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Int J Radiat Oncol Biol Phys. 2015 Sep 1;93(1):29-36. doi: 10.1016/j.ijrobp.2015.05.005. Epub 2015 May 14.

NRG Oncology Radiation Therapy Oncology Group 0822: A Phase 2 Study of Preoperative Chemoradiation Therapy Using Intensity Modulated Radiation Therapy in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer.

Author information

1
Massachusetts General Hospital, Boston, Massachusetts. Electronic address: tshong1@mgh.harvard.edu.
2
NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
3
University of Maryland School of Medicine, Baltimore, Maryland.
4
Sarah Cannon Research Institute, Nashville, Tennessee.
5
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.
6
North Main Radiation Oncology, Providence, Rhode Island.
7
London Regional Cancer Program/Western Ontario, London, Ontario.
8
Intermountain Medical Center, Salt Lake City, Utah.
9
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.
10
Piedmont Hospital, Atlanta, Georgia.
11
Main Line Community Clinical Oncology Program, Wynnewood, Pennsylvania.
12
University of Texas-MD Anderson Cancer Center, Houston, Texas.

Abstract

PURPOSE:

To evaluate the rate of gastrointestinal (GI) toxicity of neoadjuvant chemoradiation with capecitabine, oxaliplatin, and intensity modulated radiation therapy (IMRT) in cT3-4 rectal cancer.

METHODS AND MATERIALS:

Patients with localized, nonmetastatic T3 or T4 rectal cancer <12 cm from the anal verge were enrolled in a prospective, multi-institutional, single-arm study of preoperative chemoradiation. Patients received 45 Gy with IMRT in 25 fractions, followed by a 3-dimensional conformal boost of 5.4 Gy in 3 fractions with concurrent capecitabine/oxaliplatin (CAPOX). Surgery was performed 4 to 8 weeks after the completion of therapy. Patients were recommended to receive FOLFOX chemotherapy after surgery. The primary endpoint of the study was acute grade 2 to 5 GI toxicity. Seventy-one patients provided 80% probability to detect at least a 12% reduction in the specified GI toxicity with the treatment of CAPOX and IMRT, at a significance level of .10 (1-sided).

RESULTS:

Seventy-nine patients were accrued, of whom 68 were evaluable. Sixty-one patients (89.7%) had cT3 disease, and 37 (54.4%) had cN (+) disease. Postoperative chemotherapy was given to 42 of 68 patients. Fifty-eight patients had target contours drawn per protocol, 5 patients with acceptable variation, and 5 patients with unacceptable variations. Thirty-five patients (51.5%) experienced grade ≥ 2 GI toxicity, 12 patients (17.6%) experienced grade 3 or 4 diarrhea, and pCR was achieved in 10 patients (14.7%). With a median follow-up time of 3.98 years, the 4-year rate of locoregional failure was 7.4% (95% confidence interval [CI]: 1.0%-13.7%). The 4-year rates of OS and DFS were 82.9% (95% CI: 70.1%-90.6%) and 60.6% (95% CI: 47.5%-71.4%), respectively.

CONCLUSION:

The use of IMRT in neoadjuvant chemoradiation for rectal cancer did not reduce the rate of GI toxicity.

PMID:
26163334
PMCID:
PMC4540628
DOI:
10.1016/j.ijrobp.2015.05.005
[Indexed for MEDLINE]
Free PMC Article

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