An interventional study of Cyberknife in Pancreas Adenocarcinoma, sponsored by Capital Health System, Inc. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-31.
Sponsored by Capital Health System, Inc · Not applicable, Interventional, and Other
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.
The study is an open-label, longitudinal, prospective randomized, superiority clinical trial. The protocol applies to patients with confirmed diagnosis of pancreatic adenocarcinoma and pancreatic protocol CT scan showing borderline resectable disease or locally advanced disease as per the NCCN guidelines (See addendum, NCCN Guidelines 2021, PANC-3 and PANC-4). All cases will be discussed at the multidisciplinary GI cancer conference (tumor board). Cases will continue to be reviewed at different milestones of their treatment as described below.
Patients diagnosed with borderline resectable or locally advanced pancreatic cancer will receive standard of care and neoadjuvant chemotherapy according to NCCN guidelines and protocols followed by radiation therapy. The radiation therapy will start 4 weeks after ending the chemotherapy, thereby creating a wash-out period. At the start of the radiation therapy subjects will be consented and randomized into either receiving the IMRT protocol or the SBRT protocol. Baseline measurements will be collected at the start of the radiation treatment. At the completion of the radiation therapy the subject's progress and condition will be evaluated by the tumor board and a multidisciplinary consensus agreement will be reached to decide the course of further treatment, which could be chemotherapy (if deemed unresectable) or proceed with surgery (if deemed resectable). Irrespective the decision, patients will be asked to return for follow up every 3 months to obtain CT scans, assess quality of life and provide a biological sample (blood) for up to 12 months after the initiation of the radiation therapy.
2,004 studies on the registry are indexed under Adenocarcinoma; 374 are open to participants now.
This study's planned enrollment of 10 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →This is the only study on the registry with Capital Health System, Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
5-10 Gy/fraction. Average of 45 minutes every other day for a total of 5 sessions (1.5-2 weeks).
Radiation: Cyberknife
1.2-3 Gy/fraction up to 40 fractions. 15 mins daily (M-F) for a total of 28 sessions (5.5 weeks).
Radiation: Cyberknife
5-10 Gy/fraction.Average of 45 minutes every other day for a total of 5 sessions (1.5-2 weeks).
Resectability
Occurrence of meeting resectability criteria using NCCN (PAN-C) guidelines
Time frame: 1 month after the completion of radiation therapy.
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.
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.
Plan to share: No
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