Clinical trial NCT02172976: Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant / Adjuvant FOLFIRINOX for Resectable Pancreas Carcinoma
Official title: Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Resectable Prancreas Carcinoma
Keywords: pancreas cancer
neoadjuvant chemotherapy
Folfirinox
gemcitabine
Lead sponsor: Krankenhaus Nordwest
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Radiological confirmation of a locally limited curativ resectable (primarily resectale or borderline situation) pankreas carcinoma without distant metastases.
3. no prior pancreas resection
4. no prior cytostatic chemotherapy
5. female and male patients \> 18 and \<=75 years using contraception
6. ECOG ≤ 1
7. medical resectability
8. granulocytes \> 1.500/µl
9. thrombocytes \> 100.000/µl
10. hemoglobin ≥ 8,0 g/dl
11. serumcreatinine ≤ 1.5x of normal value or Creatinine-Clearance \> 50 ml/min
12. written informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: median overall survival
timeFrame: From date of randomization until the date of death from any cause assessed up to 24 months
Secondary outcomes:
measure: median progression-free survival (PFS)
timeFrame: 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
measure: perioperative morbidity and mortality
timeFrame: 30 days after surgery
measure: R0 resection rate
timeFrame: 2 months after surgery
measure: pathological complete remission
timeFrame: at surgery
measure: adverse events (grade, number per patient) related to of G-CSF prophylaxis in the Folfirinox arm
timeFrame: up to 40 weeks
measure: prevalence of iron deficiency
timeFrame: baseline, d1 of every cycle, end of treatment
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany
Study officials:
affiliation: Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany
name: Salah-Eddin Al-Batran, Prof.
role: PRINCIPAL_INVESTIGATOR
References: