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

Pancreatic Neoplasms Clinical Trial

— NEOPANC  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01372735
• Other study ID #: NEOPANC
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: June 9, 2011
• Last updated: June 10, 2011
• Start date: August 2011
• Est. completion date: August 2017

Study information

• Verified date: June 2011
• Source: University Hospital Heidelberg
• Contact: Falk FF Roeder, MD
• Phone: +4962215639587
• Email: Falk.Roeder[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Office for Radiation Protection
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: August 2017
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Germany	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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Heidelberg	German Cancer Research Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local recurrence rate		1 year	No
Secondary	Progression-free Survival		up to 5 years from first day of treatment	No
Secondary	Overall Survival		up to 5 years from first day of treatment	No