Response prediction of neoadjuvant therapy in advanced pancreatic cancer (Neo-Response-Trial)

Recruiting

Conditions: C25
Malignant neoplasm of pancreas

Registration Number: DRKS00027840

Lead Sponsor: Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie, Universitätsklinikum Carl Gustav Carus der TU Dresden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 310

Inclusion Criteria

Initial inclusion criteria
- High-grade suspicion of pancreatic tumor on imaging.

Specific inclusion criteria after staging/histologic confirmation:
- Histologically confirmed, irresectable or borderline resectable pancreatic ductal adenocarcinoma (cT3-4 cNx M0) according to NCCN guidelines or the consensus of the International Study Group of Pancreatic Cancer.
- Exclusion of distant metastases by imaging of thorax/abdomen
- Planned implementation of neoadjuvant systemic therapy
- No contraindication to resection of the primarius (general operability given)
- No contraindications to performing neoadjuvant systemic therapy
- Female and male patients = 18 years of age.
- ECOG score = 2
- Patient is able and willing to give written informed consent and comply with the study protocol.

Exclusion Criteria

- Patients with recurrence (with or without previous incomplete/complete tumor resection)
- Patients with previous systemic tumor-specific therapy (such as chemotherapy or targeted therapy)
- Patients who are housed in a closed facility

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. correlation of response of a patient-individual cell culture model with surgical R0 resectability and histological regression grade. <br>2. correlation of exosomes in serum with surgical R0 resectability and histological regression grade. <br>3. correlation of KRAS mutation frequency in serum with surgical R0 resectability and histological regression grade. More than 90% of pancreatic cancers have KRAS mutation, so this marker is suitable for therapy monitoring.

Secondary Outcome Measures

Name	Time	Method
1. correlation of response in CT and PET-MRI performed after neoadjuvant therapy as part of routine clinical practice with surgical R0 resectability, histological regression grade, response of the patient-specific cell culture model, and detection of exosomes and KRAS mutation frequency in serum. <br>cell culture model, detection of exosomes, and KRAS mutation frequency in serum. <br>2. correlation of the above factors with disease-free and overall survival.