Clinical trial · Interventional
Low Dose Radiation to Improve T-Cell Infiltration in Pancreatic Cancer
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
NCT01027221CI-TRIAL-00052214IMPACT2010completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primarily Resectable Pancreatic Cancer | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neoadjuvant photon radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- 0
- description
- primarily resectable pancreatic cancer patients
- type
- ACTIVE_COMPARATOR
- label
- 0,5 Gy
- description
- neoadjuvant Radiation of 0,5 Gy two days before resection
- interventionNames
- Radiation: neoadjuvant photon radiation
- type
- ACTIVE_COMPARATOR
- label
- 2 Gy
- description
- neoadjuvant Radiation of 2 Gy 2 days before resection
- interventionNames
- Radiation: neoadjuvant photon radiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTimke C, Winnenthal HS, Klug F, Roeder FF, Bonertz A, Reissfelder C, Rochet N, Koch M, Tjaden C, Buechler MW, Debus J, Werner J, Beckhove P, Weitz J, Huber PE. Randomized controlled phase I/II study to investigate immune stimulatory effects by low dose radiotherapy in primarily operable pancreatic cancer. BMC Cancer. 2011 Apr 13;11:134. doi: 10.1186/1471-2407-11-134. PMID 21489291