Clinical trial NCT05679583: Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer
Official title: Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer: A Prospective Phase II Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: R0 rate
timeFrame: 2 weeks after the surgical resection
Secondary outcomes:
measure: Disease-free survival
timeFrame: 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.
measure: Local control rate
timeFrame: 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.
measure: Overall survival rate
timeFrame: 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.
measure: Treatment related acute/chronic toxicity (based on CTCAE ver 5.0)
timeFrame: 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.
measure: Quality of life (based on EORTC QLQ-C30)
timeFrame: 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.
measure: Quality of life (based on FACT-Hep)
timeFrame: 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.
measure: Tumor recurrence
timeFrame: 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.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Ik Jae Lee
role: PRINCIPAL_INVESTIGATOR
References: