ABCSG P02 Details
A prospective randomized phase II trial of FOLFIRINOX alone versus FOLFIRINOX followed by radiochemotherapy in patients with locally advanced, primarily inoperable pancreatic cancer.
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To demonstrate that in patients suffering from a primarily inoperable LAPC, neoadjuvant chemotherapy followed by concurrent neoadjuvant radiochemotherapy is superior to neoadjuvant chemotherapy alone in terms of R0-resectability.
To demonstrate superior efficacy of neoadjuvant chemotherapy followed by concurrent neoadjuvant radiochemotherapy to neoadjuvant chemotherapy alone with respect to
- Tumor response according to RECIST criteria v.1.1
- Histo-pathological tumor response
- Progression free survival (PFS) and/or disease-free survival (DFS), and overall survival (OS)
- Toxicity according to NCI CTCAE v.4.0
- Perioperative complications
- Radiochemotherapy quality assurance (adherence to protocol)
- Informed consent signed prior to randomization and prior to any study specific procedure.
- Patients with histologically proven PDAC, classified as locally advanced, primarily inoperable disease; patients with suspicious peripancreatic lymph nodes at initial staging, accessible by surgery are included in the study.
- Tumor must have at least one diameter of 15 mm assessed with conventional imaging techniques (e.g. CT, MRI) and at least one diameter of 10 mm measured by contrast enhanced CT.
- Patients scheduled for neoadjuvant treatment by the interdisciplinary tumor board.
- Radiologically determinable disease defined by RECIST v.1.1 within 4 weeks prior to randomization.
- ECOG performance status ≤ 1 (see Appendix 4) or Karnofsky ≥ 70%.
- Adequate hematologic function, as follows (≤ 7d prior to randomization):
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (in case ANC is not routinely measured, alternatively relative neutrophil count > 50% is acceptable)
- White blood cell count (WBC) ≥ 3.0 x 109/L
- Platelet count ≥ 100 x 109/L
- Haemoglobin ≥ 9 g/dL
- Adequate renal function, as follows (≤ 7d prior to randomization):
- Creatinine ≤ 1.5 x upper limit of normal (ULN) or GFR > 50 mL/min
- Adequate hepatic function, as follows (≤ 7d prior to randomization):
- Aspartate aminotransferase (ASAT) ≤ 5 x ULN
- Alanine aminotransferase (ALAT) ≤ 5 x ULN
- Total bilirubin ≤ 1.5 x ULN
- Any age ≥ 18 ≤ 75 years.
- Ability to comply with the protocol and attend follow up.
- Women of childbearing potential must have a negative pregnancy test done within 1 week prior to study drug administration. Women are not considered of childbearing potential in case that one of the following critera applies:
- after having undergone hysterectomy and/or bilateral ovarectomy and/or bilateral tubal ligation
- ≥ 60 years
- with FSH and E2 in the postmenopausal range (as defined per local guidelines)
- External biliary drain (Common bile duct stenting allowed).
- Major surgery within 4 weeks prior to start of study treatment.
- Any past or current history of other malignancies (except in situ carcinoma, non-metastatic non-melanomatous skin cancers) less than 2 years prior to randomization.
- Any radiological suspicion, or histological proof of distant metastases or extra-pancreatic disease other than regional lymph node enlargement at initial staging.
- Any chemo- or radiotherapy for PDAC prior to study inclusion.
- Concurrent or prior systemic antitumor therapy within the last 2 years.
- Active infection requiring systemic treatment or any uncontrolled infections < 14 days prior to randomization.
- Concurrent administration of other IMP during treatment phase.
- Concurrent participation in another clinical trial with the same primary endpoint.
- Pregnancy, lactation, women of childbearing potential not willing to use effective means of contraception until six months after completion of study treatment.
- Male patients not willing to use effective means of contraception until three months after completion of study treatment.
- Previous irradiation within the actual fields of planned radiotherapy.
- Any known hypersensitivity/allergic reaction to any of the components of study treatments.
- Any severe and/or uncontrolled medical conditions including but not limited to:
- Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 12 months prior to enrolment, serious uncontrolled cardiac arrhythmia
- Acute and/or chronic, active infectious disorders and non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by this study therapy
- Active disorders of skin and/or mucosa and/or ocular and/or GI disorders > grade 1 (according to NCI CTCAE v.4.0).
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, risk associated with study participation or IMP administration, or which, in the judgment of the investigator, would make the patient inappropriate for study participation