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Phase I Study of Margin-Intense Combination Therapy for Patients With Potentially Resectable Pancreatic Adenocarcinoma

Phase 1
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

Phase I Study of Margin-Intense Combination Therapy for Patients With Potentially Resectable Pancreatic Adenocarcinoma


- 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

- 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.

Inclusion Criteria


- 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

- Tumor encases > 180 degrees of the circumference of the superior mesenteric

- 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


- 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

- 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

- 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 significant infection or other coexisting medical condition that would preclude
study therapy

- No gastrointestinal fistula or perforation within the past 10 years


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Preoperative treatment-related toxicity, defined as adverse events occurring prior to surgical resection

Safety Issue:


Principal Investigator

John C. Mansour, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Simmons Cancer Center



Study ID:




Start Date:

October 2009

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • adenocarcinoma of the pancreas
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • Adenocarcinoma
  • Pancreatic Neoplasms



Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390