Low Dose Radiation to Improve T-Cell Infiltration in Pancreatic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2019-09-30

Brief Summary

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Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximum number of tumor infiltrating T-cells.

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Detailed Description

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Conditions

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Primarily Resectable Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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0

primarily resectable pancreatic cancer patients

Group Type NO_INTERVENTION

No interventions assigned to this group

0,5 Gy

neoadjuvant Radiation of 0,5 Gy two days before resection

Group Type ACTIVE_COMPARATOR

neoadjuvant photon radiation

Intervention Type RADIATION

single fraction, four dimensions (4D) planned, image guided, Radiation at a dose of 0,5 Gy in Intensity modulated radiotherapy (IMRT)-technique 2 days before resection

2 Gy

neoadjuvant Radiation of 2 Gy 2 days before resection

Group Type ACTIVE_COMPARATOR

neoadjuvant photon radiation

Intervention Type RADIATION

single fraction, 4D-planned, image guided, 2 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection

5 Gy

neoadjuvant Radiation of 5 Gy 2 days before resection

Group Type ACTIVE_COMPARATOR

neoadjuvant photon radiation

Intervention Type RADIATION

single fraction, 4D-planned, image guided, 5 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection

Interventions

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neoadjuvant photon radiation

single fraction, four dimensions (4D) planned, image guided, Radiation at a dose of 0,5 Gy in Intensity modulated radiotherapy (IMRT)-technique 2 days before resection

Intervention Type RADIATION

neoadjuvant photon radiation

single fraction, 4D-planned, image guided, 2 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection

Intervention Type RADIATION

neoadjuvant photon radiation

single fraction, 4D-planned, image guided, 5 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection

Intervention Type RADIATION

Eligibility Criteria

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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
* American Society of Anesthesiologists (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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No