Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT01372735
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT01372735
Study Brief:
Protocol Section:
NCT01372735