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Completed

NCT Number: NCT01027221

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

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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Key information

Conditions

Primarily Resectable Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic for General, Visceral and Transplantation Surgery, Heidelberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

neoadjuvant photon radiation

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

Primary outcomes

  1. 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

    Time frame: 1 year

    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

Secondary outcomes

  1. local control and recurrence patterns of pancreatic cancer relative to a standard as seen in historical controls

    Time frame: 5 years

    local control and recurrence patterns of pancreatic cancer relative to a standard as seen in historical controls

  2. surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment

    Time frame: 1 year

    surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment

  3. frequencies of tumor-reactive T-cells in blood and bone marrow

    Time frame: 2 years

    frequencies of tumor-reactive T-cells in blood and bone marrow

  4. expression of migration-relevant adhesion molecules on tumor endothelial cells

    Time frame: 2 years

    expression of migration-relevant adhesion molecules on tumor endothelial cells

  5. expression of proinflammatory cytokines and activation-dependent, immune-associated transcriptionally factors in tumors and blood

    Time frame: 2 years

    expression of proinflammatory cytokines and activation-dependent, immune-associated transcriptionally factors in tumors and blood

  6. quality of life according to the EORTC QoL questionnaire after 6, 12, 18 and 24 months

    Time frame: 3 years

    quality of life according to the EORTC QoL questionnaire after 6, 12, 18 and 24 months

Sponsors and collaborators

Lead sponsor

German Cancer Research Center

Other

Collaborators

  • Heidelberg University

Registry information

Official study title

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

Acronym: IMPACT2010

Important dates

Study start
2009
Primary completion
2019
Study completion
2019
First posted
Dec 7, 2009
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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