Stereotactic Radiation Therapy and Combination Chemotherapy in Treating Patients Undergoing Surgery for Locally Advanced Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00425841
First received: January 19, 2007
Last updated: December 11, 2012
Last verified: December 2012

January 19, 2007
December 11, 2012
May 2006
Not Provided
Clinical response rate as assessed by RECIST criteria [ Designated as safety issue: No ]
Clinical response rate as assessed by RECIST criteria
Complete list of historical versions of study NCT00425841 on ClinicalTrials.gov Archive Site
  • Toxicity as assessed by NCI-CTC criteria [ Designated as safety issue: Yes ]
  • Time to progression [ Designated as safety issue: No ]
  • Time to death [ Designated as safety issue: No ]
  • Perioperative morbidity and mortality [ Designated as safety issue: No ]
  • Rate of R0 resections [ Designated as safety issue: No ]
  • Histologic response rate [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI-CTC criteria
  • Time to progression
  • Time to death
  • Perioperative morbidity and mortality
  • Rate of R0 resections
  • Histologic response rate
Not Provided
Not Provided
 
Stereotactic Radiation Therapy and Combination Chemotherapy in Treating Patients Undergoing Surgery for Locally Advanced Pancreatic Cancer
Lokal Fortgeschrittenes Pankreas-Karzinom: Stereotaktische Radiotherapie Gefolfgt Von Gemox-Chemotherapie

RATIONALE: Stereotactic 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 and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving stereotactic radiation therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving stereotactic radiation therapy together with combination chemotherapy works in treating patients undergoing surgery for locally advanced pancreatic cancer.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: gemcitabine hydrochloride
  • Drug: oxaliplatin
  • Procedure: adjuvant therapy
  • Procedure: neoadjuvant therapy
  • Radiation: hypofractionated radiation therapy
  • Radiation: stereotactic radiosurgery
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
December 2009
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00425841
CDR0000515934, KRDI-TUM-STRATEGIE-STR-242-LOR, EU-20659
Not Provided
Technische Universität München
Technische Universität München
Not Provided
Study Chair: Florian Lordick, MD Technische Universität München
Technische Universität München
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP