Back to resultsStereotactic Radiation Therapy and Combination Chemotherapy in Treating Patients Undergoing Surgery for Locally Advanced Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
gemcitabine hydrochloride
oxaliplatin
adjuvant therapy
neoadjuvant therapy
hypofractionated radiation therapy
stereotactic radiosurgery
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage III pancreatic cancer, stage II pancreatic cancer
Eligibility 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
Sites / Locations
- Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Outcomes
Primary Outcome Measures
Clinical response rate as assessed by RECIST criteria
Secondary Outcome Measures
Toxicity as assessed by NCI-CTC criteria
Time to progression
Time to death
Perioperative morbidity and mortality
Rate of R0 resections
Histologic response rate
Full Information
NCT ID
NCT00425841
First Posted
January 19, 2007
Last Updated
December 11, 2012
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT00425841
Brief Title
Stereotactic Radiation Therapy and Combination Chemotherapy in Treating Patients Undergoing Surgery for Locally Advanced Pancreatic Cancer
Official Title
Lokal Fortgeschrittenes Pankreas-Karzinom: Stereotaktische Radiotherapie Gefolfgt Von Gemox-Chemotherapie
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, stage III pancreatic cancer, stage II pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
29 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
hypofractionated radiation therapy
Intervention Type
Radiation
Intervention Name(s)
stereotactic radiosurgery
Primary Outcome Measure Information:
Title
Clinical response rate as assessed by RECIST criteria
Secondary Outcome Measure Information:
Title
Toxicity as assessed by NCI-CTC criteria
Title
Time to progression
Title
Time to death
Title
Perioperative morbidity and mortality
Title
Rate of R0 resections
Title
Histologic response rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florian Lordick, MD
Organizational Affiliation
Technical University of Munich
Official's Role
Study Chair
Facility Information:
Facility Name
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
City
Munich
ZIP/Postal Code
D-81675
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Stereotactic Radiation Therapy and Combination Chemotherapy in Treating Patients Undergoing Surgery for Locally Advanced Pancreatic Cancer
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