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

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

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01025882
Enrollment
5
Registered
2009-12-04
Start date
2009-10-31
Completion date
2011-02-18
Last updated
2019-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer

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.

Interventions

DRUGgemcitabine hydrochloride

Given IV

RADIATIONstereotactic body radiation therapy

Given as a single fraction

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Length of hospital stay following pancreatic resection
Degree of histologic response of tumor in the resected specimen
Preoperative treatment-related toxicity, defined as adverse events occurring prior to surgical resection
Postoperative surgical morbidity, defined as all other adverse events occurring within 90 days of surgery
Total dose of chemotherapy and radiotherapy delivered
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
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
Operative drain amylase at days 3 and 5 postoperatively
Tumor samples for RNA and protein harvesting (when possible) from pretreatment biopsies and surgical specimens

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026