Pancreatic TumorNCT01434550
Phase II Study of First-line SBRT in Patients With Non-Metastatic Unresectable Pancreatic Cancer
A study testing Stereotactic Body Radiation Therapy (SBRT) and Tissue, Blood, Research Imaging (TBRI) in people with Pancreatic Tumor, run by H. Lee Moffitt Cancer Center and Research Institute.
Trial summary
The purpose of this study is to see if SBRT will be a better way to treat pancreas cancer and to find out what effects, good and/or bad, this treatment will have on participants and their cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Tumor
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT) and Tissue, Blood, Research Imaging (TBRI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Aug 2015
- Phase
- Interventional
- 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
- Biopsy proven, non-metastatic, pancreatic cancer
- Unresectable disease based on institutional standardized criteria for unresectability
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- CT scan of chest and abdomen (3-phase pancreas protocol), and PET-CT within 4 weeks of study entry
- Patients with biliary or gastroduodenal obstruction must have drainage, duodenal stenting, or gastric bypass prior to initiating radiation
- All disease must be encompassed in a single radiation field
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- No evidence or history of an autoimmune dysfunction
- Negative pregnancy test within 7 days of study entry
- No prior or concurrent chemotherapy
- No previous or concurrent immunotherapy for pancreatic cancer
- Liver enzymes ≤ 3 times upper limit of normal (ULN): total bilirubin (Tbili) ≤ 3.9 (biliary stents are allowed); aspartic transaminase (AST) ≤ 177; alanine transaminase (ALT) ≤ 198; Alkaline phosphatase (ALK-P) ≤ 378
- Adequate pretreatment organ function: Creatinine no greater than 1.5mg/dL; Total calcium no greater than 11.0mg/dL; prothrombin time (PT) no greater then 14 seconds; partial thromboplastin time (PTT) no greater then 40 seconds
- Ability to give informed consent
- Adequate baseline hematopoietic function: total white blood cell count equal to or greater than 3,000/mm³; absolute granulocyte count greater than 1,500/mm³; absolute lymphocyte count greater than 500/mm³; platelet count equal to or greater than 100,000/mm³
- All Participant inclusion criteria
- Amenable to leukapheresis as determined by a leukapheresis nurse
- Primary tumor that is accessible to direct intratumoral injection by CT-guidance confirmed by interventional radiologist
- No history of autoimmune disease
- No history of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) or other immunosuppressive diseases
- No active viral or bacterial infection
- No use of steroids or any other immunosuppressive drug at least 4 weeks prior to enrollment on study
Who cannot join
- Prior history of radiotherapy that overlaps with the planned ports to the primary pancreatic tumor
- Patients with tumors that are not accessible to direct access cannot be included in the study.
- Prior or concurrent chemotherapy
- Prior history of antineoplastic therapy or irradiation
- Prior treatment with anti-tumor vaccines not allowed
- Patients with a history of autoimmune diseases
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- A history of HIV infection, AIDS or other immunosuppressive disease state. The need to exclude patients with HIV/AIDS is because one of the endpoints of the study is immune response. People with HIV have a compromised immune system and enrollment in this study could confound the results (TBRI only)
- Patients requiring corticosteroids are ineligible because one of the endpoints of the study is immune response. Since steroids modulate the immune system, enrollment of patients on steroids could confound the results. There must be no use of corticosteroids in the fours weeks preceding entry into the study (TBRI only).
- Active bacterial, fungal or viral infection
- Active bleeding (hemoptysis, melena, etc.)
- Women who are currently pregnant or actively breast feeding. Women of childbearing potential must have a negative serum pregnancy test and must use effective contraception during trial participation
- Any medical or psychiatric illness which in the opinion of the principal investigator might compromise a patient's ability to tolerate or complete treatment
- Any patient requiring blood thinners (due to risk of gastrointestinal [GI] bleed)
About this study
Official title: Phase II Study of First-line Stereotactic Body Radiation Therapy (SBRT) in Patients With Non-Metastatic Unresectable Pancreatic Cancer
The purpose of this study is to see if SBRT will be a better way to treat pancreas cancer and to find out what effects, good and/or bad, this treatment will have on participants and their cancer.
Read the detailed description
The standard treatment for cancer of the pancreas is surgery (if possible), external beam radiation therapy and/or chemotherapy. These standard treatments are not a cure and often extend life by just a few months. Recently, a new approach has been developed, called stereotactic body radiation therapy (SBRT). Based on the results of earlier studies using SBRT, the study doctors at Moffitt feel this is a reasonable alternative to the standard treatment for your disease.
Stereotactic body radiation therapy (SBRT) delivers high radiation doses to the tumor every day for 5 days which gives the usual 5-6 week course of radiation in less than a week. It has also been shown to have much less side effects.
