Trial of Neoadjuvant Short Course IMRT Followed by Surgery and IORT for Resectable Pancreatic Cancer (NEOPANC)

June 10, 2011 updated by: University Hospital Heidelberg

Clinical Phase I/II Trial to Investigate Neoadjuvant Intensity-Modulated Short Term Radiation Therapy (5x5 Gy) and Intraoperative Radiation Therapy (15 Gy) in Patients With Primarily Resectable Pancreatic Cancer - NEOPANC

The current standard treatment for patients with primarily resectable pancreatic tumors consists of surgery followed by adjuvant chemotherapy. But even in this prognostic favourable group, long term survival is disappointing because of high local and distant failure rates. Postoperative chemoradiation has shown improved local control and overall survival compared to surgery alone but the value of additional radiation has been questioned in case of adjuvant chemotherapy. However, there remains a strong rationale for the addition of radiation therapy considering the high rates of microscopically incomplete resections after surgery. As postoperative administration of radiation therapy has some general disadvantages, neoadjuvant and intraoperative approaches theoretically offer benefits in terms of dose escalation, reduction of toxicity and patients comfort especially if hypofractionated regimens with highly conformal techniques like intensity-modulated radiation therapy are considered.

Therefore the NEOPANC trial has been designed as a prospective, one armed single center study to investigate a combination of neoadjuvant short course intensity-modulated radiation therapy (5x5 Gy) in combination with surgery and intraoperative radiation therapy (15 Gy) followed by adjuvant chemotherapy according to german treatment guidelines in patients with primarily resectable pancreatic cancer. The primary objectives of the NEOPANC trial are to evaluate the general feasibility of this approach and the local recurrence rate after one year. Secondary endpoints are progression-free survival, overall survival, acute and late toxicity, postoperative morbidity and mortality and quality of life.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Peter E Huber, MD, PhD
  • Phone Number: +496221422515
  • Email: P.Huber@dkfz.de

Study Locations

      • Heidelberg, Germany, 69120
        • Department of radiation oncology, University Hospital Heidelberg
        • Contact:
        • Principal Investigator:
          • Falk FF Roeder, MD
        • Sub-Investigator:
          • Juergen Debus, MD, PhD
      • Heidelberg, Germany, 69120
        • Department of Radiation Oncology, German Cancer Research Center
        • Contact:
          • Peter E Huber, MD, PhD
          • Phone Number: +496221422515
          • Email: P.Huber@dkfz.de
        • Principal Investigator:
          • Peter E Huber, MD, PhD
        • Sub-Investigator:
          • Carmen Timke, MD
      • Heidelberg, Germany, 69120
        • Department of surgery, university of Heidelberg
        • Contact:
        • Principal Investigator:
          • Jens Werner, MD
        • Sub-Investigator:
          • Markus W Buechler, MD
        • Sub-Investigator:
          • Lutz Schneider, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • written informed consent
  • histologically confirmed, primary pancreatic cancer of the pancreatic head
  • judged as gross completely resectable
  • absence of lymph node metastases at the splenic hilum or along the pancreatic tail
  • no evidence of distant metastases
  • age > 50 years
  • Karnofsky performance score ≥ 70%
  • adequate bone marrow function (neutrophils > 2000/µl, platelets > 100000/µl)
  • adequate renal function (Creatinine < 1.5 mg/dl)
  • adequate liver function

Exclusion Criteria:

  • missing written informed consent
  • missing histological conformation of pancreatic cancer
  • judged as gross incomplete or not resectable
  • pancreatic cancer located in the pancreatic corpus or tail
  • recurrent pancreatic cancer
  • incomplete staging
  • presence of lymph node metastases along the pancreatic tail or splenic hilum
  • presence of distant metastases
  • prior radiation therapy to the upper abdominal region
  • neoadjuvant chemotherapy or immunotherapy
  • participation in another clinical interventional study
  • age ≤ 50 years
  • other previous or active malignancy (excluding basal cell carcinoma, carcinoma in situ of the cervix)
  • Karnofsky performance score <70%
  • inadequate bone marrow function
  • inadequate renal or liver function
  • any other disease or situation, which generally prohibits the use of major surgery or radiation therapy according to the judgement of a surgeon or radiation oncologist
  • inability to participate in regular follow up
  • pregnancy, inability or incompliance for adequate contraception
  • missing ability to give informed consent
  • legal custody

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Local recurrence rate
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free Survival
Time Frame: up to 5 years from first day of treatment
up to 5 years from first day of treatment
Overall Survival
Time Frame: up to 5 years from first day of treatment
up to 5 years from first day of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Falk FF Roeder, MD, Department of radiation oncology, University Hospital Heidelberg
  • Principal Investigator: Peter E Huber, MD, PhD, Department of Radiation Oncology, German Cancer Research Center (DKFZ)
  • Principal Investigator: Jens Werner, MD, Department of Surgery, University Hospital of Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

June 9, 2011

First Submitted That Met QC Criteria

June 10, 2011

First Posted (Estimate)

June 14, 2011

Study Record Updates

Last Update Posted (Estimate)

June 14, 2011

Last Update Submitted That Met QC Criteria

June 10, 2011

Last Verified

June 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Neoplasms

Clinical Trials on neoadjuvant short course IMRT

Subscribe