
- If there is a history of radiation exposure to the abdomen
- Pancreatic cancer that cannot be resected
- When accompanied by distant metastasis
- Patients who are currently judged to be difficult to undergo surgery based on general performance status, bone marrow, and kidney function tests
- Patients with active or uncontrolled infection
- Patients with uncontrolled heart disease
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- Pregnant or lactating women
- Patients with a history of malignant tumor excluding skin epithelial carcinoma, except for malignant melanoma, stage 0 cervical cancer, and early thyroid cancer
- Patients who have been treated for malignant tumors and have been cured for more than 5 years can participate in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Ik Jae Lee, +82-2-2228-8117, IKJAE412@YUHS.AC
About this study
Official title: Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer: A Prospective Phase II Study
Pancreatic cancer is a cancer with a poor prognosis and a high mortality rate. The prognosis of surgically resectable pancreatic cancer is better than that of unresectable pancreatic cancer. But the prognosis is still poor enough to report a 2-year disease-free survival rate of 47.0% despite the application of standard treatment. Preoperative chemotherapy or radiotherapy for pancreatic cancer has been performed for a long time, especially for locally advanced pancreatic cancer. However, there are very few studies on the application of preoperative chemotherapy or radiotherapy for borderline resectable or resectable pancreatic cancer. The PREOPANC trial is a representative randomized study to investigate the effect of preoperative chemo/radiation therapy in borderline resectable or resectable pancreatic cancer. As a result, the overall survival, progression-free survival, local control, and distant control rates were significantly superior in preoperative therapy group. However, when only patients with resectable pancreatic cancer were analyzed separately, there was no significant difference in overall survival rate or complete resection rate. In 2020, retrospective propensity score matching analysis using the national cancer database revealed that the addition of preoperative stereotactic body radiation therapy (SBRT) showed a significant increase in overall survival rate rather than preoperative chemotherapy alone. In addition, SBRT also showed a significant increase in overall survival rather than conventional fractionated RT. In summary, the current standard treatment for resectable pancreatic cancer is surgical resection, but a higher survival rate can be expected when preoperative therapy is added. However, there is no study that focused on the role of preoperative SBRT. Therefore, this study aims to confirm the effectiveness of adding preoperative SBRT alone in resectable pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- Preoperative Stereotactic body radiation therapy (SBRT), Pancreatic resection, Adjuvant 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.
Preoperative Stereotactic body radiation therapy (SBRT), Pancreatic resection, Adjuvant ChemotherapyRadiation
- Preoperative Stereotactic body radiation therapy (SBRT) For the gross pancreatic cancer lesion, 30 Gy/5 fx will be prescribed considering respiratory movement. And 20 Gy/5 fx will be prescribed to the triangle operation area including the common hepatic artery, celiac artery, and portal vein.
- Pancreatic resection Surgical resection will be performed 2-4 weeks after the end of radiation therapy. The surgical method and resection range depend on the surgeon's judgment at the time of surgery.
- Adjuvant Chemotherapy Adjuvant chemotherapy will be given under the judgment of the oncologist from 4 weeks after surgical resection, considering the pathological findings (R0 or R1 resection status, etc.) and the patient's medical condition. Adjuvant chemotherapy includes gemcitabine alone, gemcitabine plus capecitabine combination therapy, and mFOLFIRINOX.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative SBRT arm | Experimental | Patients with resectable pancreatic cancer will receive preoperative SBRT 2 to 4 weeks before surgery. And 4 weeks after surgery, adjuvant CTx will be administered for 6 months. Receives: Radiation: Preoperative Stereotactic body radiation therapy (SBRT), Pancreatic resection, Adjuvant Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 rate
R0 resection is defined as the resection margin more than 1 mm away from the tumor on histological findings after pancreatic cancer surgery. The R0 rate refers to the proportion of patients showing R0 resection, based on all patients.
Measured: 2 weeks after the surgical resection
Secondary outcomes (7)
Disease-free survival
Disease-free survival It is based on the time from the date when pancreatic cancer was first diagnosed histologically to the time when recurrence was confirmed on clinical or radiological examination or when the subject died.
Measured: Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years.
Local control rate
Local control rate It is based on the time from the date when pancreatic cancer was first diagnosed histologically to the time when local recurrence was confirmed on clinical and radiological examination.
Measured: Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years.
Overall survival rate
Overall survival rate It is based on the date from the date of the first histological diagnosis of pancreatic cancer to the date of death of the subject or the date of the last follow-up.
Measured: Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years.
Treatment related acute/chronic toxicity (based on CTCAE ver 5.0)
Treatment related acute/chronic toxicity (based on CTCAE ver 5.0) During treatment, immediately after the end of treatment, 3 months after treatment, and at 6-month intervals thereafter, CTCAE 5.0 is measured.
Measured: Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years.
Quality of life (based on EORTC QLQ-C30)
Quality of life (based on EORTC QLQ-C30) Before the start of treatment, immediately after completion, 3 months after treatment, and every 6 months until 2 years thereafter.
Measured: Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years.
Quality of life (based on FACT-Hep)
Quality of life (based on FACT-Hep) Before the start of treatment, immediately after completion, 3 months after treatment, and every 6 months until 2 years thereafter.
