Status:
ACTIVE_NOT_RECRUITING
A Phase I Dual Dose Escalation Study of Radiation and Nab-Paclitaxel in Patients With Unresectable and Borderline Resectable Pancreatic Cancer
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Locally Advanced Unresectable Pancreatic Cancer Treated With Chemoradiotherapy
Borderline Resectable Pancreatic Cancer Treated With Chemoradiotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The investigators hypothesize that intensification of local therapy will lead to improvements in local control and survival in patients with unresectable and borderline resectable pancreatic cancer. W...
Eligibility Criteria
Inclusion
- Pathologically confirmed adenocarcinoma of the pancreas.
- Unresectable disease or borderline resectable disease assessed by a multidisciplinary panel of pancreas surgeon, medical and radiation oncologist, and a radiologist. Criteria defining unresectable and borderline resectable patients will be based on the NCCN Guidelines (v 1.2014):
- Unresectable
- Greater than 180 degrees of SMA encasement
- Any celiac abutment
- Unreconstructible SMV/portal occlusion
- Aortic invasion or encasement
- Nodal metastases beyond the field of resection Borderline resectable
- Venous involvement of the SMV/portal vein demonstrating tumor abutment with impingement and narrowing of the lumen
- Encasement of the SMV/portal vein but without encasement of the nearby arteries
- Short-segment venous occlusion resulting from either tumor thrombus or encasement with suitable proximal and distal vessel for reconstruction/grafting.
- Gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to celiac axis
- Tumor abutment to SMA but not to exceed greater than 180 degrees of circumferential vessel wall
- Age \> 18 years.
- ECOG performance status of ≤ 1.
- Adequate organ function defined as follows: absolute neutrophil count of ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum creatinine ≤ 2 mg/dl, total bilirubin ≤ 3, (with relief of biliary obstruction if present (PTC tube or endobiliary stent) and AST \< 5 times the upper limit of normal.
- Patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after the trial.
- Patients must be able to provide written informed consent.
Exclusion
- Distant metastatic disease.
- Prior history of abdominal radiation therapy.
- Prior systemic therapy for pancreatic cancer.
- Prior or simultaneous malignancy within the past 2 years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ, thyroid carcinoma, or low-risk prostate cancer). In-situ carcinoma is allowed.
- Serious uncontrolled concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
- Treatment with an investigational anti-cancer agent within 4 weeks prior to enrollment into the study.
- Pregnant women, women planning to become pregnant and women that are nursing
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02207465
Start Date
July 1 2014
End Date
December 1 2026
Last Update
November 19 2025
Active Locations (2)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
2
Chester County Hospital
West Chester, Pennsylvania, United States, 19380