Pancreatic CancerPhase 1NCT02643498
A Dose Escalation Trial of Stereotactic Body Radiotherapy (SBRT) After Induction Chemotherapy for Locally Advanced Pancreatic Cancer
A Phase 1 study testing Stereotactic Body Radiotherapy (SBRT) in people with Pancreatic Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to find out the maximum dose of SBRT that can be safely given after chemotherapy for treatment of pancreatic cancer that cannot be removed surgically. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Stereotactic Body Radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2015to 16 Dec 2024
- Phase
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically or cytopathologically confirmed adenocarcinoma of the pancreas.
- Locally advanced, unresectable pancreatic cancer as confirmed by the multidisciplinary input from a hepatobiliary surgeon and as defined on CT as having tumor abutment of >180° (> 50%) of the circumference of the superior mesenteric artery (SMA) or celiac axis, unreconstructable superior mesenteric vein (SMV) or PV involvement.
- No evidence of distant metastasis either prior to or after induction chemotherapy.
- Completion of at least 3 months, but no more than 6 months of standard induction chemotherapy for LAPC, which may include FOLFIRINOX or gemcitabine and nab-paclitaxel, preferably within 2-4 weeks but no longer than 8 weeks.
- Pancreatic tumor size ≤ 5 cm.
- Age ≥18 years
Show all 16Show fewer
- ECOG 0-1.
- Patients must have acceptable organ and marrow function as defined below:
- Leukocytes >3,000/uL
- Absolute neutrophil count >1,500/uL
- Platelets >50,000/uL
- Total bilirubin Within 2 x upper limit of normal
- AST (SGOT)/ALT (SGPT) <2.5 x institutional upper limit of normal
- Creatinine-Creatinine clearance Within 1.5 x upper limit of normal OR >60 mL/min for patients with creatinine levels above institutional normal
- Ability to understand and follow the breathing instructions involved in the respiratory gating procedure or to tolerate compression sufficient to reduce fiducial motion to ≤ 5mm
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who have had prior abdominal radiotherapy.
- Patients receiving any other investigational agents
- 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.
- Contraindication to Magnetic Resonance Imaging
- Patients in which iodine contrast is contraindicated
- Pregnant and breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study are excluded. This applies to any woman who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months, or women on hormone replacement therapy with serum FSH levels greater than 35 mIU/mL. A negative urine or serum pregnancy test must be obtained within 14 days prior to the start of study therapy in all women of child-bearing potential. Male subjects must also agree to use effective contraception for the same period as above.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (Consent and follow-up only)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Consent and follow-up only)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Consent and follow-up only)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent and follow-up only)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (Consent and Follow-up)
Rockville Centre, New York
About this study
The purpose of this study is to find out the maximum dose of SBRT that can be safely given after chemotherapy for treatment of pancreatic cancer that cannot be removed surgically.
- Conditions
- Pancreatic Cancer
- Being tested
- Stereotactic Body Radiotherapy (SBRT)
- Keywords
- Stereotactic Body Radiotherapy (SBRT), 15-109
- 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 Radiotherapy (SBRT)Radiation
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | Experimental | Cohorts 1-3 After completion of induction chemotherapy, stereotactic body radiotherapy (SBRT) will be administered in 3 fractions, every other day, on an outpatient basis. Dose escalation will start with dose level 1 (9 Gy x 3 fractions) and increase by 1 Gy per fraction at each dose level, dose level 2 will be 10 Gy x 3 fractions and dose level 3 will be 11 Gy x 3 fractions.
Cohorts 4-6 For cohort 4, dose prescription will start at 7 Gy x 6 fractions (42Gy, isoeffective to 11 Gy x 3), followed by 4.8 Gy x 12 (54Gy) and 4.5Gy x 15 (67.5Gy). Receives: Radiation: Stereotactic Body Radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated dose (MTD) of SBRT
Dose limiting toxicities (DLT) are defined by ≥ Grade 3 treatment-related GI toxicity within 3 months of SBRT. These include: (1) Bowel (includes bowel perforation, obstruction, or hemorrhage) and (2) Stomach (bleeding ulcer, perforation). We will employ a standard 3+3 dose-escalation scheme. Patients will be accrued to the study in cohorts of 3.
Measured: after at least 3 months of induction chemortherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marsha Reyngold, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643498
- Sponsor's protocol ID
- 15-109
- Status last verified
- Dec 2024
- First submitted
- 29 Dec 2015
- Last updated
- 20 Dec 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation Trial of Stereotactic Body Radiotherapy (SBRT) After Induction Chemotherapy for Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02643498
- Acronym / sponsor ID
- 15-109
- Conditions
- Pancreatic Cancer
- Keywords
- Stereotactic Body Radiotherapy (SBRT), 15-109
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 31 Dec 2015 (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 find out the maximum dose of SBRT that can be safely given after chemotherapy for treatment of pancreatic cancer that cannot be removed surgically.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | Experimental | Radiation: Stereotactic Body Radiotherapy (SBRT)Cohorts 1-3 After completion of induction chemotherapy, stereotactic body radiotherapy (SBRT) will be administered in 3 fractions, every other day, on an outpatient basis. Dose escalation will start with dose level 1 (9 Gy x 3 fractions) and increase by 1 Gy per fraction at each dose level, dose level 2 will be 10 Gy x 3 fractions and dose level 3 will be 11 Gy x 3 fractions. Cohorts 4-6 For cohort 4, dose prescription will start at 7 Gy x 6 fractions (42Gy, isoeffective to 11 Gy x 3), followed by 4.8 Gy x 12 (54Gy) and 4.5Gy x 15 (67.5Gy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically or cytopathologically confirmed adenocarcinoma of the pancreas.
- Locally advanced, unresectable pancreatic cancer as confirmed by the multidisciplinary input from a hepatobiliary surgeon and as defined on CT as having tumor abutment of >180° (> 50%) of the circumference of the superior mesenteric artery (SMA) or celiac axis, unreconstructable superior mesenteric vein (SMV) or PV involvement.
- No evidence of distant metastasis either prior to or after induction chemotherapy.
- Completion of at least 3 months, but no more than 6 months of standard induction chemotherapy for LAPC, which may include FOLFIRINOX or gemcitabine and nab-paclitaxel, preferably within 2-4 weeks but no longer than 8 weeks.
- Pancreatic tumor size ≤ 5 cm.
Key exclusion criteria (6 listed)
- Patients who have had prior abdominal radiotherapy.
- Patients receiving any other investigational agents
- 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.
- Contraindication to Magnetic Resonance Imaging
- Patients in which iodine contrast is contraindicated
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 Radiotherapy (SBRT) | Radiation | Stereotactic Body Radiotherapy (SBRT) |
Primary outcome
maximum tolerated dose (MTD) of SBRT
Time frame: after at least 3 months of induction chemortherapy
Dose limiting toxicities (DLT) are defined by ≥ Grade 3 treatment-related GI toxicity within 3 months of SBRT. These include: (1) Bowel (includes bowel perforation, obstruction, or hemorrhage) and (2) Stomach (bleeding ulcer, perforation). We will employ a standard 3+3 dose-escalation scheme. Patients will be accrued to the study in cohorts of 3.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Marsha Reyngold, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stereotactic Body Radiotherapy (SBRT) in people with Pancreatic Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites 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 16 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: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
maximum tolerated dose (MTD) of SBRT (time frame: after at least 3 months of induction chemortherapy). 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 20 Dec 2024.