Radiotherapy & Oncology
Volume 102, Issue 1 , Pages 4-9 , January 2012

Preoperative concomitant boost intensity-modulated radiotherapy with oral capecitabine in locally advanced mid-low rectal cancer: A phase II trial

  • Jin-luan Li

      Affiliations

    • Department of Radiation Oncology, Beijing Cancer Hospital and Institute, People’s Republic of China
    • These authors contributed equally to this article.
  • ,
  • Jia-fu Ji

      Affiliations

    • Department of Gastrointestinal Surgery, Beijing Cancer Hospital and Institute, People’s Republic of China
    • These authors contributed equally to this article.
  • ,
  • Yong Cai

      Affiliations

    • Department of Radiation Oncology, Beijing Cancer Hospital and Institute, People’s Republic of China
    • Corresponding Author InformationCorresponding author. Address: Department of Radiation Oncology, Peking University School of Oncology, Peking University Cancer Hospital, Beijing Cancer Hospital and Institute, 52 Fucheng Rd., Haidian District, Beijing 100142, People’s Republic of China.
  • ,
  • Xiao-fan Li

      Affiliations

    • Department of Radiation Oncology, Beijing Cancer Hospital and Institute, People’s Republic of China
  • ,
  • Yong-heng Li

      Affiliations

    • Department of Radiation Oncology, Beijing Cancer Hospital and Institute, People’s Republic of China
  • ,
  • Hao Wu

      Affiliations

    • Department of Radiation Oncology, Beijing Cancer Hospital and Institute, People’s Republic of China
  • ,
  • Bo Xu

      Affiliations

    • Department of Radiation Oncology, Beijing Cancer Hospital and Institute, People’s Republic of China
  • ,
  • Fang-yuan Dou

      Affiliations

    • Department of Pathology, Beijing Cancer Hospital and Institute, People’s Republic of China
  • ,
  • Zi-yu Li

      Affiliations

    • Department of Gastrointestinal Surgery, Beijing Cancer Hospital and Institute, People’s Republic of China
  • ,
  • Zhao-de Bu

      Affiliations

    • Department of Gastrointestinal Surgery, Beijing Cancer Hospital and Institute, People’s Republic of China
  • ,
  • Ai-wen Wu

      Affiliations

    • Department of Gastrointestinal Surgery, Beijing Cancer Hospital and Institute, People’s Republic of China
  • ,
  • Ivan W.K. Tham

      Affiliations

    • Department of Radiation Oncology, National University Cancer Institute, Singapore

Received 20 March 2011 ,Revised 29 July 2011 ,Accepted 29 July 2011.

