EUCTR2013-004796-12-DE
Active, not recruiting
Phase 1
Prospective Randomized Multicenter Phase II Trial toInvestigate Intensified Neoadjuvant Chemotherapy inLocally Advanced Pancreatic Cancer - NEOLAP
Conditionsocally advanced pancreatic cancerMedDRA version: 21.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsAbraxane
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ocally advanced pancreatic cancer
- Sponsor
- AIO-Studien-gGmbH
- Enrollment
- 168
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Adult patients \= 18 years and \= 75 years of age
- •\- Histologic or cytologic proven ductal adenocarcinoma of the
- •pancreas (histologic confirmation of diagnosis is preferred)
- •\- No distant metastases
- •\- De novo, treatment\-nai¨ve unresectable or borderline resectable
- •LAPC; evaluation of unresectable and borderline resectable status
- •based on recommendations in NCCN\- Clinical Practice Guidelines in Oncology
- •pancreatic adenocarcinoma” version 1\.2015\. Applicable
- •criterion/criteria have to be indicated.
- •\- Eastern Cooperative Oncology Group (ECOG) performance status
Exclusion Criteria
- •\- Evidence of distant metastases. In case of radiological suspicion of
- •peritoneal carcinomatosis or ascites histological or cytological
- •verification is required e.g. by means of exploratory laparoscopy
- •\- Local relapse of the pancreatic adenocarcinoma prior treated with
- •surgical resection
- •\- Any previous treatment of the pancreatic carcinoma
- •\- Contraindication for pancreas resection
- •\- Larger surgical interventions within 4 weeks before study
- •enrolment and/or diagnostic laparotomy with or without
- •gastroenterostomy and with or without biliodigestive anastomosis
Outcomes
Primary Outcomes
Not specified
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