Lapatinib-capecitabine versus capecitabine alone as radiosensitizers in RAS wild-type resectable rectal cancer, an adaptive randomized phase II trial (LaRRC trial): study protocol for a randomized controlled trial

• Type: Article in International Scientific Journal
• Date: 2016

Authors

Sousa, N (Author) Other; Sousa, O (Author) Other; Santos, LL (Author) Other; henrique, rmf (Author) ICBAS; Manuel R Teixeira (Author) ICBAS; Mario Dinis Ribeiro (Author) FMUP; Teixeira Pinto, A (Author) Other

Journal

Title: Trials

Vol. 17

ISSN: 1745-6215

Publisher: Springer Nature

Indexing

ISI Web of Knowledge - 2 Citations

Scopus - 2 Citations

Other information

Authenticus ID: P-00K-X85

DOI: 10.1186/s13063-016-1583-y

Abstract (EN): Background: Preoperative radiochemotherapy followed by surgical removal of the rectum with total mesorectum excision is the preferred treatment option for stages II and III rectal cancer. However, development of metastatic disease is the main cause of death for these patients with 5-year disease-free survival rates of 56 %. Anti-epidermal growth factor receptor (EGFR) targeted therapy is effective in metastatic rectal cancer, and human epidermal growth factor receptor 2 (HER-2) signaling may mediate resistance to EGFR inhibitors. Moreover, preclinical data support a synergistic effect of EGFR inhibition with radiation therapy. Methods/design: This Bayesian phase II trial with adaptive randomization was designed to assess the efficacy of adding lapatinib, a dual inhibitor of EGFR and HER-2, to standard radiochemotherapy with capecitabine in stages II and III rectal cancer. Discussion: The results of this trial will provide evidence of the feasibility and efficacy of the combination of lapatinib-capecitabine as radiosensitizers and explore potential predictive biomarkers for response to this novel neoadjuvant approach to resectable rectal cancer.

Language: English

Type (Professor's evaluation): Scientific

No. of pages: 13