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Lokal Fortgeschrittenes Pankreas-Karzinom: Stereotaktische Radiotherapie Gefolfgt Von Gemox-Chemotherapie

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

Lokal Fortgeschrittenes Pankreas-Karzinom: Stereotaktische Radiotherapie Gefolfgt Von Gemox-Chemotherapie



- Determine the clinical response rate in patients undergoing surgery for locally
advanced pancreatic cancer treated with stereotactic radiotherapy, gemcitabine
hydrochloride, and oxaliplatin.


- 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.


- 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


- 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


- 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


- No prior chemotherapy

- No prior radiotherapy to the abdomen

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical response rate as assessed by RECIST criteria

Safety Issue:


Principal Investigator

Florian Lordick, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Technische Universität München


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




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