NCT02599662

Brief Summary

Currently, for patients with pancreatic cancer the standard treatment is surgery followed by chemotherapy and/or radiation therapy. An investigational approach is to perform the surgery and treat the area of the tumor with intraoperative radiotherapy in one procedure. Intraoperative radiation delivers low energy x-rays to a targeted area during the time of tumor removal. The purpose of this study is to learn about both the good and bad effects of adding intraoperative radiation therapy. Another goal is to determine and compare the quality of life before and after the procedure. We will also monitor the effect of the therapy on the cancer lesion and any complications that may result.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

7 years

First QC Date

November 5, 2015

Last Update Submit

June 3, 2020

Conditions

Pancreas Cancer

Keywords

CancerIntraoperative Radiation Therapy - IORT

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose

    Maximum Tolerated Dose as defined by Radiation-related acute Grade 3-5 toxicity in greater than or equal to 2 patients out of 6 patients at any dose level

    52 weeks

Secondary Outcomes (1)

  • QOL surveys

    52 weeks

Study Arms (3)

Group 1: 10 Gy Low-KV IORT

OTHER

10 Gy Low Kilovoltage Intraoperative Radiation: intraoperative low-kV IORT will be delivered as a single dose of 10 Gy at 2 millimeter depth. Doses will be escalated in increments of 5 Gy until completion of 20 Gy dose level or the DLT is reached and MTD is realized.

Radiation: 10 Gy Low-KV IORT

Group 2: 15 Gy Low-KV IORT

OTHER

15 Gy Low Kilovoltage Intraoperative Radiation: intraoperative low-kV IORT will be delivered as a single dose of 15 Gy at 2 millimeter depth. Doses will be escalated in increments of 5 Gy until completion of 20 Gy dose level or the DLT is reached and MTD is realized.

Radiation: 15 Gy Low-KV IORT

Group 3: 20 GY Low-KV IORT

OTHER

20 GY Low Kilovoltage Intraoperative Radiation: intraoperative low-kV IORT will be delivered as a single dose of 20 Gy at 2 millimeter depth. Patients will be accrued to this group until the DLT is reached and MTD is realized.

Radiation: 20 GY Low-KV IORT

Interventions

10 Gy Low-KV IORTRADIATION

: intraoperative low-kV IORT will be delivered as a single dose of 10 Gy at 2 millimeter depth. Doses will be escalated in increments of 5 Gy until completion of 20 Gy dose level or the DLT is reached and MTD is realized.

Group 1: 10 Gy Low-KV IORT
15 Gy Low-KV IORTRADIATION

intraoperative low-kV IORT will be delivered as a single dose of 15 Gy at 2 millimeter depth. Doses will be escalated in increments of 5 Gy until completion of 20 Gy dose level or the DLT is reached and MTD is realized.

Group 2: 15 Gy Low-KV IORT
20 GY Low-KV IORTRADIATION

intraoperative low-kV IORT will be delivered as a single dose of 20 Gy at 2 millimeter depth. Patients will be accrued to this group until the DLT is reached and MTD is realized.

Group 3: 20 GY Low-KV IORT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed pancreatic adenocarcinoma.
  • Age ≥ 18 years.
  • Performance status ECOG 0-1.
  • Patient 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 and stage II disease per AJCC 7th edition.
  • Complete history and physical examination including weight and ECOG performance status within 31 days of entry.
  • Laboratory data obtained ≤ 14 days prior to registration on study, with adequate bone marrow and organ function defined as follows:
  • Laboratory Test Result Leukocytes ≥3000/mm3 Absolute Neutrophil Count (ANC) ≥1500/mm3 Platelets ≥100,000/mm3 Total Bilirubin ≤1.4 mg/dL AST(SGOT),ALT(SPGT) ≤2.5 x institutional upper limit of normal Serum creatinine ≤1.4 mg/dL INR ≤1.5 BUN \< 20 mg/dL Albumin ≥3.5 g/dL
  • Negative serum pregnancy test for females of childbearing potential within 14 days of study registration. Should a female participant become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months.
  • +7 more criteria

You may not qualify if:

  • Defined treatment area which cannot be adequately covered by the radiation field as defined by the radiation oncology treatment team.
  • Patients who have received neoadjuvant chemotherapy are ineligible.
  • Patients with Stage III-Stage IV disease.
  • Patients who have been on an immunosuppressive agent (excluding corticosteroids) within 4 weeks of the proposed operation.
  • Patients receiving any other investigational agents.
  • Current pregnancy or currently nursing.
  • History of brain metastases.
  • Severe, active comorbidity defined as follows
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months. \[23\]
  • Myocardial infarction within 3 months of study registration \[23\].
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
  • Chronic Obstructive Pulmonary Disease or other respiratory illness hospitalization or precluding study therapy at time of registration \[23\].
  • Uncontrolled diabetes which in the opinion of any of the patient's physicians requires an immediate change in management. A patient may be considered eligible if the patient's physician managing the diabetes deems the appropriate changes in management have resulted in adequate control. \[23\].
  • BMI \>30.
  • Patient with active diagnosis of a bleeding disorder. \[23\]
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Related Publications (13)

  • Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.

