Chemoradiation and Radiosurgery Boost in Treating Patients With Locally Advance Pancreatic Cancer That May or May Not be Removed by Surgery

Stopped early · Phase 1

Conditions studied: Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Stage IIB Pancreatic Cancer, Stage III Pancreatic Cancer

In brief

This phase I trial studies the side effects and best dose of radiosurgery boost following chemoradiation in treating patients with locally advanced pancreatic cancer that may or may not be removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving chemotherapy and radiation therapy together with radiosurgery may kill more tumor cells and allow doctors to save the part of the body where the cancer started

Key facts

Study ID: NCT01739439
Run by: Fox Chase Cancer Center
People needed: 6
Starts: 2013-05-01
Expected to finish: 2015-12-01
Last updated by the study team: 2019-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically or cytologically-confirmed pancreatic adenocarcinoma
For the initial dose escalation study, patients must have locally advanced / unresectable pancreatic cancer; these are defined as follows:
No distant metastases
Hepatic artery encasement
Superior mesenteric artery (SMA) encasement > 180 degrees
Any celiac axis abutment
Unreconstructable superior mesenteric vein (SMV)/portal occlusion
Aortic invasion or encasement
Metastases to lymph nodes beyond the field of resection
For the expansion phase, patients must have borderline resectable or locally advanced / unresectable pancreatic cancer; these are defined as follows:
No distant metastases
At least 45 degree abutment of the hepatic artery or SMA
Any celiac axis abutment
Near complete occlusion of the SMV or portal vein
Unreconstructable or reconstructible SMV/portal occlusion
Aortic invasion or encasement
Metastases to lymph nodes beyond the field of resection
Patients must have evaluable disease
Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to radiation simulation, postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential) and nonlactating, and men and women must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed
Eastern Cooperative Oncology Group (ECOG) performance status determined to be between 0 and 1
Absolute neutrophil count (ANC) >= 1,500/ul
Platelets (PLT) >= 100,000/ul
Subjects must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up
Bilirubin less then 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN

You may not qualify if…

Patients who have had any prior therapy for pancreatic cancer
Concurrent chemotherapy or biologic therapy
A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
Scleroderma or active connective tissue disease
Active inflammatory bowel disease
Serious, active infections requiring treatment with IV antibiotics
Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements

Where it is running

Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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