Pancreas AdenocarcinomaNCT04998552
Safety of Cyberknife in Patients With Borderline Resectable or Locally Advanced Pancreatic Adenocarcinoma
A study testing Cyberknife in people with Pancreas Adenocarcinoma, run by Capital Health System, Inc at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Adenocarcinoma
- What is being tested?
- Cyberknife
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2021to 22 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patient has a diagnosis of Stage I to Stage III pancreatic cancer cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria and NCCN guidelines, based on radiographic imaging or exploratory laparoscopic surgery, low degree of arterial involvement (CA, CHA, SMA) and no aorta involvement.
- Patients who are deemed eligible for IMRT or SBRT and approved to receive radiation therapy by multidisciplinary tumor board
- Patient shows no evidence of disease progression to distant metastasis based on NCCN.
- Negative pregnancy test
Who cannot join
- 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.
- Patients with implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity.
- Life expectancy of < 1 year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Capital Health Medical Center-Hopewell
Pennington, New Jersey, 08534
Patrick DeDeyne, PhD, 609-394-4130, pdedeyne@capitalhealth.org
About this study
Official title: Safety and Efficacy of Cyberknife in Patients With Borderline Resectable or Locally Advanced Pancreatic Adenocarcinoma: Open Label Prospective Randomized Clinical 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.
Read the detailed description
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.
- Conditions
- Pancreas Adenocarcinoma
- Being tested
- Cyberknife
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyberknifeRadiation
5-10 Gy/fraction.Average of 45 minutes every other day for a total of 5 sessions (1.5-2 weeks).
| Study group | Role | What they receive |
|---|---|---|
| SBRT (Cyberknife) | Experimental | 5-10 Gy/fraction. Average of 45 minutes every other day for a total of 5 sessions (1.5-2 weeks). Receives: Radiation: Cyberknife |
| IMRT | Active comparator | 1.2-3 Gy/fraction up to 40 fractions. 15 mins daily (M-F) for a total of 28 sessions (5.5 weeks). Receives: Radiation: Cyberknife |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resectability
Occurrence of meeting resectability criteria using NCCN (PAN-C) guidelines
Measured: 1 month after the completion of radiation therapy.
Secondary outcomes (2)
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.
Measured: 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.
Measured: At baseline and then at 3 month intervals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start22 Jun 2021
- Primary completion22 Jun 2027 (estimated)
- Study completion22 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is an open-label, longitudinal, prospective randomized, superiority clinical trial.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Health System, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shirnett Williamson, MD, Principal investigator, Capital Health System, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998552
- Sponsor's protocol ID
- PANCAN SBRT
- Status last verified
- Mar 2023
- First submitted
- 20 Jul 2021
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Cyberknife in Patients With Borderline Resectable or Locally Advanced Pancreatic Adenocarcinoma: Open Label Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04998552
- Acronym / sponsor ID
- PANCAN SBRT
- Conditions
- Pancreas Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Capital Health System, IncUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 22 Jun 2027 (estimated)
- Study completion
- 22 Jun 2027 (estimated)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is an open-label, longitudinal, prospective randomized, superiority clinical trial.
| Arm | Type | Receives |
|---|---|---|
| SBRT (Cyberknife) | Experimental | Radiation: Cyberknife5-10 Gy/fraction. Average of 45 minutes every other day for a total of 5 sessions (1.5-2 weeks). |
| IMRT | Active comparator | Radiation: Cyberknife1.2-3 Gy/fraction up to 40 fractions. 15 mins daily (M-F) for a total of 28 sessions (5.5 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Patient has a diagnosis of Stage I to Stage III pancreatic cancer cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria and NCCN guidelines, based on radiographic imaging or exploratory laparoscopic surgery, low degree of arterial involvement (CA, CHA, SMA) and no aorta involvement.
Key exclusion criteria (6 listed)
- 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.
- Patients with implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyberknife5-10 Gy/fraction.Average of 45 minutes every other day for a total of 5 sessions (1.5-2 weeks). | Radiation | IMRT, SBRT (Cyberknife) |
Primary outcome
Resectability
Time frame: 1 month after the completion of radiation therapy.
Occurrence of meeting resectability criteria using NCCN (PAN-C) guidelines
2 secondary outcomes
Patient Reported Outcome (General) - European Organization for Research and Treatment of Cancer (EORTC).
Time frame: at baseline and then at 3 month intervals.
Patient Reported Outcome (Specific)European Organization for Research and Treatment of Cancer (EORTC).
Time frame: At baseline and then at 3 month intervals.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shirnett Williamson, MD principal investigator
Capital Health System, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyberknife in people with Pancreas Adenocarcinoma, run by Capital Health System, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shirnett Williamson, MD (609-303-4244, swilliamson@capitalhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resectability (time frame: 1 month after the completion of radiation therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.