[Comment] Preoperative sequential short-course radiation therapy and FOLFOX chemotherapy versus long-course chemoradiotherapy for locally advanced rectal cancer: a multicenter, randomized controlled trial (SOLAR trial)
[Background] Preoperative (chemo)radiotherapy has been widely used as an effective treatment for locally advanced rectal cancer (LARC), leading to a significant reduction in pelvic recurrence rates. Because early administration of intensive chemotherapy for LARC has more advantages than adjuvant che...
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Editorial Office of Journal of Colorectal & Anal Surgery
2024-02-01
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| Series: | 结直肠肛门外科 |
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| Online Access: | https://jcas.gxmuyfy.cn/cn/wqll/paper.html?id=39&cateName=2024%E5%B9%B4%20%E7%AC%AC30%E5%8D%B7%20%E7%AC%AC1%E6%9C%9F |
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| author | Wang Yuchen Li Jiannan |
| author_facet | Wang Yuchen Li Jiannan |
| author_sort | Wang Yuchen |
| collection | DOAJ |
| description | [Background] Preoperative (chemo)radiotherapy has been widely used as an effective treatment for locally advanced rectal cancer (LARC), leading to a significant reduction in pelvic recurrence rates. Because early administration of intensive chemotherapy for LARC has more advantages than adjuvant chemotherapy, total neoadjuvant therapy (TNT) has been introduced and evaluated to determine whether it can improve tumor response or treatment outcomes. This study aims to investigate whether short-course radiotherapy (SCRT) followed by intensive chemotherapy improves oncologic outcomes compared with traditional preoperative long-course chemoradiotherapy (CRT). [Methods] A multicenter randomized phase Ⅱ trial involving 364 patients with LARC (cT3-4, cN+, or presence of extramural vascular invasion) will be conducted. Patients will be randomly assigned to the experimental or control arm at a ratio of 1:1. Participants in the experimental arm will receive SCRT (25 Gy in 5 fractions, daily) followed by four cycles of FOLFOX (oxaliplatin, 5-fluorouracil, and folinic acid) as a neoadjuvant treatment, and those in the control arm will receive conventional radiotherapy (45-50.4 Gy in 25-28 fractions, 5 times a week) concurrently with capecitabine or 5-fluorouracil. As a mandatory surgical procedure, total mesorectal excision will be performed 2-5 weeks from the last cycle of chemotherapy in the experimental arm and 6-8 weeks after the last day of radiotherapy in the control arm. The primary endpoint is 3-year disease-free survival, and the secondary endpoints are tumor response, overall survival, toxicities, quality of life, and cost-effectiveness. [Discussion] This is the first Korean randomized controlled study comparing SCRT-based TNT with traditional preoperative LC-CRT for LARC. The involvement of experienced colorectal surgeons ensures high-quality surgical resection. SCRT followed by FOLFOX chemotherapy is expected to improve disease-free survival compared with CRT, with potential advantages in tumor response, quality of life, and cost-effectiveness. |
| format | Article |
| id | doaj-art-9aa77c77a7004567ab7cb63f8c1229cc |
| institution | DOAJ |
| issn | 1674-0491 |
| language | zho |
| publishDate | 2024-02-01 |
| publisher | Editorial Office of Journal of Colorectal & Anal Surgery |
| record_format | Article |
| series | 结直肠肛门外科 |
| spelling | doaj-art-9aa77c77a7004567ab7cb63f8c1229cc2025-08-20T03:10:03ZzhoEditorial Office of Journal of Colorectal & Anal Surgery结直肠肛门外科1674-04912024-02-01301909210.19668/j.cnki.issn1674-0491.2024.01.016[Comment] Preoperative sequential short-course radiation therapy and FOLFOX chemotherapy versus long-course chemoradiotherapy for locally advanced rectal cancer: a multicenter, randomized controlled trial (SOLAR trial)Wang YuchenLi Jiannan[Background] Preoperative (chemo)radiotherapy has been widely used as an effective treatment for locally advanced rectal cancer (LARC), leading to a significant reduction in pelvic recurrence rates. Because early administration of intensive chemotherapy for LARC has more advantages than adjuvant chemotherapy, total