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

NCT ID: NCT01372735

Last Updated: 2011-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2017-08-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: RADIATION

IORT

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

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Cancer Research Center

OTHER

Sponsor Role: collaborator

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Department of Radiation Oncology, University of Heidelberg

Principal Investigators

Falk FF Roeder, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiation Oncology, University Hospital Heidelberg

Peter E Huber, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiation Oncology, German Cancer Research Center (DKFZ)

Jens Werner, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, University Hospital of Heidelberg

Locations

Department of Radiation Oncology, German Cancer Research Center

Heidelberg, , Germany

Department of Radiation Oncology, University Hospital Heidelberg

Heidelberg, , Germany

Department of Surgery, University of Heidelberg

Heidelberg, , Germany

Countries

Germany

Central Contacts

Falk FF Roeder, MD

Role: CONTACT

Falk.Roeder@med.uni-heidelberg.de

+4962215639587

Peter E Huber, MD, PhD

Role: CONTACT

P.Huber@dkfz.de

+496221422515

Facility Contacts

Peter E Huber, MD, PhD

Role: primary

P.Huber@dkfz.de

+496221422515

Falk FF Roeder, MD

Role: primary

Falk.Roeder@med.uni-heidelberg.de

+4962215639587

Jens Werner, MD

Role: primary

Jens.Werner@med.uni-heidelberg.de

+4962215639692

References

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.

Reference Type: DERIVED

PMID: 22443802 (View on PubMed)

Other Identifiers

NEOPANC

Identifier Type: -

Identifier Source: org_study_id