The purpose of this study is to see if SBRT will be a better way to treat pancreas cancer and to find out what effects, good and/or bad, this treatment will have on you and your cancer.
Six patients will be asked to be part of a subgroup called TBRI (Tissue, Blood, Research Imaging). In this subgroup, the investigators want to study if there is early death of tumor cells from the treatment by looking at the tumor using PET/CT scans and biopsies, and by testing your body's white blood cells taken by a procedure called leukapheresis. You do not have to take part in the TBRI subgroup to get treatment on this study with SBRT.
- Conditions
- Pancreatic Tumor
- Being tested
- Stereotactic Body Radiation Therapy (SBRT), Tissue, Blood, Research Imaging (TBRI)
- Keywords
- pancreas, pancreatic cancer, SBRT, stereotactic body radiation, radiation therapy, unresectable, non-metastatic, tissue, blood, research imaging, TBRI
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Also called extracranial lesions, high-dose fractions, radiosurgery
Everyone who takes part in this study will receive SBRT. After making an individual radiation plan for each participant, they will receive 5 days of radiation to the pancreas. Participants will have follow-up visits with blood tests one month after the end of SBRT and then every 3 months for 3 years. They will also have CT scans (chest and pancreas) and FDG PET/CT (body) at 1 month and then at 3, 6, 9 and 12 months.
Tissue, Blood, Research Imaging (TBRI)Radiation
Also called CT guided biopsy, Imaging to evaluate cell death, Aposense-PET imaging
Post-SBRT procedures (day 1, 3, 5 of SBRT, and 4 weeks after) A) Endoscopic or CT guided biopsy of treated pancreatic cancer to assess
- Necrosis/apoptosis
- Lymphocyte infiltrate and antigen presenting cells B) Imaging to evaluate cell death (day 1, 3, 5 of SBRT, and 4 weeks after)
- Aposense-PET imaging
| Study group | Role | What they receive |
|---|---|---|
| TBRI Subgroup: TBRI and SBRT | Active comparator | Six patients will be asked to be part of a subgroup called TBRI (Tissue, Blood, Research Imaging). In this subgroup, we want to study if there is early death of tumor cells from the treatment by looking at the tumor using PET/CT scans and biopsies, and by testing the participant's body's white blood cells taken by a procedure called leukapheresis.
Participants do not have to take part in the TBRI subgroup to get treatment on this study with SBRT.
SBRT:
1. 30 Gy in 5 fractions to pancreatic tumor
2. 50 Gy in 5 daily consecutive fractions unresectable portion and avoiding bowel, stomach, and duodenum Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT); Radiation: Tissue, Blood, Research Imaging (TBRI) |
| SBRT Alone | Active comparator | 1. 30 Gy in 5 fractions to pancreatic tumor
2. 50 Gy in 5 daily consecutive fractions unresectable portion and avoiding bowel, stomach, and duodenum Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Overall Survival (OS)
Patients will be followed for 36 months to determine overall survival even after completion of the experimental portion of the protocol. Patients will be followed every 3 months. All patients will be referred for chemotherapy at the completion of radiation.
Measured: 36 Months
Secondary outcomes (2)
Number of Participants With Reduction in Size of Primary Tumor
Patients will undergo 64 slice helical computed tomography (CT) scan and feeding (FDG) pressure equalizing tube (PET)-CT scan pretreatment and at the conclusion of the study which will be separated by a 5 week time span. Subsequent helical CT and FDG PET-CT scans will be performed at 3, 6, 9 and 12 months with CA 19-9 levels. The Response Evaluation Criteria In Solid Tumors (RECIST) criteria will be used to measure clinical response. Time to local and distant disease progression will also be measured.
Measured: 12 Months
Number of Participants With Adverse Events (AEs)
Toxicity response will be assessed and reported using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startMar 2012
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Why it stopped: research cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic TumorStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ravi Shridhar, M.D., Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434550
- Sponsor's protocol ID
- MCC-16459
- Status last verified
- Feb 2017
- First submitted
- 13 Sep 2011
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of First-line Stereotactic Body Radiation Therapy (SBRT) in Patients With Non-Metastatic Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01434550
- Acronym / sponsor ID
- MCC-16459
- Conditions
- Pancreatic Tumor
- Keywords
- pancreas, pancreatic cancer, SBRT, stereotactic body radiation, radiation therapy, unresectable, non-metastatic, tissue, blood, research imaging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: research cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 15 Sep 2011 (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.
The purpose of this study is to see if SBRT will be a better way to treat pancreas cancer and to find out what effects, good and/or bad, this treatment will have on participants and their cancer.
