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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


Phase 1/Phase 2
50 Years
N/A
Not Enrolling
Both
Pancreatic Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Local recurrence rate

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Falk FF Roeder, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Radiation Oncology, University Hospital Heidelberg

Authority:

Germany: Federal Office for Radiation Protection

Study ID:

NEOPANC

NCT ID:

NCT01372735

Start Date:

August 2011

Completion Date:

August 2017

Related Keywords:

  • Pancreatic Neoplasms
  • pancreatic cancer
  • intensity-modulated radiation therapy
  • intraoperative radiation therapy
  • Neoplasms
  • Pancreatic Neoplasms

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