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Clinical Trial
. 2022 Dec 28;17(1):214.
doi: 10.1186/s13014-022-02182-4.

The safety of an MRI simulation-guided boost after short-course preoperative radiotherapy for unresectable rectal cancer (SUNRISE): interim analysis of a randomized phase II trial

Wen-Yang Liu #  1 , Jin-Ming Shi #  1 , Ning Li  1 , Xin Wang  2 , Yuan-Hong Gao  3 , Yihebali Chi  4 , Yong-Kun Sun  4 , Qing Zhao  5 , Yong-Jian Zhu  5 , Hong-Da Chen  6 , Hui Fang  1 , Ning-Ning Lu  1 , Shu-Nan Qi  1 , Bo Chen  1 , Shu-Lian Wang  1 , Yong-Wen Song  1 , Yue-Ping Liu  1 , Ye-Xiong Li  1 , Zheng Liu  7 , Hai-Tao Zhou  7 , Jian-Wei Liang  7 , Xi-Shan Wang  7 , Hai-Zeng Zhang  7 , Yuan Tang  8 , Jing Jin  9   10
Affiliations
Clinical Trial

The safety of an MRI simulation-guided boost after short-course preoperative radiotherapy for unresectable rectal cancer (SUNRISE): interim analysis of a randomized phase II trial

Wen-Yang Liu et al. Radiat Oncol. .

Abstract

Purpose: The safety of an MRI simulation-guided boost after short-course preoperative radiotherapy (SCPRT) for unresectable rectal cancer is assessed with a planned interim analysis.

Methods and materials: Patients diagnosed with clinical stage T3-4 or regional lymph node-positive disease with positive mesorectal fascia or T4b disease evaluated by pelvic MRI were randomly assigned to the SCPRT-boost group (25 Gy in 5 fractions plus 4 Gy delivered to the gross tumor volume, followed by four cycles of chemotherapy) or preoperative chemoradiotherapy group (50 Gy in 25 fractions with concurrent chemotherapy). Then, patients received total mesorectal excision surgery after preoperative treatment. The primary endpoint was the R0 resection rate. The interim analysis was performed when 42 patients completed their assigned treatments.

Results: From October 2018 to November 2019, a total of 43 patients were enrolled, and 42 patients were included in the interim analysis. During preoperative therapy, grade 3 or above toxicities were observed in 10/21 (47.6%) patients in the experimental group, and 4/21 (19.0%) patients in the control group. A total of 17 (81.0%) and 13 (61.9%) patients in the experimental group and control group underwent surgery, respectively. Overall, 65.1% of the patients achieved R0 resection in the intention-to-treat analysis. Surgery-related adverse complications were observed in 2 patients (11.8%) in the experimental group and 1 patient (7.7%) in the control group.

Conclusion: Our results show that the toxicity of an MRI simulation-guided boost after SCPRT for unresectable rectal cancer is acceptable. Thus, this clinical trial will be continued as planned.

Keywords: MRI; Preoperative; Radiotherapy boost; Rectal cancer.

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Conflict of interest statement

There are neither relationships with industry and organizations in this study, nor potential conflicts of interest between authors and other persons.

Figures

Fig. 1
Fig. 1
Study Flowchart (MDT: multiple disciplinary team; RT: radiotherapy; CRT: chemoradiotherapy)
Fig. 2
Fig. 2
Example of target volume delineation of the boost area for the gross tumor on MRI simulation image (GTV: red, PGTV: blue)
See this image and copyright information in PMC

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References

    1. Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–249. doi: 10.3322/caac.21660. - DOI - PubMed
    1. Devine RM, Dozois RR. Surgical management of locally advanced adenocarcinoma of the rectum. World J Surg. 1992;16(3):486–489. doi: 10.1007/BF02104452. - DOI - PubMed
    1. Braendengen M, Tveit KM, Berglund A, et al. Randomized phase III study comparing preoperative radiotherapy with chemoradiotherapy in nonresectable rectal cancer. J Clin Oncol. 2008;26(22):3687–3694. doi: 10.1200/JCO.2007.15.3858. - DOI - PubMed
    1. Glynne-Jones R, Wyrwicz L, Tiret E, et al. Rectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017;28(suppl_4):iv22–iv40. doi: 10.1093/annonc/mdx224. - DOI - PubMed
    1. Bujko K, Wyrwicz L, Rutkowski A, et al. Long-course oxaliplatin-based preoperative chemoradiation versus 5 × 5 Gy and consolidation chemotherapy for cT4 or fixed cT3 rectal cancer: results of a randomized phase III study. Ann Oncol. 2016;27(5):834–842. doi: 10.1093/annonc/mdw062. - DOI - PubMed

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