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

NCT00425841 | Completed Phase 2

• 3 other identifiers: CDR0000515934KRDI-TUM-STRATEGIE-STR-242-LOREU-20659
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage III pancreatic cancer; stage II pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Clinical response rate as assessed by RECIST criteria

Secondary Outcomes (6)

• Toxicity as assessed by NCI-CTC criteria

• Time to progression

• Time to death

• Perioperative morbidity and mortality

• Rate of R0 resections

Interventions

gemcitabine hydrochloride DRUG

oxaliplatin DRUG

adjuvant therapy PROCEDURE

neoadjuvant therapy PROCEDURE

hypofractionated radiation therapy RADIATION

stereotactic radiosurgery RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Oxaliplatin; Chemotherapy, Adjuvant; Neoadjuvant Therapy; Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Florian Lordick, MD

  Technical University of Munich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2007
• First Posted: January 23, 2007
• Study Start: May 1, 2006
• Study Completion: December 1, 2009
• Last Updated: December 12, 2012

Record last verified: 2012-12

Locations

DE (1)