Combining high-dose stereotactic body radiation therapy and chemotherapy before surgery of borderline resectable pancreatic cancer

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)

Status
In preparation
 
Cancer types
  • Digestive cancer
Trial phase
2

Funding

€ 375,000
ACF donation
€ 950,000
Estimated trial cost

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: 

  • Prof. Dr. Jean-Luc Van Laethem, Hôpital Erasme – ULB, Brussels, Belgium 

Sponsor: 

  • Hôpital Erasme – ULB, Brussels, Belgium 

Other funding partners: 

  • Sponsor receives additional funding from Fondation Roi Baudouin and Les Amis de l’Institut Bordet.

Our role

Financial support + Scientific / Strategic input
Why we support this trial
Profit is a low priority in cancer treatment for the Anticancer Fund
Intervention has little or no commercial value
The Anticancer Fund wants to maximise the benefit for cancer patients
Expected survival benefit
The Anticancer Fund aims at no major hurdle for clinical implementation
No major hurdle for clinical implementation
The Anticancer Fund supports a trial that benefits a population with high unmet needs
Benefits a population with high unmet needs

Funding

€ 950,000
Estimated trial cost
€ 375,000
ACF donation
Questions about participation?
Mia Persoons
+32 2 555 30 16
Questions about this trial?
Anticancer Fund
studies [at] anticancerfund.org

References

More info: NCT05083247

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: July 2022