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Recruiting Phase 2

Preoperative mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose SBRT for Borderline Resectable Pancreatic Adenocarcinoma

NCT05083247 · tracked via the Priya Life Science Belgium tracker
Phase
Phase 2
Started
2023-03-24
Last updated
2023-05-23

Condition(s) studied

Pancreatic NeoplasmPancreatic AdenocarcinomaBorderline Resectable Pancreatic Adenocarcinoma

Investigational drug(s) / intervention(s)

mFOLFIRINOX or Gemcitabine nab-paclitaxelAll MFOLFIRINOX trials (27) →All Gemcitabine-nab-paclitaxel trials (8) →Isotoxic High-Dose (iHD)-SBRTSurgery

mFOLFIRINOX or Gemcitabine nab-paclitaxel: oxaliplatin IV, irinotecan IV, leucovorin IV and 5-FU IV OR Gemcitabine IV Nab paclitaxel

Isotoxic High-Dose (iHD)-SBRT: Radiation therapy

Surgery: Surgery

Study summary

Surgical resection is the only potentially curative treatment for patients with pancreatic cancer with the aim of curative R0 resection and related improvement of survival. As a standard, surgery is usually followed by adjuvant therapy that improves survival but neoadjuvant therapy (NAT) is a rapidly emerging concept that needs to be explored and validated in terms of therapeutic options in borderline resectable pancreatic tumors. In this setting, preoperative FFX seems to be feasible and can be prolonged by radiation therapy. However, the exact and best therapeutic sequence is not yet known and the additional role of adding isotoxic high-dose stereotactic body radiotherapy (iHD-SBRT) to chemotherapy requires validation in randomised trials. We propose to evaluate the impact and efficacy of adding iHD-SBRT to preoperative neoadjuvant mFFX or Gem-NabP in patients with borderline resectable pancreatic adenocarcinoma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: * Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinated process or body or tail. Diagnosis should be verified by local pathologist * cTNM stage: T1-4N0-2M0 * Confirmation of clinical and radiographic stage as borderline resectable (CT scan and/or MRI scan with contrast according to the NCCN criteria) by a multidisciplinary board, composed by a dedicated oncological surgeon, radiologist and GI oncologist) * Age \> 18 years old * No prior chemotherapy or radiation for pancreatic cancer * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * No grade ≥ 2 neuropathy * Laboratory parameters as follows: * Absolute neutrophil count (ANC) ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9 g/dL * Creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated GFR \>45 mL/min * Bilirubin ≤ 1.5 x ULN, including after adequate biliary stenting with metal stent (ideally 4 cm length) * Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5x ULN * CA 19.9 \< 2500 kU/l (baseline, prior to any therapy and absence of cholestasis) Exclusion Criteria: * Evidence of extrapancreatic disease on diagnostic imaging (CT, MRI or PET scan), histologically proven or at laparoscopy, including distal nodal involvement beyond the peripancreatic tissues (including non-regional lymph node involvement, ie: proven involvement of precaval lumbar lymphadenopathy(ies) and/or distant metastases * Locally advanced disease as defined by the NCCN criteria (version 2.2021) ie \> 180° arterial encasement (SMA and CA) unreconstructible venous encasement (SMV/PV) due to tumor involvement or occlusion of a long segment. * CA 19.9 \> 2500 kU/l (baseline and absence of cholestasis) * Contraindication of surgery (general) * Contraindications to receive FFX or gemcitabine-nab-Paclitaxel * History of radiotherapy of the upper abdomen * Prior treatment with oxaliplatin, irinotecan, fluoruouracil or capecitabin * Patient \< 18 years old * Major surgery within 4 weeks of study entry * Uncontrolled pre-existing disease including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina, social / psychiatric disorder that would limit compliance to treatment and good understanding of the informed consent form * Other concurrent anticancer therapies * Existence of another active neoplasia other than basal cell carcinoma of the skin, cervical carcinoma in situ or non-metastatic prostate cancer. Patients who have a history of neoplasia must have been in remission for more than 5 years to be included in the protocol * Pregnant or breastfeeding women; for women of childbearing potential only, a negative pregnancy test done \< 7 days prior to registration is required. Using of reliable contraception for at least 1 month before treatment is mandatory * Chronic concomitant treatment with strong inhibitors of cytochrome p450, family 3, subfamily a, polypeptide 4 gene (CYP3A4) is not allowed on this study; patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study Additional exclusion criteria before randomisation: * Progressive disease (RECIST or PETCT, including non locoregional nodal involvement and increase of CA 19.9 by 20%) after receiving 4 cycles of FFX (or G/NP), including shift chemotherapy in case of early progression. * CA 19.9 \> 1000 kU/l after neoadjuvant therapy. * Presence of unmanageable toxicity during the first part of neoadjuvant chemotherapy (first 4 cycles or 6 doses of FFX or G/NP, respectively. * Pancreatic tumour \> 7.0 cm in greatest axial dimension at the time of randomization * Massive invasion of the stomach or intestines and/or direct intestinal invasion of the mucosae visible at ultrasoundendoscopy * Active gastric or duodenal ulcer disease at the time of randomization. Tolerated in case of antecedent without active ulcer (confirmation by endoscopy before iHD-SBRT)

Primary outcome measure(s)

  • Disease free survival — From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 weeks
    Defined as time from randomisation to the first documentation of event where events considered are 1) disease progression, per RECIST, prior to surgery, 2) discovery of hepatic or peritoneal carcinomatosis during surgical exploration, 3) recurrent disease following R0-R1 surgery, or 4) death due to any cause.
  • R0 Resection rate — up to 12 months
    Defined as the proportion of eligible randomised patients in whom a R0 resection was achieved during surgery after neoadjuvant treatment with FOLFIRINOX +/- iHD-SBRT. R0 resection indicates a microscopically margin-negative resection (\>1 mm) from the inked margins (pancreatic transection, vascular and posterior circumferential resection margins).

Trial sites (10)

FacilityCityRegionStatus
Uza Antwerp Antwerp Belgium Recruiting
Hopital Erasme, HUB Brussels Belgium Recruiting
Jules Bordet Institute, HUB Brussels Belgium Recruiting
CHIREC Brussels Belgium Recruiting
Cliniques Universitaires St luc Brussels Belgium Recruiting
UZ Gent Ghent Belgium Not Yet Recruiting
AZ Groeninge Kortrijk Belgium Recruiting
Pôle Hospitalier Jolimont La Louvière Belgium Recruiting
Clinique Chc Montlégia Liège Belgium Recruiting
CHU Ambroise Paré Mons Belgium Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05083247 on ClinicalTrials.gov ↗ ← All trials in Belgium