Induction Versus Consolidation Chemotherapy in Total Neoadjuvant Therapy of Locally Advanced Rectal Cancer With High Risk of Recurrence (ICONA Study)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- complete remission rate
研究概览
简要总结
The purpose of this study is to identify the most promising treatment sequence in total neoadjuvant therapy for locally advanced rectal cancer with a high risk of recurrence.
详细描述
International recommendations for the treatment of locally advanced rectal cancer with a high risk of disease recurrence are inconsistent regarding the optimal sequence of total neoadjuvant therapy. In a German randomized study, a higher rate of pathological complete response was observed with consolidation chemotherapy.
This study compares induction chemotherapy followed by chemoradiotherapy and consolidation chemotherapy with chemoradiotherapy followed by consolidation chemotherapy in patients with locally advanced rectal cancer and high-risk features for recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically proven rectal adenocarcinoma
- •no distant metastases on CT scan (M0 disease)
- •at least one high risk factor for disease recurrence identified on magnetic resonance imaging (MRI):
- •T4 tumor (cT4)
- •N2 disease (cN2)
- •extramural venous invasion (cEMVI+)
- •positive lateral lymph nodes
- •distance of tumor to mesorectal fascia or positive lymph nodes is 1 mm or less (cMRF+)
- •capacity for informed consent
- •willingness to attend regular check-ups during and after treatment
排除标准
- •history of previous irradiation in the pelvic area
- •absolute contraindications for MR imaging
- •distant metastases cannot be reliably excluded
- •synchronous cancer
- •chronic inflammatory bowel disease
研究组 & 干预措施
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.
干预措施: Consolidation CAPOX Chemotherapy (Drug)
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.
干预措施: Induction CAPOX Chemotherapy (Drug)
结局指标
主要结局
complete remission rate
时间窗: 2 weeks after completiton of TNT
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.
complete remission rate
时间窗: 2 weeks after completion of TNT
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.
次要结局
- local control(after 3 years of follow-up)
- Overall survival(after 3 years of follow-up)
- Disease free survival(after 3 years of follow-up)
- Survival without recurrence of the disease(after 3 years of follow-up)
研究者
Neža Gros
Principal Investigator
Institute of Oncology Ljubljana