Intraoperative Radiation Therapy for Resectable Pancreatic Cancer

Sponsor

Yona Cho (Other)

Overall Status

Recruiting

CT.gov ID

NCT05181488

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Resectable Pancreatic Cancer	Radiation: intraoperative radiotherapy, IORT	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Intervention: intraoperative radiotherapyIntervention: intraoperative radiotherapy

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Phase II Study Evaluating the Efficacy of Intraoperative Radiotherapy After Neoadjuvant Chemotherapy in Patients With Resectable Pancreatic Cancer

Actual Study Start Date :

Apr 2, 2020

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IORT group Intraoperative radiation therapy of 10 Gy delivered during surgery followed by adjuvant gemcitabine chemotherapy	Radiation: intraoperative radiotherapy, IORT 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.

Arm

Intervention/Treatment

Experimental: IORT group

Intraoperative radiation therapy of 10 Gy delivered during surgery followed by adjuvant gemcitabine chemotherapy

Radiation: intraoperative radiotherapy, IORT

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.

Outcome Measures

Primary Outcome Measures

3-year local recurrence rate [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.

Secondary Outcome Measures

post-operative complication [3 year after intraoperative radiotherapy]
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.
disease free survival [1 year and 2 year after intraoperative radiotherapy.]
Disease-free survival is defined as the time from intraoperative radiotherapy to recurrence of tumor, death or last patient contact.
Overall survival [1 year and 2 year after intraoperative radiotherapy.]
Overall survival was defined as the time from intraoperative radiotherapy to death or last patient contact.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gangnam Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Yona Cho

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yona Cho, Assistant Professor, Gangnam Severance Hospital

ClinicalTrials.gov Identifier:

NCT05181488

Other Study ID Numbers:

3-2020-0038

First Posted:

Jan 6, 2022

Last Update Posted:

Jan 6, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yona Cho, Assistant Professor, Gangnam Severance Hospital

Pancreatic cancer

Intraoperative radiotherapy

neoadjuvant chemotherapy

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Jan 6, 2022