Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer

January 10, 2023 updated by: Yonsei University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei University Health System, Severance Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Histologically diagnosed adenocarcinoma of the pancreas

  2. Resectable pancreatic cancer at the time of diagnosis

    • Resectable pancreatic cancer refers to cases in which all of the following conditions are met:

      1. If the tumor does not reach the superior mesenteric vein or portal vein, or even if it does, it reaches within 180°
      2. If the tumor does not reach the superior mesenteric artery, celiac artery, or common hepatic artery
      3. 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

Exclusion criteria:

  1. If there is a history of radiation exposure to the abdomen
  2. Pancreatic cancer that cannot be resected
  3. When accompanied by distant metastasis
  4. Patients who are currently judged to be difficult to undergo surgery based on general performance status, bone marrow, and kidney function tests
  5. Patients with active or uncontrolled infection
  6. Patients with uncontrolled heart disease
  7. Pregnant or lactating women
  8. Patients with a history of malignant tumor excluding skin epithelial carcinoma, except for malignant melanoma, stage 0 cervical cancer, and early thyroid cancer
  9. Patients who have been treated for malignant tumors and have been cured for more than 5 years can participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Preoperative SBRT arm
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.
Radiation: Preoperative Stereotactic body radiation therapy (SBRT), Pancreatic resection, Adjuvant Chemotherapy
  1. 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 weeks after the surgical resection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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 EORTC QLQ-C30) Before the start of treatment, immediately after completion, 3 months after treatment, and every 6 months until 2 years thereafter.
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.
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.
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yonsei University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ik Jae Lee, Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4-2022-1062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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