巩固与诱导化疗在高复发风险直肠癌全新辅助治疗中的比较 (ICONA)
具有高复发风险的局部晚期直肠癌的全新辅助治疗中的诱导与巩固化疗（ICONA 研究）
研究概览
详细说明
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习地点
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Slovenia
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Ljubljana、Slovenia、斯洛文尼亚、1000
- Institute of Oncology
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准：- 经组织学证实的直肠腺癌
- CT 扫描无远处转移（M0 病）
在 MR 成像中至少确定了一个疾病复发的高危因素：
- T4 肿瘤 (cT4)
- N2 病 (cN2)
- 壁外静脉侵犯 (cEMVI+)
- 侧方淋巴结阳性
- 肿瘤与直肠系膜筋膜或阳性淋巴结的距离小于或等于 1 毫米 (cMRF+)
- 知情同意的能力
- 愿意在治疗期间和治疗后参加定期检查
排除标准：既往盆腔照射史
- MR 成像的绝对禁忌症
- 不能可靠地排除远处转移
- 同步癌症
- 慢性炎症性肠病
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：consolidation chemotherapy
chemoradiation: intensity-modulated irradiation technique with simultaneous integrated boost to the tumor (IMRT-SIB) or with volumetric modulated arc therapy (VMAT) with simultaneous integrated boost (VMAT-SIB) to the total tumor dose of 46.2 Gy in T1-3 tumors and 48.4 Gy in T4 tumors in 22 fractions with concomitant chemotherapy (CT) with capecitabine (dosage: 825 mg / m2 / 12 h per os continuously from the first to the last day of irradiation). 6 cycles of capecitabine and oxaliplatin (CAPOX) chemotherapy. One cycle of CAPOX CT lasts 3 weeks and consists of capecitabine 1000 mg / m2 / 12h per os for 1-14 days and oxaliplatin 130 mg / m2 intravenously in a two-hour infusion on day 1. |
Six cycles of CAPOX chemotherapy are administered after chemoradiotherapy.
CAPOX consists of capecitabine and oxaliplatin according to the study protocol.
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有源比较器：induction chemotherapy
4 cycles of induction CAPOX chemotherapy. One cycle of CAPOX CT lasts 3 weeks and consists of capecitabine 1000 mg / m2 / 12h per os for 1-14 days and oxaliplatin 130 mg / m2 intravenously in a two-hour infusion on day 1. Chemoradiation: intensity-modulated irradiation technique with simultaneous integrated boost to the tumor (IMRT-SIB) or with volumetric modulated arc therapy (VMAT) with simultaneous integrated boost (VMAT-SIB) to the total tumor dose of 46.2 Gy in T1-3 tumors and 48.4 Gy in T4 tumors in 22 fractions with concomitant CT with capecitabine (dosage: 825 mg / m2 / 12 h per os continuously from the first to the last day of irradiation). 2 cycles of consolidation CAPOX chemotherapy. |
Four cycles of CAPOX chemotherapy are administered before chemoradiotherapy, followed by two cycles of CAPOX chemotherapy after chemoradiotherapy.
CAPOX consists of capecitabine and oxaliplatin according to the study protocol.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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complete remission rate
大体时间：2 weeks after completion of TNT
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The proportion of complete responses will be defined as the sum of the proportions of pCR in operated patients and cCR in non-operated patients.
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2 weeks after completion of TNT
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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总生存期
大体时间：经过 3 年的随访
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从随机分组到死亡的时间
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经过 3 年的随访
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无病生存
大体时间：经过 3 年的随访
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从治疗（对于 cCR）或手术结束到疾病复发、新癌症发作、死于癌症或其他原因的时间
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经过 3 年的随访
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本地控制
大体时间：经过 3 年的随访
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从治疗结束（对于 cCR）或手术到局部复发的时间
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经过 3 年的随访
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Survival without recurrence of the disease
大体时间：after 3 years of follow-up
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time from the end of treatment (in case of cCR) or from radical surgery to death or recurrence of the disease - whichever comes first.
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after 3 years of follow-up
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合作者和调查者
调查人员
- 首席研究员：Vaneja Velenik, PD、Institute of Oncology Ljubljana
出版物和有用的链接
一般刊物
- Cercek A, Goodman KA, Hajj C, Weisberger E, Segal NH, Reidy-Lagunes DL, Stadler ZK, Wu AJ, Weiser MR, Paty PB, Guillem JG, Nash GM, Temple LK, Garcia-Aguilar J, Saltz LB. Neoadjuvant chemotherapy first, followed by chemoradiation and then surgery, in the management of locally advanced rectal cancer. J Natl Compr Canc Netw. 2014 Apr;12(4):513-9. doi: 10.6004/jnccn.2014.0056.
- Tuta M, Boc N, Brecelj E, Peternel M, Velenik V. Total neoadjuvant therapy vs standard therapy of locally advanced rectal cancer with high-risk factors for failure. World J Gastrointest Oncol. 2021 Feb 15;13(2):119-130. doi: 10.4251/wjgo.v13.i2.119.
- Tuta M, Boc N, Brecelj E, Omejc M, Anderluh F, Ermenc AS, Peressutti AJ, Oblak I, Krebs B, Velenik V. Total neoadjuvant treatment of locally advanced rectal cancer with high risk factors in Slovenia. Radiol Oncol. 2019 Oct 25;53(4):465-472. doi: 10.2478/raon-2019-0046.
- Fokas E, Allgauer M, Polat B, Klautke G, Grabenbauer GG, Fietkau R, Kuhnt T, Staib L, Brunner T, Grosu AL, Schmiegel W, Jacobasch L, Weitz J, Folprecht G, Schlenska-Lange A, Flentje M, Germer CT, Grutzmann R, Schwarzbach M, Paolucci V, Bechstein WO, Friede T, Ghadimi M, Hofheinz RD, Rodel C; German Rectal Cancer Study Group. Randomized Phase II Trial of Chemoradiotherapy Plus Induction or Consolidation Chemotherapy as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: CAO/ARO/AIO-12. J Clin Oncol. 2019 Dec 1;37(34):3212-3222. doi: 10.1200/JCO.19.00308. Epub 2019 May 31.
- Golo D, But-Hadzic J, Anderluh F, Brecelj E, Edhemovic I, Jeromen A, Omejc M, Oblak I, Secerov-Ermenc A, Velenik V. Induction chemotherapy, chemoradiotherapy and consolidation chemotherapy in preoperative treatment of rectal cancer - long-term results of phase II OIGIT-01 Trial. Radiol Oncol. 2018 Sep 11;52(3):267-274. doi: 10.2478/raon-2018-0028.
- But-Hadzic J, Anderluh F, Brecelj E, Edhemovic I, Secerov-Ermenc A, Hudej R, Jeromen A, Kozelj M, Krebs B, Oblak I, Omejc M, Vogrin A, Velenik V. Acute Toxicity and Tumor Response in Locally Advanced Rectal Cancer After Preoperative Chemoradiation Therapy With Shortening of the Overall Treatment Time Using Intensity-Modulated Radiation Therapy With Simultaneous Integrated Boost: A Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2016 Dec 1;96(5):1003-1010. doi: 10.1016/j.ijrobp.2016.08.031. Epub 2016 Aug 31.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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