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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2022
  • participants needed
    30
  • sponsor
    Per Pfeiffer
Updated on 26 January 2021

Summary

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

A Danish phase II study.

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 ( = 0.1) and a power at 90% ( = 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.

Details
Condition Locally Advanced Pancreatic Cancer
Treatment Stereotactic radiotherapy
Clinical Study IdentifierNCT03648632
SponsorPer Pfeiffer
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note