Measured: Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years.
Tumor recurrence
Tumor recurrence Imaging tests and tumor marker tests are performed every 3-6 months after treatment to determine the presence or absence of tumor recurrence.
Measured: Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start26 Sep 2022
- Primary completion25 Sep 2026 (estimated)
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ik Jae Lee, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679583
- Sponsor's protocol ID
- 4-2022-1062
- Status last verified
- Dec 2022
- First submitted
- 25 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer: A Prospective Phase II Study
- ClinicalTrials.gov ID
- NCT05679583
- Acronym / sponsor ID
- 4-2022-1062
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 11 Jan 2023 (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.
Pancreatic cancer is a cancer with a poor prognosis and a high mortality rate. The prognosis of surgically resectable pancreatic cancer is better than that of unresectable pancreatic cancer. But the prognosis is still poor enough to report a 2-year disease-free survival rate of 47.0% despite the application of standard treatment. Preoperative chemotherapy or radiotherapy for pancreatic cancer has been performed for a long time, especially for locally advanced pancreatic cancer. However, there are very few studies on the application of preoperative chemotherapy or radiotherapy for borderline resectable or resectable pancreatic cancer. The PREOPANC trial is a representative randomized study to investigate the effect of preoperative chemo/radiation therapy in borderline resectable or resectable pancreatic cancer. As a result, the overall survival, progression-free survival, local control, and distant control rates were significantly superior in preoperative therapy group. However, when only patients with resectable pancreatic cancer were analyzed separately, there was no significant difference in overall survival rate or complete resection rate. In 2020, retrospective propensity score matching analysis using the national cancer database revealed that the addition of preoperative stereotactic body radiation therapy (SBRT) showed a significant increase in overall survival rate rather than preoperative chemotherapy alone. In addition, SBRT also showed a significant increase in overall survival rather than conventional fractionated RT. In summary, the current standard treatment for resectable pancreatic cancer is surgical resection, but a higher survival rate can be expected when preoperative therapy is added. However, there is no study that focused on the role of preoperative SBRT. Therefore, this study aims to confirm the effectiveness of adding preoperative SBRT alone in resectable pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative SBRT arm | Experimental | Radiation: Preoperative Stereotactic body radiation therapy (SBRT), Pancreatic resection, Adjuvant ChemotherapyPatients with resectable pancreatic cancer will receive preoperative SBRT 2 to 4 weeks before surgery. And 4 weeks after surgery, adjuvant CTx will be administered for 6 months. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically diagnosed adenocarcinoma of the pancreas
- Resectable pancreatic cancer at the time of diagnosis
Key exclusion criteria (9 listed)
- If there is a history of radiation exposure to the abdomen
- Pancreatic cancer that cannot be resected
- When accompanied by distant metastasis
- Patients who are currently judged to be difficult to undergo surgery based on general performance status, bone marrow, and kidney function tests
- Patients with active or uncontrolled infection
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 |
|---|---|---|
| Preoperative Stereotactic body radiation therapy (SBRT), Pancreatic resection, Adjuvant Chemotherapy1. Preoperative Stereotactic body radiation therapy (SBRT) For the gross pancreatic cancer lesion, 30 Gy/5 fx will be prescribed considering respiratory movement. And 20 Gy/5 fx will be prescribed to the triangle operation area including the common hepatic artery, celiac artery, and portal vein. 2. Pancreatic resection Surgical resection will be performed 2-4 weeks after the end of radiation therapy. The surgical method and resection range depend on the surgeon's judgment at the time of surgery. 3. Adjuvant Chemotherapy Adjuvant chemotherapy will be given under the judgment of the oncologist from 4 weeks after surgical resection, considering the pathological findings (R0 or R1 resection status, etc.) and the patient's medical condition. Adjuvant chemotherapy includes gemcitabine alone, gemcitabine plus capecitabine combination therapy, and mFOLFIRINOX. | Radiation | Preoperative SBRT arm |
Primary outcome
R0 rate
Time frame: 2 weeks after the surgical resection
R0 resection is defined as the resection margin more than 1 mm away from the tumor on histological findings after pancreatic cancer surgery. The R0 rate refers to the proportion of patients showing R0 resection, based on all patients.
7 secondary outcomes
Disease-free survival
Time frame: Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years.
Local control rate
Time frame: Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years.
Overall survival rate
Time frame: Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years.
Treatment related acute/chronic toxicity (based on CTCAE ver 5.0)
Time frame: Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years.
Quality of life (based on EORTC QLQ-C30)
Time frame: Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years.
Quality of life (based on FACT-Hep)
Time frame: Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years.
Tumor recurrence
Time frame: Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Ik Jae Lee principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Preoperative Stereotactic body radiation therapy (SBRT), Pancreatic resection, Adjuvant Chemotherapy in people with Pancreatic Cancer, run by Yonsei University 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 6 inclusion and 9 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 11 Jan 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Ik Jae Lee (+82-2-2228-8117, IKJAE412@YUHS.AC), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 rate (time frame: 2 weeks after the surgical resection). 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 11 Jan 2023.