Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant / Adjuvant FOLFIRINOX for Resectable Pancreas Carcinoma

NCT02172976 | Completed Phase 2 DMC

• 1 other identifier: NEPAFOX
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Resectable Prancreas Carcinoma

Keywords

pancreas cancer; neoadjuvant chemotherapy; Folfirinox; gemcitabine

Outcome Measures

Primary Outcomes (1)

• median overall survival

  From date of randomization until the date of death from any cause assessed up to 24 months

Secondary Outcomes (6)

• 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

• R0 resection rate

  2 months after surgery

• pathological complete remission

  at surgery

• adverse events (grade, number per patient) related to of G-CSF prophylaxis in the Folfirinox arm

  up to 40 weeks

Study Arms (2)

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

Gemcitabine DRUG

Gemcitabine

Oxaliplatin DRUG

FOLFIRINOX

5-Fluorouracil DRUG

FOLFIRINOX

Irinotecan DRUG

FOLFIRINOX

Natriumfolinate DRUG

FOLFIRINOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Krankenhaus Nordwest: lead

Study Sites (1)

Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany

Frankfurt, 60488, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Oxaliplatin; Fluorouracil; Irinotecan

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Camptothecin; Alkaloids

Study Officials

• Salah-Eddin Al-Batran, Prof.

  Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: June 24, 2014
• Study Start: November 1, 2014
• Primary Completion: January 1, 2020
• Study Completion: May 1, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)