Randomized Multicenter Phase II/III Study With Adjuvant G... | NCT02172976

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Jan 2020Actual

Completion Date

May 2020Actual

First Submitted Date

May 23, 2014

First Submission Date that Met QC Criteria

Jun 23, 2014

First Posted Date

Jun 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2020

Last Update Posted Date

Sep 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this multicenter study, patients with resectable pancreatic carcinoma will be treated with (a) surgery followed by 6 cycles gemcitabine or (b) 4-6 cycles FOLFIRINOX followed by surgery followed by 4-6 cycles FOLFIRINOX.

The overall survival between both therapies will be compared as well as other parameters.

Detailed Description

This is a phase II/III randomized multicenter study. Patients with resectable pancreatic carcinoma will be randomized in Arm A (surgery plus adjuvant gemcitabine, 6 cycles) or Arm B (4-6 cycles FOLFIRINOX neoadjuvant, 4-6 cycles FOLFIRINOX adjuvant).

Primary endpoint is the overall survival, secondary endpoints are progression-free survival, perioperative morbidity and mortality, rate of R0 resections, tolerability and feasibility of neoadjuvant FOLFIRINOX and others.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FOLFIRINOX	Experimental	Oxaliplatin 85mg/m², Irinotecan 180mg/m², 5-FU 400mg/m² Bolus i.v., 5-FU continuous Infusion 2400 mg/m² Natriumfolinate 400mg/m² 46h d1; qd15 6 cycles pre- and 6 cycles post- surgery	Drug: Oxaliplatin Drug: 5-Fluorouracil Drug: Irinotecan Drug: Natriumfolinate
Gemcitabine	Active Comparator	Gemcitabine 1000 mg/m² d1, d8, d15; qd 29; 6 cycles after surgery	Drug: Gemcitabine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gemcitabine	Drug		Gemcitabine
Oxaliplatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
median overall survival		From date of randomization until the date of death from any cause assessed up to 24 months

Secondary Outcomes

Measure	Description	Time Frame
median progression-free survival (PFS)		From date of randomization until the date of first documented progression / relapse or date of death from any cause, whichever came first, assessed up to 24 months
perioperative morbidity and mortality		30 days after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the pankreas. For histological confirmation, max. 3 tests are allowed. If no confirmation of carcinoma is possible, the patient can not be included into the study.
Radiological confirmation of a locally limited curativ resectable (primarily resectale or borderline situation) pankreas carcinoma without distant metastases.
no prior pancreas resection
no prior cytostatic chemotherapy
female and male patients > 18 and <=75 years using contraception
ECOG ≤ 1
medical resectability
granulocytes > 1.500/µl
thrombocytes > 100.000/µl
hemoglobin ≥ 8,0 g/dl
serumcreatinine ≤ 1.5x of normal value or Creatinine-Clearance > 50 ml/min
written informed consent

Exclusion Criteria:

Endocrine pancreas carcinoma
locally advanced inoperable stages: non-resectable infiltration of V. porta or longway infiltration of A. mesenterica superior or infiltration of Truncus coeliacus.
distant metastases
Relapse
prior radiotherapy of measurable lesions
peritonealcarcinosis
malignant secondary disease, dated back < 5 years (exeption: in-situ-carcinoma of the cervix, adequately treated skin basal cell carcinoma)
contraindication for operative resection
ECOG ≥ 2
severe liver dysfunction (AST/ALT>3,5xULN, AP>6xULN)
Transhepatic drainage
active CHD (symptoms present), cardiomyopathy or heart insufficiency stage III-IV according to NYHA and EF < 45%
severe non-surgical accompanying diseases or acute infection
chronic diarrhea
chronic inflammable gastro-intestinal disease
peripheral polyneuropathy > NCI grade II
pregnancy or lactation
hypersensibility or contraindication for Gemcitabine, Oxaliplatin, Natriumfolinate, Irinotecan or 5-Fluorouracil
participation in another interventional trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms
D004066	Digestive System Diseases
D010182	Pancreatic Diseases
D004700	Endocrine System Diseases

ID	Term
D000093542	Gemcitabine
D000077150	Oxaliplatin
D005472	Fluorouracil
D000077146	Irinotecan

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D056831	Coordination Complexes
D009930	Organic Chemicals
D014498	Uracil
D011744	Pyrimidinones
D002166	Camptothecin
D000470	Alkaloids