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Intraoperative radiotherapy for resectable advanced lower rectal cancer—final results of a randomized controlled trial (UMIN000021353)

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Abstract

Aim

Pelvic autonomic nerve preservation (PANP) is useful to preserve voiding and sexual function after rectal cancer surgery. The aim of this study was to investigate the benefit of intraoperative radiotherapy (IORT) to have complete PANP without affecting oncological outcomes.

Methods

Patients undergoing potentially curative resection of the rectum were included. They were randomized to intraoperative radiotherapy of the completely preserved bilateral pelvic nerve plexuses (IORT group) or the control group without IORT, but with limited nerve preservation. The primary endpoint was pelvic sidewall recurrence. Moreover, patients’ clinicopathologic parameters, postoperative complications, voiding function, and other oncologic outcomes were compared.

Results

From 79 patients, three were excluded from analysis, resulting in 38 patients in each group. Patients’ demographic and pathological parameters were well balanced between the two groups. The trial was terminated prematurely in July 2017, because distant metastasis-free survivals were found to be significantly worse in the IORT group compared to the control group (odds ratio 2.554; 95% CI, 1.041 ~ 6.269; p = 0.041). Neither overall survival nor pelvic sidewall recurrence did differ between the two groups (overall survival: odds ratio 1.264; 95% CI, 0.523~3.051; p = 0.603/pelvic sidewall recurrence; odds ratio 1.350; 95% CI, 0.302~6.034; p = 0.694). Postoperative complications did not differ between the groups; however, the urinary function was significantly better in the IORT group in the short and long term.

Conclusion

With the aid of IORT, complete PANP can be done without increase of pelvic sidewall recurrence; however, IORT may increase the incidence of distant metastases. Therefore, IORT cannot be recommended as a standard therapy to compensate less radical resection for advanced lower rectal cancer.

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Acknowledgments

The authors express sincere thanks to all of the participants of this trial, nurses, anesthesiologists, and medical staffs of the Radiology Department of Kyorin University Hospital.

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Authors and Affiliations

  1. Department of Surgery, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan

    Tadahiko Masaki, Hiroyoshi Matsuoka, Tomokazu Kishiki, Koichiro Kojima, Nobuyoshi Aso, Ayumi Beniya, Nobutsugu Abe & Eiji Sunami

  2. Department of Radiation Oncology, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan

    Ayako Tonari & Makoto Takayama

Authors
  1. Tadahiko Masaki
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  2. Hiroyoshi Matsuoka
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  3. Tomokazu Kishiki
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  4. Koichiro Kojima
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  5. Nobuyoshi Aso
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  6. Ayumi Beniya
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  7. Ayako Tonari
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  8. Makoto Takayama
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  9. Nobutsugu Abe
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  10. Eiji Sunami
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Contributions

Study conception and design: Tadahiko Masaki, Makoto Takayama, Ayako Tonari. Acquisition of data: Hiroyoshi Matsuoka, Tomokazu Kishiki, Koichiro Kojima, Nobuyoshi Asoh, Ayumi Beniya. Analysis and interpretation of data: Tadahiko Masaki. Drafting of manuscript: Nobutsugu Abe. Critical revision of manuscript: Eiji Sunami.

Corresponding author

Correspondence to Tadahiko Masaki.

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Conflict of interest

The authors declare that they have no conflicts of interest.

Ethical approval

All procedures performed in this study were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Masaki, T., Matsuoka, H., Kishiki, T. et al. Intraoperative radiotherapy for resectable advanced lower rectal cancer—final results of a randomized controlled trial (UMIN000021353). Langenbecks Arch Surg 405, 247–254 (2020). https://doi.org/10.1007/s00423-020-01875-2

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  • DOI: https://doi.org/10.1007/s00423-020-01875-2

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