Organ preservation in rectal adenocarcinoma: A phase II randomized controlled trial evaluating 3-year disease-free survival in patients with locally advanced rectal cancer treated with chemoradiation plus induction or consolidation chemotherapy, and total mesorectal excision or nonoperative management Journal Article

   

Authors:	Smith, J. J.; Chow, O.S.; Gollub, M. J.; Nash, G. M.; Temple, L. K.; Weiser, M. R.; Guillem, J. G.; Paty, P. B.; Avila, K.; Garcia-Aguilar, J.
Article Title:	Organ preservation in rectal adenocarcinoma: A phase II randomized controlled trial evaluating 3-year disease-free survival in patients with locally advanced rectal cancer treated with chemoradiation plus induction or consolidation chemotherapy, and total mesorectal excision or nonoperative management
Abstract:	Background: Treatment of patients with non-metastatic, locally advanced rectal cancer (LARC) includes pre-operative chemoradiation, total mesorectal excision (TME) and post-operative adjuvant chemotherapy. This trimodality treatment provides local tumor control in most patients; but almost one-third ultimately die from distant metastasis. Most survivors experience significant impairment in quality of life (QoL), due primarily to removal of the rectum. A current challenge lies in identifying patients who could safely undergo rectal preservation without sacrificing survival benefit and QoL. Methods/Design: This multi-institutional, phase II study investigates the efficacy of total neoadjuvant therapy (TNT) and selective non-operative management (NOM) in LARC. Patients with MRI-staged Stage II or III rectal cancer amenable to TME will be randomized to receive FOLFOX/CAPEOX: a) before induction neoadjuvant chemotherapy (INCT); or b) after consolidation neoadjuvant chemotherapy (CNCT), with 5-FU or capecitabine-based chemoradiation. Patients in both arms will be re-staged after completing all neoadjuvant therapy. Those with residual tumor at the primary site will undergo TME. Patients with clinical complete response (cCR) will receive non-operative management (NOM). NOM patients will be followed every 3months for 2years, and every 6months thereafter. TME patients will be followed according to NCCN guidelines. All will be followed for at least 5years from the date of surgery or-in patients treated with NOM-the last day of treatment. Discussion: The studies published thus far on the safety of NOM in LARC have compared survival between select groups of patients with a cCR after NOM, to patients with a pathologic complete response (pCR) after TME. The current study compares 3-year disease-free survival (DFS) in an entire population of patients with LARC, including those with cCR and those with pCR. We will compare the two arms of the study with respect to organ preservation at 3years, treatment compliance, adverse events and surgical complications. We will measure QoL in both groups. We will analyze molecular indications that may lead to more individually tailored treatments in the future. This will be the first NOM trial utilizing a regression schema for response assessment in a prospective fashion. Trial registration:NCT02008656 © 2015 Smith et al.
Keywords:	rectal cancer; pathologic complete response; chemoradiation therapy; clinical complete response; non-operative management; total mesorectal excision. total neoadjuvant therapy
Journal Title:	BMC Cancer
Volume:	15
ISSN:	1471-2407
Publisher:	Biomed Central Ltd
Date Published:	2015-10-23
Start Page:	767
Language:	English
DOI:	10.1186/s12885-015-1632-z
PROVIDER:	scopus
PMCID:	PMC4619249
PUBMED:	26497495
DOI/URL:	http://www.scopus.com/inward/record.url?eid=2-s2.0-84944907528&partnerID=40&md5=ac7b6c4de25833d47a1d7bf57cf0d8dd
Notes:	Export Date: 2 November 2015 -- Source: Scopus

https://synapse.mskcc.org/synapse/works/has_related_data_chk/82183