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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

1015 - Induction Chemotherapy Plus Chemoradiotherapy With or Without Aspirin in High Risk Rectal Cancer (ICAR)

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Topics

Cytotoxic Therapy

Tumour Site

Colon and Rectal Cancer

Presenters

Juliana Souza

Citation

Annals of Oncology (2018) 29 (suppl_8): viii150-viii204. 10.1093/annonc/mdy281

Authors

J.C.E.S.O.D. Souza1, R. Araujo2, M. Valadão2, C. Carrara3, M.Á. Barbosa4, R. Guimarães5, J. Carvalho5, G. Kovaleski6, I. Small7, A. Marins6, A.P. Victorino1, R. Gil1, J.P. Jesus2, L.H. de Araujo1, A.C. de Melo6

Author affiliations

  • 1 Oncology Department, INCA - Instituto Nacional de Cancer, 20231-050 - Rio de Janeiro/BR
  • 2 Surgery Department, INCA - Instituto Nacional de Cancer, 20231-050 - Rio de Janeiro/BR
  • 3 Radiologic Department, INCA - Instituto Nacional de Cancer, 20231-050 - Rio de Janeiro/BR
  • 4 Radiology Department, INCA - Instituto Nacional de Cancer, 20231-050 - Rio de Janeiro/BR
  • 5 Radiotherapy Department, INCA - Instituto Nacional de Cancer, 20231-050 - Rio de Janeiro/BR
  • 6 Clinical research Department, INCA - Instituto Nacional de Cancer, 20231-050 - Rio de Janeiro/BR
  • 7 Biostatiscs Department, INCA - Instituto Nacional de Cancer, 20231-050 - Rio de Janeiro/BR
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Resources

Abstract 1015

Background

Induction chemotherapy followed by chemoradiation is an attractive approach, with more favorable compliance and toxicity profiles. Furthermore, the benefit of aspirin in cancer of the colon and rectum is already known. Recently, it was described its potential activity during chemoradiotherapy. The aim is to evaluate the efficacy of total neoadjuvant treatment and the aspirin use during chemoradiotherapy for high-risk rectal cancer.

Trial design

Randomized trial to evaluate induction treatment with XELOX and Capecitabine-based chemoradiotherapy with or without aspirin in a high risk population selected by MRI. High-risk will be defined by presence of at least one of the following criteria on high-resolution thin-slice MRI: tumors within 1 mm of or beyond the mesorectal fascia; tumor extending 5 mm or more into perirectal fat; resectable cT4 tumors; lower third; nodal involvement; extramural vascular invasion. Primary objective is to evaluate the tumor downstaging after total neoadjuvant treatment with or without aspirin. All the patients enrolled in the study will receive XELOX every 21 days for four cycles, unless unacceptable toxicity or progression is detected. After this treatment, patients will be randomized to receive Capecitabine-based chemoradiotherapy with aspirin or placebo (Capecitabine 850 mg/m² 5 days per week combined with radiotherapy with total dose of 50.4 Gy in 28 days). Random assignment of treatment will be stratified by MRI tumour regression grade. After 8-10 weeks, they will be evaluated by MRI. Patients with complete clinical response will be managed with “watch and wait” approach. The sample size was calculated according to Simon's optimal two-stage design. Accordingly, 11 patients must be included in each group during the first stage. If 3 patients or fewer show downstaging, the trial will be stopped (interim efficacy analysis). Inclusion of patients will continue until 31 patients are included, in order to detect a difference of 26% or greater in downstaging. A treatment regimen will be considered effective if more than 10 patients of the total 31 show downstaging (final analysis), reaching 90% power with an alpha of 0.05 level of significance.

Clinical trial identification

NCT03170115.

Legal entity responsible for the study

INCA- Instituto Nacional de Câncer.

Funding

Has not received any funding.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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