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BMC Cancer
Published in: BMC Cancer 1/2013

Open Access 01-12-2013 | Study protocol

Short-course radiotherapy followed by neo-adjuvant chemotherapy in locally advanced rectal cancer – the RAPIDO trial

Authors: Per J Nilsson, Boudewijn van Etten, Geke AP Hospers, Lars Påhlman, Cornelis JH van de Velde, Regina GH Beets-Tan, Lennart Blomqvist, Jannet C Beukema, Ellen Kapiteijn, Corrie AM Marijnen, Iris D Nagtegaal, Theo Wiggers, Bengt Glimelius

Published in: BMC Cancer | Issue 1/2013

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Abstract

Background

Current standard for most of the locally advanced rectal cancers is preoperative chemoradiotherapy, and, variably per institution, postoperative adjuvant chemotherapy. Short-course preoperative radiation with delayed surgery has been shown to induce tumour down-staging in both randomized and observational studies. The concept of neo-adjuvant chemotherapy has been proven successful in gastric cancer, hepatic metastases from colorectal cancer and is currently tested in primary colon cancer.

Methods and design

Patients with rectal cancer with high risk features for local or systemic failure on magnetic resonance imaging are randomized to either a standard arm or an experimental arm. The standard arm consists of chemoradiation (1.8 Gy x 25 or 2 Gy x 25 with capecitabine) preoperatively, followed by selective postoperative adjuvant chemotherapy. Postoperative chemotherapy is optional and may be omitted by participating institutions. The experimental arm includes short-course radiotherapy (5 Gy x 5) followed by full-dose chemotherapy (capecitabine and oxaliplatin) in 6 cycles before surgery. In the experimental arm, no postoperative chemotherapy is prescribed. Surgery is performed according to TME principles in both study arms. The hypothesis is that short-course radiotherapy with neo-adjuvant chemotherapy increases disease-free and overall survival without compromising local control. Primary end-point is disease-free survival at 3 years. Secondary endpoints include overall survival, local control, toxicity profile, and treatment completion rate, rate of pathological complete response and microscopically radical resection, and quality of life.

Discussion

Following the advances in rectal cancer management, increased focus on survival rather than only on local control is now justified. In an experimental arm, short-course radiotherapy is combined with full-dose chemotherapy preoperatively, an alternative that offers advantages compared to concomitant chemoradiotherapy with or without postoperative chemotherapy. In a multi-centre setting this regimen is compared to current standard with the aim of improving survival for patients with locally advanced rectal cancer.

Trial registration

ClinicalTrials.gov NCT01558921
Appendix
Available only for authorised users
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Metadata
Title
Short-course radiotherapy followed by neo-adjuvant chemotherapy in locally advanced rectal cancer – the RAPIDO trial
Authors
Per J Nilsson
Boudewijn van Etten
Geke AP Hospers
Lars Påhlman
Cornelis JH van de Velde
Regina GH Beets-Tan
Lennart Blomqvist
Jannet C Beukema
Ellen Kapiteijn
Corrie AM Marijnen
Iris D Nagtegaal
Theo Wiggers
Bengt Glimelius
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2013
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/1471-2407-13-279

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