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Randomised Phase I/II Trial in Order to Evaluate the Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Neoadjuvant Low-Dose-Radiation Therapy in Primarily Resectable Pancreatic Cancer


Phase 1/Phase 2
50 Years
N/A
Open (Enrolling)
Both
Primarily Resectable Pancreatic Cancer

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Trial Information

Randomised Phase I/II Trial in Order to Evaluate the Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Neoadjuvant Low-Dose-Radiation Therapy in Primarily Resectable Pancreatic Cancer


Inclusion Criteria:



- Radiological diagnosis of resectable pancreatic carcinoma is required prior to
treatment. Potentially resectable is defined as no extrapancreatic disease, no
evidence (on CT) of involvement of the celiac axis or superior mesenteric artery, no
evidence (on CT or MRI) of occlusion of the superior mesenteric vein or superior
mesenteric-portal venous confluence.

- No evidence of metastatic disease as determined by chest CT scan, abdominal CT scan
(or MRI)

- 18 years of age or older

- ASA Performance status of 1 to 3

- Women of child bearing potential must practice adequate contraception and refrain
from breast feeding. Female patients must have a negative pregnancy test within 7
days of treatment

- Informed consent

Exclusion Criteria:

- Locally irresectable pancreatic cancer

- distant metastases

- medically unfit for surgery

- Pregnant or lactating women

- prior chemotherapy or radiation treatment

- Other serious uncontrolled medical conditions that the investigator feels might
compromise study participation

- Unwillingness to participate or inability to comply with the protocol for the
duration of the study

- Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment,
without complete recovery

- Participation in other interventional trials

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumoral activity

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Peter E. Huber, Prof. PhD MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

German Cancer Research Centre and Clinic for Radiation Oncology of the University of Heidelberg

Authority:

Germany: Federal Office for Radiation Protection

Study ID:

IMPACT2010

NCT ID:

NCT01027221

Start Date:

November 2009

Completion Date:

December 2012

Related Keywords:

  • Primarily Resectable Pancreatic Cancer
  • Low Dose Radiation
  • pancreatic cancer
  • Immunostimulation
  • Pancreatic Neoplasms

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