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Title: 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

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,more » 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.« less
 [1] ;  [2] ;  [3] ;  [4] ;  [5] ;  [6] ;  [5] ;  [7] ;  [8] ;  [9] ;  [10] ;  [11] ;  [12]
  1. Massachusetts General Hospital, Boston, Massachusetts (United States)
  2. NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania (United States)
  3. University of Maryland School of Medicine, Baltimore, Maryland (United States)
  4. Sarah Cannon Research Institute, Nashville, Tennessee (United States)
  5. Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (United States)
  6. North Main Radiation Oncology, Providence, Rhode Island (United States)
  7. London Regional Cancer Program/Western Ontario, London, Ontario (Canada)
  8. Intermountain Medical Center, Salt Lake City, Utah (United States)
  9. Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey (United States)
  10. Piedmont Hospital, Atlanta, Georgia (United States)
  11. Main Line Community Clinical Oncology Program, Wynnewood, Pennsylvania (United States)
  12. University of Texas-MD Anderson Cancer Center, Houston, Texas (United States)
Publication Date:
OSTI Identifier:
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 93; Journal Issue: 1; Other Information: Copyright (c) 2015 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States