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

This study is not yet open for participant recruitment.
Verified June 2011 by University Hospital Heidelberg
Sponsor:
Collaborator:
German Cancer Research Center
Information provided by:
University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01372735
First received: June 9, 2011
Last updated: June 10, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Pancreatic Neoplasms
 Radiation: neoadjuvant short course IMRT
Radiation: IORT
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • Local recurrence rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: up to 5 years from first day of treatment ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: up to 5 years from first day of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: August 2011
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: neoadjuvant short course IMRT
    neoadjuvant short course intensity-modulated radiotherapy, single dose 5 Gy, total dose 25 Gy (5x5 schedule) to primary tumor and regional lymph nodes
    Radiation: IORT
    intraoperative radiation therapy during resection, 15 Gy (to 90% isodose) to tumor bed
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372735

Contacts
Contact: Falk FF Roeder, MD +4962215639587 Falk.Roeder@med.uni-heidelberg.de
Contact: Peter E Huber, MD, PhD +496221422515 P.Huber@dkfz.de

Locations
Germany
Department of Radiation Oncology, University Hospital Heidelberg Not yet recruiting
Heidelberg, Germany, 69120
Contact: Falk FF Roeder, MD     +4962215639587     Falk.Roeder@med.uni-heidelberg.de    
Principal Investigator: Falk FF Roeder, MD            
Sub-Investigator: Juergen Debus, MD, PhD            
Department of Radiation Oncology, German Cancer Research Center Not yet recruiting
Heidelberg, Germany, 69120
Contact: Peter E Huber, MD, PhD     +496221422515     P.Huber@dkfz.de    
Principal Investigator: Peter E Huber, MD, PhD            
Sub-Investigator: Carmen Timke, MD            
Department of Surgery, University of Heidelberg Not yet recruiting
Heidelberg, Germany, 69120
Contact: Jens Werner, MD     +4962215639692     Jens.Werner@med.uni-heidelberg.de    
Principal Investigator: Jens Werner, MD            
Sub-Investigator: Markus W Buechler, MD            
Sub-Investigator: Lutz Schneider, MD            
Sponsors and Collaborators
University Hospital Heidelberg
German Cancer Research Center
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
  More Information

No publications provided by University Hospital Heidelberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Falk Roeder, Department of Radiation Oncology, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01372735     History of Changes
Other Study ID Numbers: NEOPANC
Study First Received: June 9, 2011
Last Updated: June 10, 2011
Health Authority: Germany: Federal Office for Radiation Protection

Keywords provided by University Hospital Heidelberg:
pancreatic cancer
intensity-modulated radiation therapy
intraoperative radiation therapy

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013