Stereotactic Body Radiation Therapy With or Without Gemcitabine Hydrochloride in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01025882
First received: December 3, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving stereotactic body radiation therapy together with gemcitabine hydrochloride may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects of stereotactic body radiation therapy when given with or without gemcitabine hydrochloride in treating patients with pancreatic cancer that can be removed by surgery.


Condition Intervention Phase
Pancreatic Cancer
Drug: gemcitabine hydrochloride
Radiation: stereotactic body radiation therapy
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of Margin-Intense Combination Therapy for Patients With Potentially Resectable Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Preoperative treatment-related toxicity, defined as adverse events occurring prior to surgical resection [ Designated as safety issue: Yes ]
  • Postoperative surgical morbidity, defined as all other adverse events occurring within 90 days of surgery [ Designated as safety issue: Yes ]
  • Total dose of chemotherapy and radiotherapy delivered [ Designated as safety issue: No ]
  • Pre-treatment and post-treatment characteristics of the primary tumor on preoperative axial imaging including, but not limited to, tumor size, percentage of encasement/abutment of mesenteric vessels, and progression of disease [ Designated as safety issue: No ]
  • Postoperative complications including, but not limited to, need for reoperation, need for interventional radiology fluid collection drainage, systemic infection, wound infection, prolonged ICU stay, and delayed gastric emptying [ Designated as safety issue: No ]
  • Operative drain amylase at days 3 and 5 postoperatively [ Designated as safety issue: No ]
  • Length of hospital stay following pancreatic resection [ Designated as safety issue: No ]
  • Degree of histologic response of tumor in the resected specimen [ Designated as safety issue: No ]
  • Tumor samples for RNA and protein harvesting (when possible) from pretreatment biopsies and surgical specimens [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2009
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regimen 1
Patients undergo a single fraction of margin-intensive stereotactic body radiotherapy (SBRT) on day 1. Patients undergo pancreatoduodenectomy between days 15-43.
Radiation: stereotactic body radiation therapy
Given as a single fraction
Experimental: Regimen 2
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Patients undergo a single fraction of SBRT between days 21-28 followed by pancreatoduodenectomy between days 35-63.
Drug: gemcitabine hydrochloride
Given IV
Radiation: stereotactic body radiation therapy
Given as a single fraction

Detailed Description:

OBJECTIVES:

  • To demonstrate the feasibility and safety of administering margin-intensive stereotactic body radiotherapy together with preoperative gemcitabine hydrochloride to patients with resectable pancreatic adenocarcinoma.

OUTLINE: This is a multicenter, dose-escalation study of gemcitabine hydrochloride. Patients receive 1 of 2 treatment regimens.

  • Regimen 1: Patients undergo a single fraction of margin-intensive stereotactic body radiotherapy (SBRT) on day 1. Patients undergo pancreatoduodenectomy between days 15-43.
  • Regimen 2: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Patients undergo a single fraction of SBRT between days 21-28 followed by pancreatoduodenectomy between days 35-63.

After completion of study treatment, patients are followed periodically for 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Pathologically confirmed localized adenocarcinoma of the pancreas or distal common bile duct

    • Pancreatic ductal adenocarcinoma or peripancreatic cholangiocarcinoma
  • Resectable disease, as determined by the Gastrointestinal Cancer Working Group disease-oriented team

    • Criteria used to define unresectability will include, but not be limited to, the following:

      • Tumor encases > 180 degrees of the circumference of the superior mesenteric artery
      • Tumor encases the common hepatic artery with no anatomic option for reconstruction following segmental resection
      • Superior mesenteric vein occluded or encased with no option for reconstruction following segmental resection
      • Soft tissue infiltration of the retroperitoneum to the left of the superior mesenteric artery
  • All malignant disease must be encompassed within a single radiotherapy field
  • No metastatic disease

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute granulocyte count > 1,500/mm³
  • Platelet count > 100,000/mm³
  • Creatinine clearance > 50mL/min
  • AST and ALT < 5 times upper limit of normal
  • Serum bilirubin < 5 mg/dL (with biliary decompression)
  • INR ≤ 1.5
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Medically fit for pancreatic surgical resection, as determined by the investigating surgeons at the time of study enrollment
  • No evidence of an active second invasive malignancy outside the area of the pancreas or biliary system within the past 2 years, except for non-melanomatous skin cancer or carcinoma in situ of the breast, bladder, cervix, or uterus
  • No clinically significant cardiac disease, including the following:

    • Uncontrolled hypertension, defined as blood pressure > 160/90 mm Hg on medication
    • Myocardial infarction within the past 6 months
    • NYHA class II-IV congestive heart failure
    • Unstable symptomatic arrhythmia requiring medication (e.g., chronic atrial arrhythmia [atrial fibrillation or paroxysmal supraventricular tachycardia])

      • Atrial arrhythmia allowed provided it is well-controlled on stable medication
    • No current or recent (within the past 6 months) unstable angina
  • No recent (within the past 6 months) arterial thromboembolic events, including transient ischemic attack, cerebrovascular accident, or clinically significant peripheral artery disease
  • No evidence of bleeding diathesis or coagulopathy
  • No significant traumatic injury within the past 28 days
  • No serious nonhealing wound, ulcer, or currently healing fracture
  • No AIDS
  • No significant infection or other coexisting medical condition that would preclude study therapy
  • No gastrointestinal fistula or perforation within the past 10 years

PRIOR CONCURRENT THERAPY:

  • More than 2 years since prior chemotherapy (other than for pancreaticobiliary cancer)
  • More than 28 days since prior major surgical procedure or open biopsy
  • No prior intraabdominal radiotherapy in the planned field of pancreatic margin-intensive radiotherapy
  • No prior organ transplantation
  • No concurrent major surgical procedure
  • No other concurrent cytotoxic chemotherapy or anti-neoplastic biologic agents
  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: NCT01025882

Locations
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a    866-460-4673; 214-648-7097      
Sponsors and Collaborators
Simmons Cancer Center
Investigators
Principal Investigator: John C. Mansour, MD Simmons Cancer Center
Investigator: Marcella Aguilar Simmons Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: John C. Mansour, Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
ClinicalTrials.gov Identifier: NCT01025882     History of Changes
Other Study ID Numbers: CDR0000657523, SCCC-01209
Study First Received: December 3, 2009
Last Updated: December 3, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the pancreas
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
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 October 19, 2014