A Dose Escalation Trial of SBRT After Induction Chemotherapy for Locally Advanced Pancreatic Cancer
NCT ID: NCT02873598
Last Updated: 2022-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2016-11-17
2022-11-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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FOLFIRINOX or gemcitabine/abraxane followed by SBRT Dose level 1
SBRT will be administered in 3 fractions, every other day, on an outpatient basis, following chemotherapy with either FOLFIRINOX or gemcitabine/abraxane. Dose level 1- 9 Gy x 3 fractions.
FOLFIRINOX or gemcitabine/abraxane
Patients will have received induction chemotherapy for 3+ months with either FOLFIRINOX or gemcitabine/abraxane with at least stable disease.
SBRT
After completion of induction chemotherapy, stereotactic body radiation therapy (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.
FOLFIRINOX or gemcitabine/abraxane followed by SBRT Dose level 2
SBRT will be administered in 3 fractions, every other day, on an outpatient basis, following chemotherapy with either FOLFIRINOX or gemcitabine/abraxane. Dose level 2 -10 Gy x 3 fractions
FOLFIRINOX or gemcitabine/abraxane
Patients will have received induction chemotherapy for 3+ months with either FOLFIRINOX or gemcitabine/abraxane with at least stable disease.
SBRT
After completion of induction chemotherapy, stereotactic body radiation therapy (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.
FOLFIRINOX or gemcitabine/abraxane followed by SBRT Dose level 3
SBRT will be administered in 3 fractions, every other day, on an outpatient basis, following chemotherapy with either FOLFIRINOX or gemcitabine/abraxane. Dose level 3 - 11 Gy x 3 fractions.
FOLFIRINOX or gemcitabine/abraxane
Patients will have received induction chemotherapy for 3+ months with either FOLFIRINOX or gemcitabine/abraxane with at least stable disease.
SBRT
After completion of induction chemotherapy, stereotactic body radiation therapy (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.
Interventions
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FOLFIRINOX or gemcitabine/abraxane
Patients will have received induction chemotherapy for 3+ months with either FOLFIRINOX or gemcitabine/abraxane with at least stable disease.
SBRT
After completion of induction chemotherapy, stereotactic body radiation therapy (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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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 portal vein (PV) involvement.
3. No evidence of distant metastasis either prior to or after induction chemotherapy.
4. 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.
5. Pancreatic tumor size ≤ 5 cm.
6. Age ≥18 years.
7. ECOG 0-1.
8. Patients must have acceptable organ and marrow function as defined below:
* Leukocytes \>3,000/µL
* Absolute neutrophil count \>1,500/µL
* Platelets \>70,000/µL
* Total bilirubin Within 2 x upper limit of normal
* AST (SGOT)/ALT (SGPT) \<2.5 x institutional upper limit of normal
* Creatinine Within 1.5 x upper limit of normal OR
* Creatinine clearance \>60 mL/min for patients with creatinine levels above institutional normal
9. 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.
10. Ability to understand and the willingness to sign a written informed consent document.
11. Residual or on-going ≥ Grade 3 treatment-related toxicity from previous chemotherapy
Exclusion Criteria
2. Patients receiving any investigational agents.
3. 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.
4. Contraindication to IV contrast
5. Patients in which iodine contrast is contraindicated.
6. 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.
18 Years
99 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Sana Karam, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado
Aurora, Colorado, United States
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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16-1139.cc
Identifier Type: -
Identifier Source: org_study_id