neoadjuvant therapy (TNT) has been introduced and evaluated to determine whether it can improve tumor response or treatment outcomes. This study aims to investigate whether short-course radiotherapy (SCRT) followed by intensive chemotherapy improves oncologic outcomes compared with traditional preoperative long-course chemoradiotherapy (CRT). [Methods] A multicenter randomized phase Ⅱ trial involving 364 patients with LARC (cT3-4, cN+, or presence of extramural vascular invasion) will be conducted. Patients will be randomly assigned to the experimental or control arm at a ratio of 1:1. Participants in the experimental arm will receive SCRT (25 Gy in 5 fractions, daily) followed by four cycles of FOLFOX (oxaliplatin, 5-fluorouracil, and folinic acid) as a neoadjuvant treatment, and those in the control arm will receive conventional radiotherapy (45-50.4 Gy in 25-28 fractions, 5 times a week) concurrently with capecitabine or 5-fluorouracil. As a mandatory surgical procedure, total mesorectal excision will be performed 2-5 weeks from the last cycle of chemotherapy in the experimental arm and 6-8 weeks after the last day of radiotherapy in the control arm. The primary endpoint is 3-year disease-free survival, and the secondary endpoints are tumor response, overall survival, toxicities, quality of life, and cost-effectiveness. [Discussion] This is the first Korean randomized controlled study comparing SCRT-based TNT with traditional preoperative LC-CRT for LARC. The involvement of experienced colorectal surgeons ensures high-quality surgical resection. SCRT followed by FOLFOX chemotherapy is expected to improve disease-free survival compared with CRT, with potential advantages in tumor response, quality of life, and cost-effectiveness.https://jcas.gxmuyfy.cn/cn/wqll/paper.html?id=39&cateName=2024%E5%B9%B4%20%E7%AC%AC30%E5%8D%B7%20%E7%AC%AC1%E6%9C%9Frectal neoplasmneoadjuvant radiotherapyshort-course radiationconsolidation chemotherapydisease-free survivalrandomized controlled phase ⅱ trialprotocol |
| spellingShingle | Wang Yuchen Li Jiannan [Comment] Preoperative sequential short-course radiation therapy and FOLFOX chemotherapy versus long-course chemoradiotherapy for locally advanced rectal cancer: a multicenter, randomized controlled trial (SOLAR trial) 结直肠肛门外科 rectal neoplasm neoadjuvant radiotherapy short-course radiation consolidation chemotherapy disease-free survival randomized controlled phase ⅱ trial protocol |
| title | [Comment] Preoperative sequential short-course radiation therapy and FOLFOX chemotherapy versus long-course chemoradiotherapy for locally advanced rectal cancer: a multicenter, randomized controlled trial (SOLAR trial) |
| title_full | [Comment] Preoperative sequential short-course radiation therapy and FOLFOX chemotherapy versus long-course chemoradiotherapy for locally advanced rectal cancer: a multicenter, randomized controlled trial (SOLAR trial) |
| title_fullStr | [Comment] Preoperative sequential short-course radiation therapy and FOLFOX chemotherapy versus long-course chemoradiotherapy for locally advanced rectal cancer: a multicenter, randomized controlled trial (SOLAR trial) |
| title_full_unstemmed | [Comment] Preoperative sequential short-course radiation therapy and FOLFOX chemotherapy versus long-course chemoradiotherapy for locally advanced rectal cancer: a multicenter, randomized controlled trial (SOLAR trial) |
| title_short | [Comment] Preoperative sequential short-course radiation therapy and FOLFOX chemotherapy versus long-course chemoradiotherapy for locally advanced rectal cancer: a multicenter, randomized controlled trial (SOLAR trial) |
| title_sort | comment preoperative sequential short course radiation therapy and folfox chemotherapy versus long course chemoradiotherapy for locally advanced rectal cancer a multicenter randomized controlled trial solar trial |
| topic | rectal neoplasm neoadjuvant radiotherapy short-course radiation consolidation chemotherapy disease-free survival randomized controlled phase ⅱ trial protocol |
| url | https://jcas.gxmuyfy.cn/cn/wqll/paper.html?id=39&cateName=2024%E5%B9%B4%20%E7%AC%AC30%E5%8D%B7%20%E7%AC%AC1%E6%9C%9F |
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