Lokal Fortgeschrittenes Pankreas-Karzinom: Stereotaktische Radiotherapie Gefolfgt Von Gemox-Chemotherapie
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Lokal Fortgeschrittenes Pankreas-Karzinom: Stereotaktische Radiotherapie Gefolfgt Von Gemox-Chemotherapie
OBJECTIVES:
Primary
- Determine the clinical response rate in patients undergoing surgery for locally
advanced pancreatic cancer treated with stereotactic radiotherapy, gemcitabine
hydrochloride, and oxaliplatin.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the time to disease progression in patients treated with this regimen.
- Determine the time to death in patients treated with this regimen.
- Determine perioperative morbidity and mortality in patients treated with this regimen.
- Determine the rate of R0 resections in patients treated with this regimen.
- Determine the histologic response rate in these patients.
OUTLINE:
- Neoadjuvant therapy: Patients undergo hypofractionated, stereotactic radiotherapy on
days 1-5. Patients also receive gemcitabine hydrochloride IV over 100 minutes on day 1
and oxaliplatin IV over 120 minutes on day 2. Treatment with gemcitabine hydrocloride
and oxaliplatin repeats every 2 weeks for 3 courses.
- Surgery: Patients with resectable disease undergo tumor resection. Patients with
unresectable disease undergo a second course of neoadjuvant chemoradiotherapy followed
by resection.
- Adjuvant therapy: Beginning 3-4 weeks after surgery, patients receive 3 more courses of
chemotherapy as in neoadjuvant therapy.
After completion of study treatment, patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas or
intrapancreatic bile duct carcinoma
- Overall view of image morphology and CA19-9 (< 500 U/L) demonstrating pancreatic
cancer allowed if histologic/cytologic confirmation is unavailable
- Locally advanced disease, meeting 1 of the following criteria:
- Uncertain R0 resectability dependant on relation to portal vein, sinus
confluens, superior mesenteric artery, and superior mesenteric vein (e.g.,
contact with portal vein, superior mesenteric vein, or arterial vessels, but <
180° encasement)
- Unresectable pancreatic cancer (e.g., contact with portal vein, superior
mesenteric artery or arterial vessels, > 180° encasement)
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 1 cm by
spiral CT scan or MRI
- Patients with no measurable disease may be assessed for feasibility only
- No distant metastases
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%
- WBC ≥ 3,000/mm³
- Granulocyte count ≥ 2,000/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine clearance > 30 mL/min
- Bilirubin ≤ 3.0 times upper limit of normal
- AST and ALT ≤ 2.5 times normal
- Alkaline phosphatase ≤ 2.5 times normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No secondary malignancy within the past 5 years that was not curatively treated
- No known intolerance to any of the study drugs
- No preexisting polyneuropathy > grade 1
- No active uncontrolled infection
- No cardiac insufficiency despite optimal medication
- No New York Heart Association class III or IV congestive heart failure
- LVEF ≥ 50% OR shortening fraction ≥ 25%
- No angina pectoris (at rest or under stress) unexplained by interventional cardiology
within the past 6 months
- No myocardial infarction within the past 6 months
- No uncontrolled diabetes mellitus
- No other existing serious medical impairments that would preclude study compliance
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
- No prior radiotherapy to the abdomen
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical response rate as assessed by RECIST criteria
Safety Issue:
No
Principal Investigator
Florian Lordick, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Technische Universität München
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
CDR0000515934
NCT ID:
NCT00425841
Start Date:
May 2006
Completion Date:
December 2009
Related Keywords:
- Pancreatic Cancer
- adenocarcinoma of the pancreas
- stage III pancreatic cancer
- stage II pancreatic cancer
- Pancreatic Neoplasms
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