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

NCT01372735 | Unknown Phase 1

• 1 other identifier: NEOPANC
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pancreatic Neoplasms

Keywords

pancreatic cancer; intensity-modulated radiation therapy; intraoperative radiation therapy

Outcome Measures

Primary Outcomes (1)

• Local recurrence rate

  1 year

Secondary Outcomes (2)

• Progression-free Survival

  up to 5 years from first day of treatment

• Overall Survival

  up to 5 years from first day of treatment

Interventions

neoadjuvant short course IMRT RADIATION

neoadjuvant short course intensity-modulated radiotherapy, single dose 5 Gy, total dose 25 Gy (5x5 schedule) to primary tumor and regional lymph nodes

IORT RADIATION

intraoperative radiation therapy during resection, 15 Gy (to 90% isodose) to tumor bed

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• German Cancer Research Center: collaborator

Study Sites (3)

Department of Radiation Oncology, German Cancer Research Center

Heidelberg, 69120, Germany

Location

Department of Radiation Oncology, University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

Department of Surgery, University of Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (1)

• 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 x 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.

  PMID: 22443802 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Falk FF Roeder, MD

CONTACT

+4962215639587; Falk.Roeder@med.uni-heidelberg.de

Peter E Huber, MD, PhD

CONTACT

+496221422515; P.Huber@dkfz.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 14, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2017
• Last Updated: June 14, 2011

Record last verified: 2011-06

Locations

DE (3)