Chemotherapy-based split stereotactic body radiation therapy for borderline resectable and locally advanced pancreatic cancer: study protocol of a prospective, single-arm phase II trial

Abstract

IntroductionThe question of how to administer adequate chemotherapy to synchronise stereotactic body radiation therapy (SBRT) treatment strategy to maximise the benefits of neoadjuvant therapy for the improved prognosis of patients with borderline resectable (BRPC) and locally advanced (LAPC) pancreatic cancer is a challenging and debatable issue. No studies have yet evaluated the efficacy of split-course SBRT as the neoadjuvant chemoradiotherapy regimen. We aimed to study whether neoadjuvant chemotherapy plus split-course SBRT results in better outcomes in BRPC and LAPC patients.Methods and analysisTreatment-naïve patients with radiographically confirmed BRPC or LAPC, supporting biopsy results and no severe comorbidities will be enrolled. They will be treated with nab-paclitaxel plus gemcitabine (nab-P+Gem) chemotherapy plus split-course SBRT, followed by an investigator’s choice of continuation of treatment with nab-P+Gem or surgery. nab-P+Gem chemotherapy will commence on day 1 for each of six cycles: nab-paclitaxel 125 mg/m2 intravenous infusion over approximately 30–45 min, followed by gemcitabine 1000 mg/m2 intravenous infusion over about 30 min on days 1 and 15 of each 28-day cycle. During the first and second cycles of chemotherapy, SBRT will be given as a single irradiation of 10 Gy four times (days 2 and 16 of each 28-day cycle). The primary endpoint is progression-free survival; while the secondary outcomes are the time to treatment failure, disease control rate, overall response rate, overall survival, R0 resection rate and incidence of adverse effects.Ethics and disseminationThe study protocol was approved by the Ethics Committee of Xiehe Affiliated Hospital of Fujian Medical University (No. 2019YF015-01). Results from our study will be disseminated in international peer-reviewed journals. All study procedures were developed in order to assure data protection and confidentiality.Trial registration numberNCT04289792.

Combining chemotherapy and tislelizumab with preoperative split-course hypofraction radiotherapy for locally advanced rectal cancer: study protocol of a prospective, single-arm, phase II trial

“…In most solid tumours, concurrent chemoradiotherapy tends to work better than chemoradiation in a sequential manner to manage localised or regionalised lesions and improve OS. 30 However, it also increases the toxicity and reduces treatment tolerance of patients, especially with full dose of chemotherapy. It is a regime for split-course radiotherapy intended to further reduce toxicity and increase the treatment tolerance of patients, with provision to extend the between-fraction intervals rather than irradiation on a daily basis.…”

“…In most solid tumours, concurrent chemoradiotherapy tends to work better than chemoradiation in a sequential manner to manage localised or regionalised lesions and improve OS 30. However, it also increases the toxicity and reduces treatment tolerance of patients, especially with full dose of chemotherapy.…”

Uniform expansion vs. non-uniform expansion of gross tumor volume based on recurrence patterns to form planning target volume of stereotactic body radiation therapy for locally advanced pancreatic cancer: protocol of a randomized phase II study

“…Whether stereotactic radiotherapy can provide clinical bene ts in the treatment of pancreatic cancer depends on prescription doses and accurate target delineations. Most previous studies have investigated appropriate doses and correlations between doses and outcomes regarding SBRT for pancreatic cancer [17,18,19,20]. On the contrary, there were limited studies on target delineations, and lack of the guidelines or consensus about it.…”

GSK484, an inhibitor of peptidyl arginine deiminase 4, increases the radiosensitivity of colorectal cancer and inhibits neutrophil extracellular traps

“…Radiotherapy is an important treatment for CRC and has become a standard treatment regimen for stage II and III CRC. Existing clinical trials show that, compared with surgical treatment or preoperative radiotherapy alone, postoperative radiotherapy exhibits significant advantages in tumor downstaging, pathological response rate and progression‐free survival 2,3 . However, the radioresistance of CRC may facilitate tumor recurrence and a poor prognosis for patients.…”