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

Sponsor

Technische Universität München (Other)

Overall Status

Completed

CT.gov ID

NCT00425841

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

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

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

29 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2006

Actual Study Completion Date :

Dec 1, 2009

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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