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

Primary Purpose

Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Stage IIB Pancreatic Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
hyperfractionated radiation therapy
intensity-modulated radiation therapy
radiosurgery
diffusion-weighted magnetic resonance imaging
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acinar Cell Adenocarcinoma of the Pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fox Chase Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (chemoradiation and radiosurgery)

Arm Description

Patients receive gemcitabine hydrochloride IV over 30 minutes once weekly and undergo hyperfractionated 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 29, 2012
Last Updated
July 26, 2019
Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01739439
Brief Title
Chemoradiation and Radiosurgery Boost in Treating Patients With Locally Advance Pancreatic Cancer That May or May Not be Removed by Surgery
Official Title
RT-054: A Phase I Study of Neoadjuvant Hypofractionated Chemoradiation Plus Radiosurgical Boost for Patients With Borderline Resectable and Locally Advanced Unresectable Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
May 2013 (Actual)
Primary Completion Date
December 1, 2015 (Actual)
Study Completion Date
December 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Stage IIB Pancreatic Cancer, Stage III Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (chemoradiation and radiosurgery)
Arm Type
Experimental
Arm Description
Patients receive gemcitabine hydrochloride IV over 30 minutes once weekly and undergo hyperfractionated 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.
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Other Intervention Name(s)
dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
hyperfractionated radiation therapy
Intervention Description
Undergo hyperfractionated IMRT
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy
Other Intervention Name(s)
IMRT
Intervention Description
Undergo hyperfractionated IMRT
Intervention Type
Radiation
Intervention Name(s)
radiosurgery
Other Intervention Name(s)
radiation surgery
Intervention Description
Undergo radiosurgery boost
Intervention Type
Procedure
Intervention Name(s)
diffusion-weighted magnetic resonance imaging
Other Intervention Name(s)
diffusion-weighted MRI
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
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
Time Frame
Week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Meyer
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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