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RT-054: A Phase I Study of Neoadjuvant Hypofractionated Chemoradiation Plus Radiosurgical Boost for Patients With Borderline Resectable and Locally Advanced Unresectable Pancreatic Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Stage IIB Pancreatic Cancer, Stage III Pancreatic Cancer

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Trial Information

RT-054: A Phase I Study of Neoadjuvant Hypofractionated Chemoradiation Plus Radiosurgical Boost for Patients With Borderline Resectable and Locally Advanced Unresectable Pancreatic Cancer


PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) of a radiosurgery boost added to
hypofractionated chemoradiation in patients with borderline resectable or unresectable
pancreatic cancer.

SECONDARY OBJECTIVES:

I. To determine the effect of a radiosurgery boost added to hypofractionated chemoradiation
on surgical morbidity (specifically, healing of the surgical anastomoses and abdominal
wounds and late hemorrhage from blood vessels in the field) in patients with advanced
borderline resectable (BLR) or unresectable pancreatic cancer.

II. To evaluate the utility of diffusion-weighted magnetic resonance imaging (MRI) as an
assessment of treatment response after chemoradiation followed by radiosurgery.

III. To determine the feasibility of collecting tissue for immunohistochemistry (IHC)
analysis via endoscopic ultrasound or computed tomography (CT)-guided fine needle
aspiration.

IV. To utilize pathologic response rates in dose escalated regions, hypofractionated
regions, and the dose gradient region in between to better characterize the radiobiologic
response of pancreatic cancer to radiation dose escalation.

OUTLINE: This is a dose-escalation study of radiosurgery.

Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes once weekly
and undergo hyperfractionated intensity-modulated radiation therapy (IMRT) 5 days a week in
weeks 1-3. Patients then undergo a single fraction of radiosurgery boost in week 5 and then
receive gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 6-8. Treatment
continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 2 years, and then annually thereafter.


Inclusion Criteria:



- 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

- Serum creatinine < 1.5 x ULN

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD defined as the dose level in which 1 out of 6 patients observes dose-limiting toxicity (DLT) assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Outcome Time Frame:

Week 5

Safety Issue:

Yes

Principal Investigator

Joshua Meyer

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-046

NCT ID:

NCT01739439

Start Date:

May 2013

Completion Date:

January 2015

Related Keywords:

  • Acinar Cell Adenocarcinoma of the Pancreas
  • Duct Cell Adenocarcinoma of the Pancreas
  • Stage IIB Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms
  • Carcinoma, Acinar Cell

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111