Induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as neoadjuvant treatment for locally recurrent rectal cancer: the PelvEx II study
Date
2021
Authors
Voogt, E.
Burger, P.
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Journal article
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BJS Open, 2021; 47(2):e22-e23
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PelvEx Collaborative: E. L. K. Voogt ... H. M. Kroon ... et al.
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Abstract
Background: A resection with clear resection margins (R0 resection) is the single most important prognostic factor for overall and local recurrence free survival in patients with locally recurrent rectal cancer (LRRC). However, despite the use of neoadjuvant chemo(re)irradiation, an R0 resection is achieved in only ±60% of patients. Induction chemotherapy in addition to neoadjuvant chemoradiotherapy is increasingly being used, as this combination may increase the R0 resection rate. Still, evidence for any beneficial effect of induction chemotherapy is lacking. Materials and Methods: We have set up an international, multicentre, open-label, phase III, parallel arms study that randomises patients in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm). Eligible patients are adults diagnosed with resectable LRRC after previous partial or total mesorectal resection, with a good performance status, without synchronous distant metastases, without recent chemo- and/or radiotherapy, or any contraindications for the planned study interventions. Induction chemotherapy consists of three 3-weekly cycles capecitabine with oxaliplatin (CAPOX) or four two-weekly cycles of 5-fluorouracil with leucovorin and oxaliplatin (FOLFOX) or 5-fluorouracil with leucovorin and irinotecan (FOLFIRI) (physician’s discretion). In case of stable or responsive disease, treatment is continued with one cycle CAPOX or two cycles FOLFOX/FOLFIRI. Radiotherapy dose is 25x2.0Gy or 28x1.8Gy in radiotherapy-naïve patients and 15x2.0Gy in previously irradiated patients. Concomitant chemotherapy agent is capecitabine 825mg/m2 twice daily on radiotherapy days. We hypothesized a 15% increase in the R0 resection rate in the experimental arm. With a 5% two-sided significance level, a power of 80% and a drop-out of 5%, a total of 364 patients is required. Results: The primary outcome is the rate of resections with clear margins (R0 resection). Secondary outcomes are local recurrence free survival, metastasis free survival, progression free survival, disease free, overall survival, radiological and pathological response, toxicity and compliance of neoadjuvant treatment, surgical morbidity, health-related costs and quality of life. Conclusions: This is the first randomised study that compares induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery with neoadjuvant chemoradiotherapy and surgery in patients with locally recurrent rectal cancer with the aim to improve surgical and oncological outcomes. The first inclusion is anticipated October 2020.
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© 2020 Published by Elsevier Ltd.