Neoadjuvant Modified FOLFIRINOX and Stereotactic Body Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/23/2019 |
| Start Date: | June 26, 2017 |
| End Date: | August 2022 |
Phase II Study to Evaluate Neoadjuvant Modified FOLFIRINOX and Stereotactic Body Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma
Surgical resection is the only potentially curative treatment for patients with pancreatic
cancer. Patients with BRPC have tumors in close contact with the vasculature but not to the
extent that resection is prohibited. Nonetheless, retrospective studies have shown that
immediate resection in these patients is associated with an increased risk of positive
margins, and a margin positive resection does not improve survival over that of patients with
unresectable disease. Moreover, even in those patients where a successful resection is
achieved, there is a high rate of early metastatic progression suggesting that
micrometastatic disease is often present at diagnosis. Therefore neoadjuvant therapy is
likely to improve outcomes in patients with BRPC to increase the likelihood of achieving a
margin negative resection, provide early control of occult micrometastatic disease, and
select those patients without systemic progression who would benefit from surgical resection.
cancer. Patients with BRPC have tumors in close contact with the vasculature but not to the
extent that resection is prohibited. Nonetheless, retrospective studies have shown that
immediate resection in these patients is associated with an increased risk of positive
margins, and a margin positive resection does not improve survival over that of patients with
unresectable disease. Moreover, even in those patients where a successful resection is
achieved, there is a high rate of early metastatic progression suggesting that
micrometastatic disease is often present at diagnosis. Therefore neoadjuvant therapy is
likely to improve outcomes in patients with BRPC to increase the likelihood of achieving a
margin negative resection, provide early control of occult micrometastatic disease, and
select those patients without systemic progression who would benefit from surgical resection.
Given the superior outcomes with FOLFIRINOX and the potential for improved local response
with SBRT, the investigators propose to evaluate the efficacy of pre-operative modified
FOLFIRINOX followed by SBRT in patients with borderline resectable pancreatic adenocarcinoma.
The investigators hypothesize that pre-operative modified FOLFIRINOX followed by SBRT will
improve the rate of R0 resections compared to historical controls treated with standard
gemcitabine-based chemotherapy and fractionated radiation prior to surgery.
with SBRT, the investigators propose to evaluate the efficacy of pre-operative modified
FOLFIRINOX followed by SBRT in patients with borderline resectable pancreatic adenocarcinoma.
The investigators hypothesize that pre-operative modified FOLFIRINOX followed by SBRT will
improve the rate of R0 resections compared to historical controls treated with standard
gemcitabine-based chemotherapy and fractionated radiation prior to surgery.
Inclusion Criteria:
- Histologically confirmed pancreatic adenocarcinoma
- Borderline resectable pancreatic adenocarcinoma, determined centrally by review of a
diagnostic CT scan and/or MRI scan with contrast by a dedicated surgical oncologist
and radiologist, or as determined by EUS, and defined according to the NCCN consensus
guidelines
- ECOG Performance Status of 0-1
- Age > 18
- Laboratory parameters as follows:
- Absolute neutrophil count >=1,500/uL
- Platelet count >=100,000/uL
- Hemoglobin >=9 g/dL
- Creatinine <1.5 X ULN or estimated GFR >30 ml/min
- Bilirubin =<1.5 X ULN
- AST and ALT =<3 X ULN
- Negative pregnancy test in women of childbearing potential
- Able to have fiducials placed in the pancreas
- Patients who received chemotherapy >5 years ago for malignancies other than pancreatic
cancer are eligible
Exclusion Criteria:
- Evidence of extrapancreatic disease on diagnostic imaging (CT, MRI, or PET scan), or
laparoscopy, including nodal involvement beyond the peripancreatic tissues and/or
distant metastases
- Evidence of invasion into the duodenum or stomach, as determined by EGD/EUS
- Prior treatment (chemotherapy, biological therapy, or radiotherapy) for pancreatic
cancer
- Prior treatment with oxaliplatin, irinotecan, fluoruouracil or capecitabine
- Major surgery within 4 weeks of study entry
- Other concurrent anticancer therapies
- Other malignancy within the past five years (exceptions include basal cell carcinoma
of the skin, cervical carcinoma in situ, and non-metastatic prostate cancer)
- Evidence of second malignancy at the time of study entry
- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- Grade 2 or greater sensory peripheral neuropathy
- Uncontrolled seizure disorder, active neurological disease, or known CNS disease
- Significant cardiac disease, including the following: unstable angina, New York Heart
Association class II-IV congestive heart failure, myocardial infarction within six
months prior to study enrollment
- Pregnant or nursing
- Other medical condition or reason that, in the opinion of the investigator, would
preclude study participation
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