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 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT03648632
Eligibility Criteria:
Inclusion Criteria:
* LAPC (Karolinska Type B, C or D1)
* Cytologically or histologically verified adenocarcinoma/carcinoma
* Prior combination chemotherapy for 2-6 months (unless contraindicated) and no sign of progressive disease
* The patient is medically operable (i.e. no co-morbidity which can preclude anaesthesia or surgery)
* World Health Organization performance status 0-1
* Age ≥ 18 years
* Adequate hepatic function: bilirubin \<3.0 x Upper Normal Limit, International Normalized Ratio \<1.6, Activated Partial Thromboplastin Time \< 1,5 x Upper Normal Limit. Patients with obstruction of bile duct or gut must be drained before start of therapy
* Oral and written informed consent must be obtained prior to registration with planned date of first treatment within 14 days from registration.
Exclusion Criteria:
* M1 disease
* Prior radiotherapy to abdominal cavity
* Pregnancy or breast-feeding. Fertile patients must use adequate contraceptives
* Severe uncontrolled concomitant illness (e.g. clinically significant cardiac disease or myocardial infarction within 12 months)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03648632
Study Brief:
Protocol Section:
NCT03648632