Combining high-dose stereotactic body radiation therapy and chemotherapy before surgery of borderline resectable pancreatic cancer
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)
Funding
Why this trial
Pancreatic adenocarcinoma is a very aggressive cancer with a high mortality rate. Surgery is the only treatment offering a chance for cure. However, less than 20% of the cases have immediately resectable cancers (resectable means the tumour can be removed by surgery) and about 50% have a potentially resectable cancer called "borderline resectable".
Even when surgery is possible, patients have a poor prognosis with an overall survival at 5 years of 20%. Therefore, surgery is combined with chemotherapy. In recent years, applying chemotherapy before rather than after the surgery has gained interest.
Here, this new study investigates a combination of chemo- and radiotherapy before surgery, in patients with borderline resectable pancreatic adenocarcinoma.
Why this intervention
Several recent studies have shown that chemoradiotherapy before surgery can be effective in patients with borderline resectable pancreatic adenocarcinoma. It seemed to improve the (chances of) surgery afterwards, and improved overall survival.
Isotoxic high-dose Stereotactic Body Radiation Therapy (iHD-SBRT) is a type of radiotherapy that delivers a high dose of radiation, while still showing acceptable toxicity levels. As seen in a recent study, this high dose of radiation is important to achieve the best results possible.
As for chemotherapy before surgery, mFOLFIRINOX (mFFX – a modified combination of oxaliplatin, irinotecan, leucovorin and fluorouracil) is often used in this patient population. mFFX has been shown to be safe and useful prior to surgery. It has become the preferred pre-surgery treatment, because it results in more successful surgeries as well as higher overall survival compared to other chemotherapies.
The combination of gemcitabine and nab-paclitaxel (Gem-Nab-P) is a valuable alternative for mFFX, according to a recent study.
Trial design
This is a phase II, prospective, randomised, interventional study for patients with borderline resectable pancreatic adenocarcinoma. Patients receive 8 cycles of mFFX with or without one week of iHD-SBRT, followed by surgery. In case of contraindications (reasons that make it inadvisable to take a particular drug or treatment) or intolerance to mFFX, Gem-Nab-P is used instead. A total of 256 patients will be enrolled and treated in ≥10 Belgian hospitals.
The primary objectives are to assess if this intervention will improve the surgical success rate and lengthen disease–free survival (the time that the patients survive without any signs or symptoms of pancreatic cancer).
Partners
Researchers:
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Prof. Dr. Jean-Luc Van Laethem, Hôpital Erasme – ULB, Brussels, Belgium
Sponsor:
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Hôpital Erasme – ULB, Brussels, Belgium
Other funding partners:
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Rising Tide Foundation for Clinical Cancer Research is partnering with the ACF to fund this trial.
- ACF is financially supported by the Funds Anhaive, A.B., Drieghe-Miller, and MaaikeLarsTrees, managed by the King Baudouin Foundation, and by Bart and Ann Verhaeghe.
Our role
Why we support this trial
Intervention has little or no commercial value
Expected survival benefit
No major hurdle for clinical implementation
Benefits a population with high unmet needs
Funding
References
More info: NCT05083247
Bouchart, C. et al. (2023) 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. BMC Cancer, Sep 21;23(1):891. doi: 10.1186/s12885-023-11327-x
Manderlier, M., et al. (2022) Isotoxic High-Dose Stereotactic Body Radiotherapy (iHD-SBRT) Versus Conventional Chemoradiotherapy for Localized Pancreatic Cancer: A Single Cancer Center Evaluation. Cancers (Basel), 14(23):5730. doi: 10.3390/cancers14235730
Bouchart, C., et al. (2020) PD-0420: Induction by mFOLFIRINOX followed by SIB-SBRT for the neoadjuvant treatment of pancreatic cancer. Radiat Oncol, 152:228
Bouchart, C., et al. (2020) Novel strategies using modern radiotherapy to improve pancreatic cancer outcomes: toward a new standard? Ther Adv Med Oncol, 12:1-26. doi: 10.1177/1758835920936093
Bouchart C., et al. (2021) Isotoxic high-dose stereotactic body radiotherapy integrated in a total multimodal neoadjuvant strategy for the treatment of localized pancreatic ductal adenocarcinoma. Ther Adv Med Oncol, 13:17588359211045860.
Katz MH., et al. (2020) Alliance A021501: Preoperative mFOLFIRINOX or mFOLFIRINOX plus hypofractionated radiation therapy (RT) for borderline resectable (BR) adenocarcinoma of the pancreas. JCO, 39:3_suppl377.
Jiang W., et al. (2019) Neoadjuvant stereotactic body radiation therapy for nonmetastatic pancreatic adenocarcinoma. Acta Oncol, 25: 1-8.
Authors: Liese Vandeborne (Research Manager), Kristine Beckers (Trial Manager)
Last updated: November 2023