Safety of Cyberknife in Patients With Borderline Resectable or Locally Advanced Pancreatic Adenocarcinoma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapital Health System, Inc

About this trial

The hypothesize that SBRT will limit or reverse tumor growth and thereby convert the borderline resectable disease or locally advanced disease in to a resectable tumor. Furthermore, we want to assess whether SBRT leads to an improved quality of life compared to IMRT.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to sign the informed consent and understand the consenting process

Completed neoadjuvant chemotherapy regimen

Patient is 18 years of age and older

Eastern Cooperative Oncology Group (ECOG) Status of 0-1.

Disqualifiers

Pregnant or lactating female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of radiation therapy.

Resectable pancreatic cancer (See addendum, NCCN Guidelines 2021, PANC-2)

Unresectable pancreatic cancer (See addendum, NCCN Guidelines 2021, PANC-6)

Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cyberknife

    Radiation

    5-10 Gy/fraction.Average of 45 minutes every other day for a total of 5 sessions (1.5-2 weeks).

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: SBRT (Cyberknife)Experimental treatment 1 intervention
Group B: IMRTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Resectability

Occurrence of meeting resectability criteria using NCCN (PAN-C) guidelines

Time frame
1 month after the completion of radiation therapy.

Secondary outcomes

1

Patient Reported Outcome (General) - European Organization for Research and Treatment of Cancer (EORTC).

Change in mean score from baseline of Quality of Life using EORTC QLQ-C30 questionnaire. Raw score is transformed to standardize with a lowest value of 0 and a highest of 100.

Time frame
at baseline and then at 3 month intervals.
2

Patient Reported Outcome (Specific)European Organization for Research and Treatment of Cancer (EORTC).

Change in mean score from baseline of Quality of Life using EORTC PAN26 questionnaire. Raw score is transformed to standardize with a lowest value of 0 and a highest of 100.

Time frame
At baseline and then at 3 month intervals.

Other outcomes

Sponsors and contacts

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