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Promising Results of a Cooperative Group Phase II Trial of Preoperative Chemoradiation for Locally Advanced Rectal Cancer (TROG 9801)

  • Original Contribution
  • Published:
Diseases of the Colon & Rectum

PURPOSE

This article reports the overall survival, failure-free survival, local failure, and late radiation toxicity of a phase II trial of preoperative radiotherapy with continuous infusion 5-fluorouracil for rectal cancer after a minimum 3.5 years of follow-up.

METHODS

Eligible patients were those with newly diagnosed localized adenocarcinoma of the rectum, within 12 cm of the anal verge, staged T3–T4 and deemed suitable for curative resection. Radiotherapy (50.4 Gy in 28 fractions in five weeks and three days) was given with continuous infusion 5-fluorouracil throughout the course of radiotherapy.

RESULTS

A total of 82 patients were accrued in 13 months. The median follow-up time was 4.1 (range, 2.3–4.5) years. There were 55 males (67 percent) and the median age was 59 (range, 27–87) years. Patients were staged pretreatment as T3 (89 percent) and resectable T4 (11 percent). Endorectal ultrasound was performed in 70 percent and magnetic resonance imaging in another 5 percent. The four-year overall and failure-free survival rates were 82 percent (95 percent CI: 72–89) and 69 percent (95 percent CI: 58–78), respectively. The cumulative incidence of local failure at four years was 3.9 percent (95 percent CI: 1.3–11). Risk of failures, local and distant, has not reached a plateau phase.

CONCLUSION

This regimen can be delivered safely and without leading to a significant increase in late toxicity. It provides excellent local control and favorable overall survival. There is a need for longer follow-up than has commonly been used for the proper evaluation of failures after an effective regimen of preoperative chemoradiation.

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ACKNOWLEDGMENTS

The authors thank the contributions of the following surgeons, radiation oncologists, medical oncologists, statisticians, and data managers who participated in this trial: Queensland: K. Baumann, B.Sc. Med.Tech., A. Bell, M.B.B.S.(Hons.), F.R.A.C.S., F.R.C.S., J. Harvey, M.B.B.S., F.R.A.C.R., J. Mac-Kinstosh, M.B.B.S., F.R.A.C.P., E. Walpole, M.B.B.S., F.R.A.C.P.; Victoria: V. Ganju, M.B.B.S., J. McLeish, M.B.B.S., F.R.A.C.S., K. Richards, M.B.B.S.(Hons.), M. Michael, B.Sc.(Hons.), M.B.B.S., F.R.A.C.P., G. Richardson, M.B.B.S., F.R.A.C.P., J. Smith, Ph.D., A.Stat., B. Waxman, M.B.B.S.(Hons.), B.Med.Sc.(Hons.), F.R.A.C.S., F.R.C.S.; New South Wales: J. Cartmill, M.B.B.S., M.Med., F.R.A.C.S., S. Della-Fiorentina, M.B.B.S., F.R.A.C.P., P. Douglas, B.Sc.(Med.), M.B.B.S., F.R.A.C.S., A. Gatenby, M.B.B.S., F.R.C.S., F.R.A.C.S., P. Van Gelderen, M.B.B.S., F.R.A.C.S., K. Mcdonald, R.N., C. Wong, M.B.B.S., F.R.A.C.S., F.R.C.S.(Edinb.), M. Wright, B.App.Sc., B. Yeo, M.B.B.S., F.R.C.S., F.R.A.C.S., Y. Zissiadis, M.B.B.S., F.R.A.C.R.; Western Australia: J. Aitken, M.B.B.S., F.R.C.S., F.R.C.S.(SA), F.R.A.C.S., S. Campbell, M. Levitt M.B.B.S., F.R.A.C.S.

Author information

Authors and Affiliations

  1. Division of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

    Samuel Y. K. Ngan M.B.B.S., F.R.C.S.(Edinb.), F.R.A.N.Z.C.R. & Trevor Leong M.B.B.S., M.D., F.R.A.N.Z.C.R.

  2. Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

    Richard Fisher M.B.B.S., Ph.D. & Beverley McClure B.Sc.(Hons.)

  3. Department of Radiation Oncology, Princess Alexandra Hospital, Brisbane, Queensland, Australia

    Bryan H. Burmeister M.B.Ch.B, F.R.A.N.Z.C.R.

  4. Colorectal Unit, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

    John Mackay M.B.B.S., F.R.A.C.S., F.R.C.S.

  5. Department of Oncology, Prince of Wales Hospital, Sydney, New South Wales, Australia

    David Goldstein M.B.B.S., F.R.A.C.P.

  6. Department of Oncology, Liverpool Hospital, Sydney, New South Wales, Australia

    Andrew Kneebone M.B.B.S., F.R.A.N.Z.C.R.

  7. Colorectal Unit, Princess Alexandra Hospital, Brisbane, Queensland, Australia

    David Schache M.B.B.S., F.R.A.C.S.

  8. Department of Oncology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia

    David Joseph M.B.B.S., F.R.A.N.Z.C.R.

  9. Department of Oncology, Box Hill Hospital, Melbourne, Victoria, Australia

    Joseph McKendrick M.B.B.S., D.M., F.R.A.C.P.

  10. Division of Haematology and Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

    Danny Rischin M.B.B.S., F.R.A.C.P.

Authors
  1. Samuel Y. K. Ngan M.B.B.S., F.R.C.S.(Edinb.), F.R.A.N.Z.C.R.
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  2. Richard Fisher M.B.B.S., Ph.D.
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  3. Bryan H. Burmeister M.B.Ch.B, F.R.A.N.Z.C.R.
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  4. John Mackay M.B.B.S., F.R.A.C.S., F.R.C.S.
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  5. David Goldstein M.B.B.S., F.R.A.C.P.
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  6. Andrew Kneebone M.B.B.S., F.R.A.N.Z.C.R.
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  7. David Schache M.B.B.S., F.R.A.C.S.
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  8. David Joseph M.B.B.S., F.R.A.N.Z.C.R.
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  9. Joseph McKendrick M.B.B.S., D.M., F.R.A.C.P.
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  10. Trevor Leong M.B.B.S., M.D., F.R.A.N.Z.C.R.
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  11. Beverley McClure B.Sc.(Hons.)
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  12. Danny Rischin M.B.B.S., F.R.A.C.P.
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Corresponding author

Correspondence to Samuel Y. K. Ngan M.B.B.S., F.R.C.S.(Edinb.), F.R.A.N.Z.C.R..

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Ngan, S., Fisher, R., Burmeister, B. et al. Promising Results of a Cooperative Group Phase II Trial of Preoperative Chemoradiation for Locally Advanced Rectal Cancer (TROG 9801). Dis Colon Rectum 48, 1389–1396 (2005). https://doi.org/10.1007/s10350-005-0032-x

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  • DOI: https://doi.org/10.1007/s10350-005-0032-x

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