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01-02-2012 | Colorectal Cancer

A Phase II Trial of Neoadjuvant Chemoradiation and Local Excision for T2N0 Rectal Cancer: Preliminary Results of the ACOSOG Z6041 Trial

Authors: Julio Garcia-Aguilar, MD, PhD, Qian Shi, PhD, Charles R. Thomas Jr., MD, Emily Chan, MD, PhD, Peter Cataldo, MD, Jorge Marcet, MD, David Medich, MD, Alessio Pigazzi, MD, Samuel Oommen, MD, Mitchell C. Posner, MD

Published in: Annals of Surgical Oncology | Issue 2/2012

Abstract

Purpose

We designed American College of Surgeons Oncology Group (ACOSOG) Z6041, a prospective, multicenter, single-arm, phase II trial to assess the efficacy and safety of neoadjuvant chemoradiation (CRT) and local excision (LE) for T2N0 rectal cancer. Here, we report tumor response, CRT-related toxicity, and perioperative complications (PCs).

Methods

Clinically staged T2N0 rectal cancer patients were treated with capecitabine and oxaliplatin during radiation followed by LE. Because of toxicity, capecitabine and radiation doses were reduced. LE was performed 6 weeks after CRT. Patients were evaluated for clinical and pathologic response. CRT-related complications and PCs were recorded.

Results

Ninety patients were accrued; 6 received nonprotocol treatment. The remaining 84 were 65% male; median age 63 years; 83% Eastern Cooperative Oncology Group performance score 0; 92% white; mean tumor size 2.9 cm; and average distance from anal verge 5.1 cm. Five patients were considered ineligible. Therapy was completed per protocol in 79 patients, but two patients did not undergo LE. Among 77 eligible patients who underwent LE, 34 patients achieved a pathologic complete response (44%) and 49 (64%) tumors were downstaged (ypT0–1), but 4 patients (5%) had ypT3 tumors. Five LE specimens contained lymph nodes; one T3 tumor had a positive node. All but one patient had negative margins. Thirty-three (39%) of 84 patients developed CRT-related grade ≥3 complications. Rectal pain was the most common PC.

Conclusions

CRT before LE for T2N0 tumors results in a high pathologic complete response rate and negative resection margins. However, complications during CRT and after LE are high. The true efficacy of this approach will ultimately be assessed by the long-term oncologic outcomes.

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Title: A Phase II Trial of Neoadjuvant Chemoradiation and Local Excision for T2N0 Rectal Cancer: Preliminary Results of the ACOSOG Z6041 Trial
Authors: Julio Garcia-Aguilar, MD, PhD
Qian Shi, PhD
Charles R. Thomas Jr., MD
Emily Chan, MD, PhD
Peter Cataldo, MD
Jorge Marcet, MD
David Medich, MD
Alessio Pigazzi, MD
Samuel Oommen, MD
Mitchell C. Posner, MD
Publication date: 01-02-2012
Publisher: Springer-Verlag
Published in: Annals of Surgical Oncology / Issue 2/2012
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI: https://doi.org/10.1245/s10434-011-1933-7

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

A Phase II Trial of Neoadjuvant Chemoradiation and Local Excision for T2N0 Rectal Cancer: Preliminary Results of the ACOSOG Z6041 Trial

Abstract

Purpose

Methods

Results

Conclusions

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

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