    PMID: 23335087BACKGROUND

  • Kalser MH, Ellenberg SS. Pancreatic cancer. Adjuvant combined radiation and chemotherapy following curative resection. Arch Surg. 1985 Aug;120(8):899-903. doi: 10.1001/archsurg.1985.01390320023003.

    PMID: 4015380BACKGROUND

  • Mohammed S, Van Buren G 2nd, Fisher WE. Pancreatic cancer: advances in treatment. World J Gastroenterol. 2014 Jul 28;20(28):9354-60. doi: 10.3748/wjg.v20.i28.9354.

    PMID: 25071330BACKGROUND

  • Nagakawa T, Kayahara M, Ohta T, Ueno K, Konishi I, Miyazaki I. Patterns of neural and plexus invasion of human pancreatic cancer and experimental cancer. Int J Pancreatol. 1991 Oct;10(2):113-9. doi: 10.1007/BF02924114.

    PMID: 1660909BACKGROUND

  • Gnerlich JL, Luka SR, Deshpande AD, Dubray BJ, Weir JS, Carpenter DH, Brunt EM, Strasberg SM, Hawkins WG, Linehan DC. Microscopic margins and patterns of treatment failure in resected pancreatic adenocarcinoma. Arch Surg. 2012 Aug;147(8):753-60. doi: 10.1001/archsurg.2012.1126.

    PMID: 22911074BACKGROUND

  • Iqbal N, Lovegrove RE, Tilney HS, Abraham AT, Bhattacharya S, Tekkis PP, Kocher HM. A comparison of pancreaticoduodenectomy with extended pancreaticoduodenectomy: a meta-analysis of 1909 patients. Eur J Surg Oncol. 2009 Jan;35(1):79-86. doi: 10.1016/j.ejso.2008.01.002. Epub 2008 Mar 19.

    PMID: 18356005BACKGROUND

  • Hiraoka T. Extended radical resection of cancer of the pancreas with intraoperative radiotherapy. Baillieres Clin Gastroenterol. 1990 Dec;4(4):985-93. doi: 10.1016/0950-3528(90)90031-b. No abstract available.

    PMID: 2078795BACKGROUND

  • Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

    PMID: 21561347BACKGROUND

  • Wood WC, Shipley WU, Gunderson LL, Cohen AM, Nardi GL. Intraoperative irradiation for unresectable pancreatic carcinoma. Cancer. 1982 Mar 15;49(6):1272-5. doi: 10.1002/1097-0142(19820315)49:63.0.co;2-e.

    PMID: 6800633BACKGROUND

  • Shipley WU, Wood WC, Tepper JE, Warshaw AL, Orlow EL, Kaufman SD, Battit GE, Nardi GL. Intraoperative electron beam irradiation for patients with unresectable pancreatic carcinoma. Ann Surg. 1984 Sep;200(3):289-96. doi: 10.1097/00000658-198409000-00006.

    PMID: 6205632BACKGROUND

  • Kawai M, Yamaue H. Analysis of clinical trials evaluating complications after pancreaticoduodenectomy: a new era of pancreatic surgery. Surg Today. 2010 Nov;40(11):1011-7. doi: 10.1007/s00595-009-4245-9. Epub 2010 Nov 3.

    PMID: 21046497BACKGROUND

  • Parikh P, Shiloach M, Cohen ME, Bilimoria KY, Ko CY, Hall BL, Pitt HA. Pancreatectomy risk calculator: an ACS-NSQIP resource. HPB (Oxford). 2010 Sep;12(7):488-97. doi: 10.1111/j.1477-2574.2010.00216.x.

    PMID: 20815858BACKGROUND

  • Lermite E, Sommacale D, Piardi T, Arnaud JP, Sauvanet A, Dejong CH, Pessaux P. Complications after pancreatic resection: diagnosis, prevention and management. Clin Res Hepatol Gastroenterol. 2013 Jun;37(3):230-9. doi: 10.1016/j.clinre.2013.01.003. Epub 2013 Feb 14.

    PMID: 23415988BACKGROUND

MeSH Terms

Conditions

Pancreatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Central Study Contacts

Beth Chiappetta, BSN

CONTACT

708-216-2568bchiappetta@lumc.edu

Tarita Thomas, MD, PhD

CONTACT

708-216-2571tathomas@lumc.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Radiation Oncology

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 6, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

June 4, 2020

Record last verified: 2020-06

Locations

US(1)