Pancreas CancerEarly Phase 1NCT02707315
A Study of Pre-Operative Cyberknife in Patients With Potentially Resectable Pancreas Cancer
A Early Phase 1 study testing Gemcitabine and Stereotactic Radiosurgery in people with Pancreas Cancer and Pancreatic Cancer, run by Cooper Norcross Health at 1 site in United States.
Trial summary
This study is evaluating stereotactic radiosurgery (CyberKnife) plus chemotherapy for the treatment of potentially resectable adenocarcinoma of the pancreas Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Pancreatic Cancer, Adenocarcinoma of the Pancreas
- What is being tested?
- Gemcitabine and Stereotactic Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Pathologically confirmed adenocarcinoma of the pancreas
- Resectable or potentially resectable disease based on the following imaging criteria performed < 4 weeks from study entry and as determined by local review (Cooper radiologist)
- No extrapancreatic extension to nearby organs (ie; small bowel)
- No SMV/PV >180 degree involvement and/or reconstructable (as determined by Surgeon) occlusion
- No SMA Abutment TVI<180 degrees
- No Celiac trunk abutment Total volume involved < 180 degrees
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- Note that both resectable and potentially resectable patients are eligible
- ECOG ≤ 2
- Adequate hematologic and end organ function as defined by
- Hepatic transaminase levels < 3 x normal
- Total bilirubin < 5 mg/dl (if stented)
- Serum creatinine level < 1.6 mg/dl
- Absolute neutrophil count > 1,500cells/mm3
- Platelet count > 100,000 cells/mm3
- Medical status suitable for consideration of major pancreatic surgery
- Age >18 years
- Women of childbearing age and male participants must practice adequate contraception (hormonal or barrier method of birth control; abstinence) prior to and throughout study treatment.
- Life expectancy > 3 months
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Prior invasive malignancy within 5 years other than pancreatic adenocarcinoma
- Prior radiotherapy to the upper abdomen
- Severe comorbidity rendering a candidate ineligible for surgical resection
- Local, regional or distant extrapancreatic disease
- Patients of childbearing age who are unwilling or unable to practice contraception
- Failure to meet any of the above eligibility criteria
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- Inability to undergo MRI with contrast for treatment planning
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients may not be receiving any other investigational nor commercial agents with therapeutic intent to treat pancreatic cancer while on this trial.
- unresectable pancreatic cancer based on the following imaging criteria performed < 4 weeks from study entry and as determined by local review (Cooper radiologist)
- Extrapancreatic extension to nearby organs (ie; small bowel)
- SMV/PV >180 degree involvement and/or reconstructable (as determined by Surgeon) occlusion
- SMA Abutment TVI<180 degrees
- Celiac trunk abutment Total volume involved < 180 degrees
- Distant metastases
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103
Kim Krieger, 856-735-6237
About this study
This study is evaluating stereotactic radiosurgery (CyberKnife) plus chemotherapy for the treatment of potentially resectable adenocarcinoma of the pancreas
Read the detailed description
This study is evaluating the role of neoadjuvant chemotherapy and CyberKnife therapy in increasing the number of patients who are able to successfully undergo definitive surgical management of their pancreatic carcinoma. In addition, we will evaluate the associated therapeutic toxicities and gather data regarding the quality of life indicators at similar time intervals for an improved overall assessment of the effects of this course of treatment on our patients.
Surgery is deemed the only curative technique for pancreatic cancer. Unfortunately, more than 80% of patients who present with the disease cannot be cured by resection.
The literature reports median survival for resectable patients on the order of 19 months, with a 20% 5 year survival rate. For patients unable to undergo surgical resection, the median survival in the literature is approximately 11 months. In the absence of the proposed protocol, this patient population would be treated as per the standard of care for locally advanced non-metastatic surgically unresectable pancreatic malignancies, which would include a combination of chemotherapy and radiation therapy. The anticipated Grade 4 and above toxicity would be approximately 3-5% from this regimen. The rate of G 4 and above toxicity is not known with the use of this neoadjuvant regimen, and, therefore, this constitutes the major risk associated with this protocol therapy. The associated benefit, however, is the anticipated improvement in median survival that these patients may derive from the ability to successfully undergo surgical resection. A secondary proposed benefit is the potential for reduction in the treatment associated toxicity with this altered multimodality schedule when compared to traditional multimodality care or non-surgical care of locally advanced pancreatic malignancy.
