Preoperative treatment with mFOLFIRINOX (or Gem-Nab-P) +/- isotoxic high-dose Stereotactic Body Radiation Therapy (iHD-SBRT) for borderline resectable pancreatic adenocarcinoma: a randomised comparative multicentre phase II study (STEREOPAC)

Conditions

Pancreatic adenocarcinoma

Brief summary

Residual tumour (R)0 resection, Disease-free-survival

Detailed description

Resection rate, Locoregional failure free interval, Distant metastases free interval, Toxicity, Incidence of adverse events, Complete feasibility of the therapeutic sequence, Overall survival, Pathologic complete/major response rate (pCR), Quality of life assessment, Postoperative complications rate, Technical and quality success rate of EUS-delivered fiducials

Christelle Bouchart, Julie Navez, Ivan Borbath, Karen Geboes, Timon Vandamme et al. (10 authors)

Cancer Research2024-01-16

10.1158/1538-7445.panca2023-a001

Preoperative treatment with mFOLFIRINOX or Gemcitabine/Nab-paclitaxel +/- isotoxic high-dose stereotactic body Radiation Therapy (iHD-SBRT) for borderline resectable pancreatic adenocarcinoma (the STEREOPAC trial): study protocol for a randomised comparative multicenter phase II trial.

Bouchart C, Navez J, Borbath I, Geboes K, Vandamme T, Closset J, Moretti L, Demetter P, Paesmans M, Van Laethem JL.

2023-09-217 citations

10.1186/s12885-023-11327-x

Interventions

DRUGFLUOROURACIL

DRUGGemcitabine AB 40 mg/ml

DRUGconcentraat voor oplossing voor infusie

DRUGFolinate EG 100mg/10ml oplossing voor injectie

DRUGIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DRUGGEMCITABINE

DRUGCALCIUM FOLINATE

DRUGOxaliplatin Accord Healthcare 5 mg/ml concentraat voor oplossing voor infusie

DRUGIrinotecan AB 20 mg/ml solution à diluer pour perfusion

DRUGPACLITAXEL

DRUGIRINOTECAN

DRUGFluorouracil Accord Healthcare 50 mg/ml oplossing voor injectie of infusie

DRUGAbraxane 5 mg/ml powder for dispersion for infusion.

DRUGOXALIPLATIN

DRUGFOLINIC ACID

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Residual tumour (R)0 resection, Disease-free-survival	—

Secondary

Measure	Time frame
Resection rate, Locoregional failure free interval, Distant metastases free interval, Toxicity, Incidence of adverse events, Complete feasibility of the therapeutic sequence, Overall survival, Pathologic complete/major response rate (pCR), Quality of life assessment, Postoperative complications rate, Technical and quality success rate of EUS-delivered fiducials	—

Countries

Belgium

Outcome results

None listed