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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00425841
• Other study ID #: CDR0000515934
• Secondary ID: KRDI-TUM-STRATEG
• Status: Completed
• Phase: Phase 2
• First received: January 19, 2007
• Last updated: December 11, 2012
• Start date: May 2006
• Est. completion date: December 2009

Study information

• Verified date: December 2012
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

• oxaliplatin

Procedure:
• adjuvant therapy

• neoadjuvant therapy

Radiation:
• hypofractionated radiation therapy

• stereotactic radiosurgery

Locations

Country	Name	City	State
Germany	Klinikum Rechts Der Isar - Technische Universitaet Muenchen	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response rate as assessed by RECIST criteria			No
Secondary	Toxicity as assessed by NCI-CTC criteria			Yes
Secondary	Time to progression			No
Secondary	Time to death			No
Secondary	Perioperative morbidity and mortality			No
Secondary	Rate of R0 resections			No
Secondary	Histologic response rate			No