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

  • Colorectal Cancer
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

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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Acknowledgment

The authors thank Nicola Solomon, PhD, for assistance in writing and editing the article. This work was supported by funding from the US National Cancer Institute (NCI) to the American College of Surgeons Oncology Group (ACOSOG); grant U10 CA76001; and Sanofi-Aventis.

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Authors and Affiliations

  1. Department of Surgery, City of Hope, Duarte, USA

    Julio Garcia-Aguilar MD, PhD & Alessio Pigazzi MD

  2. Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, USA

    Qian Shi PhD

  3. Knight Cancer Institute, Oregon Health and Science University, Portland, USA

    Charles R. Thomas Jr. MD

  4. Vanderbilt University Medical Center, Nashville, USA

    Emily Chan MD, PhD

  5. Department of Surgery, University of Vermont, Burlington, USA

    Peter Cataldo MD

  6. Tampa General Hospital, Tampa, USA

    Jorge Marcet MD

  7. Allegheny Cancer Center, Pittsburgh, USA

    David Medich MD

  8. John Muir Hospital, Concord, USA

    Samuel Oommen MD

  9. University of Chicago Medical Center, Chicago, USA

    Mitchell C. Posner MD

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  1. Julio Garcia-Aguilar MD, PhD
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  2. Qian Shi PhD
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Correspondence to Julio Garcia-Aguilar MD, PhD.

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Garcia-Aguilar, J., Shi, Q., Thomas, C.R. et al. A Phase II Trial of Neoadjuvant Chemoradiation and Local Excision for T2N0 Rectal Cancer: Preliminary Results of the ACOSOG Z6041 Trial. Ann Surg Oncol 19, 384–391 (2012). https://doi.org/10.1245/s10434-011-1933-7

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  • DOI: https://doi.org/10.1245/s10434-011-1933-7

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