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
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: gemcitabine hydrochloride
Drug: oxaliplatin
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Radiation: hypofractionated radiation therapy
Radiation: stereotactic radiosurgery
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Lokal Fortgeschrittenes Pankreas-Karzinom: Stereotaktische Radiotherapie Gefolfgt Von Gemox-Chemotherapie

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Clinical response rate as assessed by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 29
Study Start Date: May 2006
Study Completion Date: December 2009
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425841

Locations
Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, Germany, D-81675
Sponsors and Collaborators
Technische Universität München
Investigators
Study Chair: Florian Lordick, MD Technische Universität München
  More Information

Additional Information:
No publications provided

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT00425841     History of Changes
Other Study ID Numbers: CDR0000515934, KRDI-TUM-STRATEGIE-STR-242-LOR, EU-20659
Study First Received: January 19, 2007
Last Updated: December 11, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität München:
adenocarcinoma of the pancreas
stage III pancreatic cancer
stage II pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 20, 2014