Margin-Intense Combo Therapy in Pts w/Potentially Resectable Pancreatic Cancer

NCT ID: NCT01025882

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-02-18

Brief Summary

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.

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regimen 1

Patients undergo a single fraction of margin-intensive stereotactic body radiotherapy (SBRT) on day 1. Patients undergo pancreatoduodenectomy between days 15-43.

Group Type: EXPERIMENTAL

stereotactic body radiation therapy

Intervention Type: RADIATION

Given as a single fraction

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.

Group Type: EXPERIMENTAL

gemcitabine hydrochloride

Intervention Type: DRUG

Given IV

stereotactic body radiation therapy

Intervention Type: RADIATION

Given as a single fraction

Interventions

gemcitabine hydrochloride

Given IV

Intervention Type: DRUG

stereotactic body radiation therapy

Given as a single fraction

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John C. Mansour, MD

Role: PRINCIPAL_INVESTIGATOR

Simmons Cancer Center

Locations

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, United States

Countries

United States

Other Identifiers

CDR0000657523

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2011-01117

Identifier Type: REGISTRY

Identifier Source: secondary_id

SCCC-01209

Identifier Type: -

Identifier Source: org_study_id