NCT03273374

Brief Summary

This phase II study is designed to investigate the efficacy of IORT for patients with resectable pancreatic adenocarcinoma. The purpose of the study is to show the local recurrence rate after surgical resection and IORT is superior to that of surgical resection alone from the historical control. A total of 42 patients will be enrolled, and these patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed, followed by 6 cycles of adjuvant gemcitabine chemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2022

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

3 years

First QC Date

September 3, 2017

Last Update Submit

September 11, 2023

Conditions

Resectable Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Local recurrence rate

    Local recurrence rate

    12 months

Study Arms (1)

IORT group

EXPERIMENTAL

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

Device: Intraoperative radiation therapy (IORT)

Interventions

Intraoperative radiation therapy (IORT)DEVICE

IORT with 50 kV x-ray will be delivered during surgery as a single dose of 10 Gy at 5 millimeter depths of the tumor bed, followed by gemcitabine chemotherapy (1000 mg/m2) every 4 weeks for a total of 6 cycles

IORT group

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Pathologically confirmed pancreatic adenocarcinoma 2. Age ≥20 years 3. Performance status ECOG 0-2 4. Patients must have resectable disease. In order to be resectable the following criteria must be met:
  • Absence of distant metastases
  • Clear fat planes around the celiac axis, hepatic artery, and superior mesenteric artery
  • Absence of direct involvement of inferior vena cava or aorta
  • Stage I-III disease per AJCC 7th edition 5. Laboratory data obtained ≤14 days prior to registration on study, with adequate bone marrow and renal function defined as follows:
  • Hemoglobin \>10 g/dL, Absolute Neutrophil Count (ANC) \>1,500/mm3, Platelets \>100,000/mm3
  • Serum Cr \<1.4 mg/dL, BUN \<20 mg/dL 6. Ability to understand and the willingness to sign a written informed consent

You may not qualify if:

  • \. Patients who have received external beam radiotherapy in the abdominal area 2. Defined treatment area which cannot be adequately covered by the radiation field as defined by the radiation oncology treatment team 3. Patients who have received neoadjuvant chemotherapy 4. Stage IV disease 5. Patients with distant metastases 6. Current pregnancy or currently nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

Location

Related Publications (3)

  • Cho Y, Kim JW, Kim HS, Park JS, Lee IJ. Intraoperative Radiotherapy for Resectable Pancreatic Cancer Using a Low-Energy X-Ray Source: Postoperative Complications and Early Outcomes. Yonsei Med J. 2022 May;63(5):405-412. doi: 10.3349/ymj.2022.63.5.405.

    PMID: 35512742DERIVED

  • Lee YS, Kim HS, Cho Y, Lee IJ, Kim HJ, Lee DE, Kang HW, Park JS. Intraoperative radiation therapy induces immune response activity after pancreatic surgery. BMC Cancer. 2021 Oct 12;21(1):1097. doi: 10.1186/s12885-021-08807-3.

    PMID: 34641806DERIVED

  • Kim JW, Cho Y, Kim HS, Choi WH, Park JS, Lee IJ. A phase II study of intraoperative radiotherapy using a low-energy x-ray source for resectable pancreatic cancer: a study protocol. BMC Surg. 2019 Mar 7;19(1):31. doi: 10.1186/s12893-019-0492-x.

    PMID: 30845939DERIVED

Study Officials

  • Ik Jae Lee

    Gangnam Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Intervention: intraoperative radiotherapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 3, 2017

First Posted

September 6, 2017

Study Start

August 14, 2017

Primary Completion

August 21, 2020

Study Completion

August 22, 2022

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations

KR(1)