Detailed description
The standard treatment for cancer of the pancreas is surgery (if possible), external beam radiation therapy and/or chemotherapy. These standard treatments are not a cure and often extend life by just a few months. Recently, a new approach has been developed, called stereotactic body radiation therapy (SBRT). Based on the results of earlier studies using SBRT, the study doctors at Moffitt feel this is a reasonable alternative to the standard treatment for your disease.
Stereotactic body radiation therapy (SBRT) delivers high radiation doses to the tumor every day for 5 days which gives the usual 5-6 week course of radiation in less than a week. It has also been shown to have much less side effects.
The purpose of this study is to see if SBRT will be a better way to treat pancreas cancer and to find out what effects, good and/or bad, this treatment will have on you and your cancer.
Six patients will be asked to be part of a subgroup called TBRI (Tissue, Blood, Research Imaging). In this subgroup, the investigators want to study if there is early death of tumor cells from the treatment by looking at the tumor using PET/CT scans and biopsies, and by testing your body's white blood cells taken by a procedure called leukapheresis. You do not have to take part in the TBRI subgroup to get treatment on this study with SBRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBRI Subgroup: TBRI and SBRT | Active comparator | Radiation: Stereotactic Body Radiation Therapy (SBRT), Radiation: Tissue, Blood, Research Imaging (TBRI)Six patients will be asked to be part of a subgroup called TBRI (Tissue, Blood, Research Imaging). In this subgroup, we want to study if there is early death of tumor cells from the treatment by looking at the tumor using PET/CT scans and biopsies, and by testing the participant's body's white blood cells taken by a procedure called leukapheresis. Participants do not have to take part in the TBRI subgroup to get treatment on this study with SBRT. SBRT: 1. 30 Gy in 5 fractions to pancreatic tumor 2. 50 Gy in 5 daily consecutive fractions unresectable portion and avoiding bowel, stomach, and duodenum |
| SBRT Alone | Active comparator | Radiation: Stereotactic Body Radiation Therapy (SBRT)1. 30 Gy in 5 fractions to pancreatic tumor 2. 50 Gy in 5 daily consecutive fractions unresectable portion and avoiding bowel, stomach, and duodenum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Biopsy proven, non-metastatic, pancreatic cancer
- Unresectable disease based on institutional standardized criteria for unresectability
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- CT scan of chest and abdomen (3-phase pancreas protocol), and PET-CT within 4 weeks of study entry
- Patients with biliary or gastroduodenal obstruction must have drainage, duodenal stenting, or gastric bypass prior to initiating radiation
Key exclusion criteria (13 listed)
- Prior history of radiotherapy that overlaps with the planned ports to the primary pancreatic tumor
- Patients with tumors that are not accessible to direct access cannot be included in the study.
- Prior or concurrent chemotherapy
- Prior history of antineoplastic therapy or irradiation
- Prior treatment with anti-tumor vaccines not allowed
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 |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)Also: extracranial lesions, high-dose fractions, radiosurgeryEveryone who takes part in this study will receive SBRT. After making an individual radiation plan for each participant, they will receive 5 days of radiation to the pancreas. Participants will have follow-up visits with blood tests one month after the end of SBRT and then every 3 months for 3 years. They will also have CT scans (chest and pancreas) and FDG PET/CT (body) at 1 month and then at 3, 6, 9 and 12 months. | Radiation | SBRT Alone, TBRI Subgroup: TBRI and SBRT |
| Tissue, Blood, Research Imaging (TBRI)Also: CT guided biopsy, Imaging to evaluate cell death, Aposense-PET imagingPost-SBRT procedures (day 1, 3, 5 of SBRT, and 4 weeks after) A) Endoscopic or CT guided biopsy of treated pancreatic cancer to assess 1. Necrosis/apoptosis 2. Lymphocyte infiltrate and antigen presenting cells B) Imaging to evaluate cell death (day 1, 3, 5 of SBRT, and 4 weeks after) 1. Aposense-PET imaging | Radiation | TBRI Subgroup: TBRI and SBRT |
Primary outcome
Number of Participants With Overall Survival (OS)
Time frame: 36 Months
Patients will be followed for 36 months to determine overall survival even after completion of the experimental portion of the protocol. Patients will be followed every 3 months. All patients will be referred for chemotherapy at the completion of radiation.
2 secondary outcomes
Number of Participants With Reduction in Size of Primary Tumor
Time frame: 12 Months
Number of Participants With Adverse Events (AEs)
Time frame: 36 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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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.
Ravi Shridhar, M.D., Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy (SBRT) and Tissue, Blood, Research Imaging (TBRI) in people with Pancreatic Tumor, run by H. Lee Moffitt Cancer Center and Research Institute.
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 21 inclusion and 13 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: withdrawn, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Overall Survival (OS) (time frame: 36 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 23 Feb 2017.