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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. (see Contacts and Locations)
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

June 9, 2011
June 10, 2011
August 2011
August 2013   (final data collection date for primary outcome measure)
Local recurrence rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01372735 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Trial of Neoadjuvant Short Course IMRT Followed by Surgery and IORT for Resectable Pancreatic Cancer
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Neoplasms
  • 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
Not Provided
Roeder F, Timke C, Saleh-Ebrahimi L, Schneider L, Hackert T, Hartwig W, Kopp-Schneider A, Hensley FW, Buechler MW, Debus J, Huber PE, Werner J. Clinical phase I/II trial to investigate neoadjuvant intensity-modulated short term radiation therapy (5 × 5 Gy) and intraoperative radiation therapy (15 Gy) in patients with primarily resectable pancreatic cancer - NEOPANC. BMC Cancer. 2012 Mar 23;12:112. doi: 10.1186/1471-2407-12-112.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
46
August 2017
August 2013   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact: Falk FF Roeder, MD +4962215639587 Falk.Roeder@med.uni-heidelberg.de
Contact: Peter E Huber, MD, PhD +496221422515 P.Huber@dkfz.de
Germany
 
NCT01372735
NEOPANC
No
Dr. Falk Roeder, Department of Radiation Oncology, University of Heidelberg
University Hospital Heidelberg
German Cancer Research Center
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
University Hospital Heidelberg
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP