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Trial record 46 of 134 for:    Pancreatic Cancer | ( Map: South Korea )

Intraoperative Radiation Therapy for Resectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03273374
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Ik Jae Lee, Gangnam Severance Hospital

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.

Condition or disease Intervention/treatment Phase
Resectable Pancreatic Adenocarcinoma Radiation: Intraoperative radiation therapy (IORT) Phase 2

Detailed Description:
Treatment outcomes of pancreatic cancer are poor even after surgical resection, thus patients may receive adjuvant chemotherapy or chemoradiotherapy. Intraoperative radiotherapy (IORT) with low energy (50 kV) x-ray allows delivery of a high dose radiation to the tumor bed during surgery while effectively sparing adjacent critical organs. Another advantage of IORT is that delivery of IORT does not interfere with the scheduled administration of adjuvant chemotherapy or chemoradiotherapy. Here we investigate the efficacy of IORT for patients with resectable pancreatic adenocarcinoma by comparing the local recurrence rate after surical resection and IORT with that of surgical resection alone from the historical control. A total of 42 patients will be enrolled in this phase II trial, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Phase II Study Investigating Efficacy of Intraoperative Radiation Therapy for Resectable Pancreatic Cancer
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IORT group
Intraoperative radiation therapy of 10 Gy delivered during surgery followed by adjuvant gemcitabine chemotherapy
Radiation: Intraoperative radiation therapy (IORT)
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




Primary Outcome Measures :
  1. Local recurrence rate [ Time Frame: 12 months ]
    Local recurrence rate



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. 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

Exclusion Criteria:

  • 1. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273374


Contacts
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Contact: Ik Jae Lee 82-2-2019-3158 ikjae412@yuhs.ac

Locations
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Korea, Republic of
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ik Jae Lee         
Sponsors and Collaborators
Gangnam Severance Hospital
Investigators
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Principal Investigator: Ik Jae Lee Gangnam Severance Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ik Jae Lee, Principal Investigator, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT03273374     History of Changes
Other Study ID Numbers: 3-2017-0171
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms