- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01372735
Trial of Neoadjuvant Short Course IMRT Followed by Surgery and IORT for Resectable Pancreatic Cancer (NEOPANC)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Falk FF Roeder, MD
- Phone Number: +4962215639587
- Email: Falk.Roeder@med.uni-heidelberg.de
Study Contact Backup
- Name: Peter E Huber, MD, PhD
- Phone Number: +496221422515
- Email: P.Huber@dkfz.de
Study Locations
-
-
-
Heidelberg, Germany, 69120
- Department of radiation oncology, University Hospital Heidelberg
-
Contact:
- Falk FF Roeder, MD
- Phone Number: +4962215639587
- Email: Falk.Roeder@med.uni-heidelberg.de
-
Principal Investigator:
- Falk FF Roeder, MD
-
Sub-Investigator:
- Juergen Debus, MD, PhD
-
Heidelberg, Germany, 69120
- Department of Radiation Oncology, German Cancer Research Center
-
Contact:
- Peter E Huber, MD, PhD
- Phone Number: +496221422515
- Email: P.Huber@dkfz.de
-
Principal Investigator:
- Peter E Huber, MD, PhD
-
Sub-Investigator:
- Carmen Timke, MD
-
Heidelberg, Germany, 69120
- Department of surgery, university of Heidelberg
-
Contact:
- Jens Werner, MD
- Phone Number: +4962215639692
- Email: Jens.Werner@med.uni-heidelberg.de
-
Principal Investigator:
- Jens Werner, MD
-
Sub-Investigator:
- Markus W Buechler, MD
-
Sub-Investigator:
- Lutz Schneider, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Local recurrence rate
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free Survival
Time Frame: up to 5 years from first day of treatment
|
up to 5 years from first day of treatment
|
Overall Survival
Time Frame: up to 5 years from first day of treatment
|
up to 5 years from first day of treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEOPANC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pancreatic Neoplasms
-
Memorial Sloan Kettering Cancer CenterRecruitingPancreatic Cancer | Pancreatic Cancer Metastatic | Pancreatic Cancer Stage IV | Metastatic Pancreatic Carcinoma | Metastatic Pancreatic Adenocarcinoma | Pancreatic Carcinoma | Metastatic Pancreatic Cancer | Pancreatic Cancer Non-resectable | Metastatic Pancreatic Ductal Adenocarcinoma | Pancreatic Carcinoma... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CelgeneWithdrawnPancreatic Ductal Adenocarcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedPancreatic Adenocarcinoma | Resectable Pancreatic Cancer | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer | Poorly Differentiated Malignant Neoplasm | Undifferentiated Pancreatic CarcinomaUnited States
-
University of UtahNovartis PharmaceuticalsRecruitingMetastatic Pancreatic Carcinoma | Unresectable Pancreatic Carcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic CancerUnited States
-
University of OxfordNational Institute for Health Research, United Kingdom; ImunonWithdrawnPancreatic Cancer Metastatic | Pancreatic Ductal Adenocarcinoma | Pancreatic Cancer Stage IV | Pancreatic Cancer Non-resectableUnited Kingdom
-
Mayo ClinicNational Cancer Institute (NCI)CompletedAdvanced Pancreatic Carcinoma | Metastatic Pancreatic Carcinoma | Stage II Pancreatic Cancer AJCC v8 | Stage III Pancreatic Cancer AJCC v8 | Stage IV Pancreatic Cancer AJCC v8 | Unresectable Pancreatic Carcinoma | Pancreatic Neoplasm | Locally Advanced Pancreatic CarcinomaUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science University; Celgene CorporationCompletedPancreatic Adenocarcinoma | Resectable Pancreatic CarcinomaUnited States
-
The First Affiliated Hospital with Nanjing Medical...RecruitingLocally Advanced Pancreatic Adenocarcinoma | Metastatic Pancreatic Cancer | Pancreatic NeoplasmChina
-
Maria LiljeforsKarolinska University Hospital; Karolinska Institutet; CelgeneCompletedPancreatic Ductal Adenocarcinoma | Pancreatic Carcinoma MetastaticSweden
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer
Clinical Trials on neoadjuvant short course IMRT
-
Jiangsu Cancer Institute & HospitalRecruitingLocally Advanced Esophageal CarcinomaChina
-
Tata Memorial CentreNot yet recruitingRectal Neoplasms
-
Cancer Institute and Hospital, Chinese Academy...RecruitingCancer, RectumChina
-
Karolinska InstitutetThe Swedish Research Council; Swedish Cancer SocietyCompleted
-
International Atomic Energy AgencyCompletedEsophageal CancerChina, Canada, Croatia, India, Pakistan, South Africa, Thailand
-
Jules Bordet InstituteNot yet recruitingOlder People | Locally Advanced Rectal CancerBelgium
-
Trans Tasman Radiation Oncology GroupAustralasian Gastro-Intestinal Trials Group; Colorectal Surgical Society of... and other collaboratorsCompletedAdenocarcinoma of RectumAustralia, New Zealand
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaCompleted
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaCompletedPalliative Care
-
Jong Hoon LeeNational Cancer Center, Korea; Samsung Medical Center; Seoul National University...UnknownRectal CancerKorea, Republic of