- Conditions
- Pancreas Cancer, Pancreatic Cancer, Adenocarcinoma of the Pancreas, Pancreas Adenocarcinoma, Pancreatic Adenocarcinoma
- Being tested
- Gemcitabine, Stereotactic Radiosurgery
- Keywords
- Cyber Knife, CyberKnife, Stereotactic Radiosurgery, CK
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
Stereotactic RadiosurgeryRadiation
Also called CyberKnife, Cyber Knife, CK
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Chemotherapy:
Gemcitabine 1000 mg/m2 weekly x 3 on 28 day cycle
Radiation:
25 Gy over 5 fractions
Surgery:
surgical resection of pancreas
treatment plan:
1 cycle of chemotherapy, followed by stereotactic radiosurgery, followed by an additional 6 cycles of chemotherapy or surgical resection Receives: Drug: Gemcitabine; Radiation: Stereotactic Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of subjects who successfully undergo pancreaticoduodenectomy
Evaluate the percentage of subjects who successfully undergo pancreaticoduodenectomy
Measured: 2 months
Secondary outcomes (4)
Overall Survival
Measured: 6 months, 1 year, 5 years
Tumor response per RECIST 1.1
Measured: 2-8 months
Quality of Life
Measured: 2-8 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707315
- Sponsor's protocol ID
- 12-169
- Status last verified
- Oct 2015
- First submitted
- 2 Oct 2015
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Pre-Operative Cyberknife in Patients With Potentially Resectable Pancreas Cancer
- ClinicalTrials.gov ID
- NCT02707315
- Acronym / sponsor ID
- 12-169
- Conditions
- Pancreas Cancer, Pancreatic Cancer, Adenocarcinoma of the Pancreas, Pancreas Adenocarcinoma, Pancreatic Adenocarcinoma
- Keywords
- Cyber Knife, CyberKnife, Stereotactic Radiosurgery, CK
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2016 (estimated)
- First posted
- 14 Mar 2016 (estimated)
- 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.
This study is evaluating stereotactic radiosurgery (CyberKnife) plus chemotherapy for the treatment of potentially resectable adenocarcinoma of the pancreas
Detailed description
This study is evaluating the role of neoadjuvant chemotherapy and CyberKnife therapy in increasing the number of patients who are able to successfully undergo definitive surgical management of their pancreatic carcinoma. In addition, we will evaluate the associated therapeutic toxicities and gather data regarding the quality of life indicators at similar time intervals for an improved overall assessment of the effects of this course of treatment on our patients.
Surgery is deemed the only curative technique for pancreatic cancer. Unfortunately, more than 80% of patients who present with the disease cannot be cured by resection.
The literature reports median survival for resectable patients on the order of 19 months, with a 20% 5 year survival rate. For patients unable to undergo surgical resection, the median survival in the literature is approximately 11 months. In the absence of the proposed protocol, this patient population would be treated as per the standard of care for locally advanced non-metastatic surgically unresectable pancreatic malignancies, which would include a combination of chemotherapy and radiation therapy. The anticipated Grade 4 and above toxicity would be approximately 3-5% from this regimen. The rate of G 4 and above toxicity is not known with the use of this neoadjuvant regimen, and, therefore, this constitutes the major risk associated with this protocol therapy. The associated benefit, however, is the anticipated improvement in median survival that these patients may derive from the ability to successfully undergo surgical resection. A secondary proposed benefit is the potential for reduction in the treatment associated toxicity with this altered multimodality schedule when compared to traditional multimodality care or non-surgical care of locally advanced pancreatic malignancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Gemcitabine, Radiation: Stereotactic RadiosurgeryChemotherapy: Gemcitabine 1000 mg/m2 weekly x 3 on 28 day cycle Radiation: 25 Gy over 5 fractions Surgery: surgical resection of pancreas treatment plan: 1 cycle of chemotherapy, followed by stereotactic radiosurgery, followed by an additional 6 cycles of chemotherapy or surgical resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Pathologically confirmed adenocarcinoma of the pancreas
- Resectable or potentially resectable disease based on the following imaging criteria performed < 4 weeks from study entry and as determined by local review (Cooper radiologist)
- ECOG ≤ 2
- Adequate hematologic and end organ function as defined by
- Medical status suitable for consideration of major pancreatic surgery
Key exclusion criteria (15 listed)
- Prior invasive malignancy within 5 years other than pancreatic adenocarcinoma
- Prior radiotherapy to the upper abdomen
- Severe comorbidity rendering a candidate ineligible for surgical resection
- Local, regional or distant extrapancreatic disease
- Patients of childbearing age who are unwilling or unable to practice contraception
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 |
|---|---|---|
| GemcitabineAlso: Gemzar | Drug | A |
| Stereotactic RadiosurgeryAlso: CyberKnife, Cyber Knife, CK | Radiation | A |
Primary outcome
percentage of subjects who successfully undergo pancreaticoduodenectomy
Time frame: 2 months
Evaluate the percentage of subjects who successfully undergo pancreaticoduodenectomy
4 secondary outcomes
Overall Survival
Time frame: 6 months, 1 year, 5 years
Tumor response per RECIST 1.1
Time frame: 2-8 months
Quality of Life
Time frame: 2-8 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gemcitabine and Stereotactic Radiosurgery in people with Pancreas Cancer and Pancreatic Cancer, run by Cooper Norcross Health 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 19 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 14 Mar 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Krieger (856-735-6237, krieger-kimberly@cooperhealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of subjects who successfully undergo pancreaticoduodenectomy (time frame: 2 months). 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 14 Mar 2016.