References 

  1. Harnsberger JR, Vernava VM, Longo WE. Radical abdominopelvic lymphadenectomy: historic perspective and current role in the surgical management of rectal cancer. Dis Colon Rectum. 1994;37:73–87
  2. Kapiteijn E, Marijnen CA, Colenbrander AC, et al. Local recurrence in patients with rectal cancer diagnosed between 1988 and 1992: a population-based study in the west Netherlands. Eur J Surg Oncol. 1998;24:528–535
  3. Havenga K, Enker WE, Norstein J, et al. Improved survival and local control after total mesorectal excision or D3 lymphadenectomy in the treatment of primary rectal cancer: an international analysis of 1411 patients. Eur J Surg Oncol. 1999;25:368–374
  4. Heald RJ, Moran BJ, Ryall RD, Sexton R, MacFarlane JK. Rectal cancer: the Basingstoke experience of total mesorectal excision, 1978–1997. Arch Surg. 1998;133:894–899
  5. Kapiteijn E, Putter H, van de Velde CJ, et al. Cooperative investigators of the Dutch ColoRectal Cancer Group. Impact of the introduction and training of total mesorectal excision on recurrence and survival in rectal cancer in The Netherlands. Br J Surg. 2002;89:1142–1149
  6. Peeters KC, Marijnen CA, Nagtegaal ID, et al. The TME trial after a median follow-up of 6 years: increased local control but no survival benefit in irradiated patients with resectable rectal carcinoma. Ann Surg. 2007;246:693–701
  7. Bosset JF, Collette L, Calais G, et al. Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med. 2006;355:1114–1123
  8. Gérard JP, Conroy T, Bonnetain F, et al. Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3–4 rectal cancers: results of FFCD 9203. J Clin Oncol. 2006;24:4620–4625
  9. Capirci C, Valentini V, Cionini L, et al. Prognostic value of pathologic complete response after neoadjuvant therapy in locally advanced rectal cancer: long-term analysis of 566 ypCR patients. Int J Radiat Oncol Biol Phys. 2008;72:99–107
  10. Saif MW, Hashmi S, Zelterman D, Almhanna K, Kim R. Capecitabine vs continuous infusion 5-FU in neoadjuvant treatment of rectal cancer. A retrospective review. Int J Colorectal Dis. 2008;23:139–145
  11. Kim DY, Jung KH, Kim TH, et al. Comparison of 5-fluorouracil/leucovorin and capecitabine in preoperative chemoradiotherapy for locally advanced rectal cancer. Int J Radiat Oncol Biol Phys. 2007;67:378–384
  12. Velenik V, Oblak I, Anderluh F. Long-term results from a randomized phase II trial of neoadjuvant combined-modality therapy for locally advanced rectal cancer. Radiat Oncol. 2010;5:88
  13. Ballonoff A, Kavanagh B, McCarter M, et al. Preoperative capecitabine and accelerated intensity-modulated radiotherapy in locally advanced rectal cancer: a phase II trial. Am J Clin Oncol. 2008;31:264–270
  14. Roels S, Duthoy W, Haustermans K, et al. Definition and delineation of the clinical target volume for rectal cancer. Int J Radiat Oncol Biol Phys. 2006;65:1129–1142
  15. Gallagher MJ, Brereton HD, Rostock RA, et al. A prospective study of treatment techniques to minimize the volume of pelvic small bowel with reduction of acute and late effects associated with pelvic irradiation. Int J Radiat Oncol Biol Phys. 1986;12:1565–1573
  16. Baglan KL, Frazier RC, Yan D, Huang RR, Martinez AA, Robertson JM. The dose–volume relationship of acute small bowel toxicity from concurrent 5-FU-based chemotherapy and radiation therapy for rectal cancer. Int J Radiat Oncol Biol Phys. 2002;52:176–183
  17. Dworak O, Keilholz L, Hoffmann A. Pathological features of rectal cancer after preoperative radiochemotherapy. Int J Colorectal Dis. 1997;12:19–23
  18. Rödel C, Martus P, Papadoupolos T, et al. Prognostic significance of tumor regression after preoperative chemoradiotherapy for rectal cancer. J Clin Oncol. 2005;23:8688–8696
  19. A’Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med. 2001;20:859–866
  20. Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics. 1982;38:143–151
  21. Valentini V, Beets-Tan R, Borras JM, et al. Evidence and research in rectal cancer. Radiother Oncol. 2008;87:449–474
  22. Freedman GM, Meropol NJ, Sigurdson ER, et al. Phase I trial of preoperative hypofractionated intensity-modulated radiotherapy with incorporated boost and oral capecitabine in locally advanced rectal cancer. Int J Radiat Oncol Biol Phys. 2007;67:1389–1393
  23. Aschele C, Pinto C, Cordio S, et al. Preoperative fluorouracil (FU)-based chemoradiation with, without weekly oxaliplatin in locally advanced rectal cancer: pathologic response analysis of the Studio Terapia Adiuvante Retto (STAR)-01 randomized phase III trial. J Clin Oncol. 2009;27:170s;[suppl; abstr CRA4008]
  24. Rödel C, Grabenbauer GG, Papadopoulos T, Hohenberger W, Schmoll HJ, Sauer R. Phase I/II trial of capecitabine, oxaliplatin, and radiation for rectal cancer. J Clin Oncol. 2003;21:3098–3104
  25. Gérard JP, Azria D, Gourgou-Bourgade S, et al. Comparison of two neoadjuvant chemoradiotherapy regimens for locally advanced rectal cancer: results of the phase III trial ACCORD 12/0405-Prodige 2. J Clin Oncol. 2010;28:1638–1644
  26. Chua YJ, Barbachano Y, Cunningham D, et al. Neoadjuvant capecitabine and oxaliplatin before chemoradiotherapy and total mesorectal excision in MRI-defined poor-risk rectal cancer: a phase 2 trial. Lancet Oncol. 2010;11:241–248
  27. Fowler JF. The linear-quadratic formula and progress in fractionated radiotherapy. Br J Radiol. 1989;62:679–694
  28. Jones B, Dale RG. Mathematical models of tumour and normal tissue response. Acta Oncol. 1999;38:883–893
  29. Coucke PA, Notter M, Stamm B, et al. Preoperative hyper-fractionated accelerated radiotherapy (HART) in locally advanced rectal cancer (LARC) immediately followed by surgery. A prospective phase II trial. Radiother Oncol. 2006;79:52–58
  30. Bujko K, Nowacki MP, Nasierowska-Guttmejer A, et al. Sphincter preservation following preoperative radiotherapy for rectal cancer: report of a randomised trial comparing short-term radiotherapy vs. conventionally fractionated radiochemotherapy. Radiother Oncol. 2004;72:15–24
  31. Gerard JP. The Estro Regaud Lecture. Radiotherapy in the conservative treatment of rectal cancer. Evidence-based medicine and opinion. Radiother Oncol. 2005;74:227–233
  32. De Paoli A, Chiara S, Luppi G, et al. Capecitabine in combination with preoperative radiation therapy in locally advanced, resectable, rectal cancer: a multicentric phase II study. Ann Oncol. 2006;17:246–251
  33. Sauer R, Becker H, Hohenberger W, et al. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004;351:1731–1740
  34. Debucquoy A, Roels S, Goethals L, et al. Double blind randomized phase II study with radiation+5-fluorouracil±celecoxib for resectable rectal cancer. Radiother Oncol. 2009;93:273–278

 This trial is registered with chictr.org. Trial registry number: ChiCTR-TNC-10001094.

PII: S0167-8140(11)00408-7

doi: 10.1016/j.radonc.2011.07.030

Radiotherapy & Oncology
Volume 102, Issue 1 , Pages 4-9 , January 2012