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Stereotactic Radiotherapy (SBRT) in Patients With Locally Advanced Pancreatic Cancer (LAPC) (SBRT-PC-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648632
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : April 20, 2022
Sponsor:
Information provided by (Responsible Party):
Per Pfeiffer, Odense University Hospital

Brief Summary:

Stereotactic Radiotherapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC).

A Danish phase II study.


Condition or disease Intervention/treatment Phase
Locally Advanced Pancreatic Cancer Radiation: Stereotactic Radiotherapy Not Applicable

Detailed Description:

Combination chemotherapy (e.g. FOLFIRINOX (5-fluorouracil, irinotecan, oxaliplatin), Gem-Abraxane, Gem-Cap, Gem-S1) is standard of care in patients with LAPC but more and more scientific studies point to the fact that patients without sign of progressive disease (PD) will benefit from additional radiotherapy and especially SBRT.

The sample size is based on Simon's two stages mini-max design. This design ensures early study termination if there is insufficient effect.

A resection rate less than 10% after SBRT is not clinically acceptable. Assuming a significance level at 0.1 (α = 0.1) and a power at 90% (β = 0.10) it can be calculated, that 16 patients should be included in the first part of the study. The enrolment will continue until 16 patients have completed SBRT and have been re-evaluated for resection by CT scan (and endoscopic ultrasonography + laparoscopic ultrasound, if available). If 1 or less out of the first 16 consecutive patients are being resected the investigators will reject our hypotheses and close the study after the first stage of accrual. If 2 or more patients are resected, an additional 9 patients will be accrued in the second stage. If at least 4 out of 25 patients are resected, a true resection rate of 30% cannot be excluded, and the investigators will conclude that the treatment is effective enough to continue with future studies.

To ensure 25 evaluable patients the investigators will include a total of 30 patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Radiotherapy (SBRT) in Patients With Locally Advanced Pancreatic Cancer (LAPC). A Danish Phase II Study
Actual Study Start Date : August 22, 2018
Actual Primary Completion Date : March 31, 2022
Actual Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stereotactic Radiotherapy
50 Gy in 5 fractions within a total of 7 - 8 days
Radiation: Stereotactic Radiotherapy
Patients should be treated with 50 Gy in 5 fractions within a total of 7 - 8 days.




Primary Outcome Measures :
  1. Resection rate for all patients starting SBRT [ Time Frame: 12 month ]
    Resection rate for all patients starting SBRT


Secondary Outcome Measures :
  1. 1 year survival for all patients starting SBRT [ Time Frame: 12 month ]
    1 year survival for all patients starting SBRT

  2. Progression-free survival (PFS) [ Time Frame: 12 month ]
    PFS will be calculated from the date of registration to the date of documented progressive disease

  3. Overall survival (OS) [ Time Frame: 12 month ]
    OS will be calculated from the date of registration to the date of documented progressive disease

  4. Adverse events grade 2-5 (NCI-CTCAE 4.1) [ Time Frame: 12 month ]
    Adverse events grade 2-5 (NCI-CTCAE 4.1)

  5. Surgical complications, including irreversible electroporation (IRE) (Clavien-Dindo) [ Time Frame: 30 days ]
    Complication rate will be gathered.

  6. Mortality [ Time Frame: 30 days ]
    Mortality rate

  7. Mortality [ Time Frame: 90 days ]
    Mortality rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LAPC (Karolinska Type B, C or D1)
  • Cytologically or histologically verified adenocarcinoma/carcinoma
  • Prior combination chemotherapy for 2-6 months (unless contraindicated) and no sign of progressive disease
  • The patient is medically operable (i.e. no co-morbidity which can preclude anaesthesia or surgery)
  • World Health Organization performance status 0-1
  • Age ≥ 18 years
  • Adequate hepatic function: bilirubin <3.0 x Upper Normal Limit, International Normalized Ratio <1.6, Activated Partial Thromboplastin Time < 1,5 x Upper Normal Limit. Patients with obstruction of bile duct or gut must be drained before start of therapy
  • Oral and written informed consent must be obtained prior to registration with planned date of first treatment within 14 days from registration.

Exclusion Criteria:

  • M1 disease
  • Prior radiotherapy to abdominal cavity
  • Pregnancy or breast-feeding. Fertile patients must use adequate contraceptives
  • Severe uncontrolled concomitant illness (e.g. clinically significant cardiac disease or myocardial infarction within 12 months)

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): NCT03648632


Locations
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Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Per Pfeiffer
Investigators
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Principal Investigator: Per Pfeiffer, Professor Odense Universitetshospital
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Responsible Party: Per Pfeiffer, Professor, MD, PhD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03648632    
Other Study ID Numbers: KFE 18.13
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: April 20, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Per Pfeiffer, Odense University Hospital:
Stereotactic Radiotherapy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases