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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Fox Chase Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT01739439
First received: November 29, 2012
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Stage IIB Pancreatic Cancer
Stage III Pancreatic Cancer
Drug: gemcitabine hydrochloride
Radiation: hyperfractionated radiation therapy
Radiation: intensity-modulated radiation therapy
Radiation: radiosurgery
Procedure: diffusion-weighted magnetic resonance imaging
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

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 [ Time Frame: Week 5 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: May 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (chemoradiation and radiosurgery)
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.
Drug: gemcitabine hydrochloride
Given IV
Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • gemcitabine
  • Gemzar
Radiation: hyperfractionated radiation therapy
Undergo hyperfractionated IMRT
Radiation: intensity-modulated radiation therapy
Undergo hyperfractionated IMRT
Other Name: IMRT
Radiation: radiosurgery
Undergo radiosurgery boost
Other Name: radiation surgery
Procedure: diffusion-weighted magnetic resonance imaging
Correlative studies
Other Name: diffusion-weighted MRI

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739439

Locations
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Joshua E. Meyer    215-728-4790    joshua.meyer@fccc.edu   
Principal Investigator: Joshua E. Meyer         
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Principal Investigator: Joshua Meyer Fox Chase Cancer Center
  More Information

No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT01739439     History of Changes
Other Study ID Numbers: 12-046, NCI-2012-02729
Study First Received: November 29, 2012
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma, Acinar Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 22, 2014