Neo-adjuvant FOLFOXIRI and chemoradiotherapy for high risk (“ugly”) locally advanced rectal cancer.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 20
- 主要终点
- To evaluate if the addition of induction chemotherapy with FOLFOXIRI leads to a higher pathological complete response (pCR) rate and clinical complete response (cCR) rate at 1 year in patients with high-risk locally advanced rectal cancer compared to the currently available literature regarding high-risk locally advanced rectal cancer patients treated with (chemo)radiotherapy alone or followed by consolidation chemotherapy
研究概览
简要总结
The primary objective of this study is to evaluate if the addition of induction chemotherapy with FOLFOXIRI leads to a higher pathological complete response (pCR) rate and clinical complete response (cCR) rate at 1 year in patients with hr-LARC compared to the currently available literature regarding hr-LARC patients treated with (chemo)radiotherapy alone or followed by consolidation chemotherapy.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •WHO performance score 0-1
- •Fit for (modified dose) triple chemotherapy (FOLFOXIRI)
- •Histopathologically confirmed rectal cancer
- •Lower border of the tumour located on or below the sigmoidal take-off as established on MRI of the pelvis
- •Confirmed high-risk locally advanced rectal cancer, at high risk of treatment failure, meeting one of the following imaging based criteria: *Tumour invasion of the mesorectal fascia (MRF+); *The presence of grade 4 extramural venous invasion (mrEMVI); *The presence of tumour deposits (TD); *The presence of bilateral extramesorectal lymph nodes with a short-axis size ≥ 7mm (LLN) or extensive LLN involving pelvic side wall structures, at high risk of an incomplete resection
- •Resectable disease as determined on magnetic resonance imaging (MRI) or deemed resectable disease after neo-adjuvant treatment (Expected gross incomplete resection with overt tumour remaining in the patient after resection, tumour invasion in the neuroforamina, encasement of the sciatic nerve and invasion of the cortex from S2 and upwards are considered not resectable)
- •Written informed consent
排除标准
- •Evidence of metastatic disease at time of inclusion or within six months prior to inclusion except for patients with enlarged iliac or inguinal lymph nodes and aspecific lung nodules
- •Homozygous DPD deficiency
- •Any chemotherapy within the past 6 months
- •Any contraindication for the planned systemic therapy (e.g. severe allergy, pregnancy, kidney dysfunction and thrombocytopenia), as determined by the medical oncologist
- •Previous radiotherapy in the pelvic area precluding chemoradiotherapy with a dose of 50-50.4 Gy
- •Any contraindication for the planned chemoradiotherapy (e.g. severe allergy to the chemotherapy agent or no possibility to receive radiotherapy), as determined by the medical oncologist and/or radiation oncologist
- •Any contraindication to undergo surgery, as determined by the surgeon and/or anaesthesiologist
- •Concurrent malignancies that interfere with the planned study treatment or the prognosis of the resected tumour
结局指标
主要结局
To evaluate if the addition of induction chemotherapy with FOLFOXIRI leads to a higher pathological complete response (pCR) rate and clinical complete response (cCR) rate at 1 year in patients with high-risk locally advanced rectal cancer compared to the currently available literature regarding high-risk locally advanced rectal cancer patients treated with (chemo)radiotherapy alone or followed by consolidation chemotherapy
To evaluate if the addition of induction chemotherapy with FOLFOXIRI leads to a higher pathological complete response (pCR) rate and clinical complete response (cCR) rate at 1 year in patients with high-risk locally advanced rectal cancer compared to the currently available literature regarding high-risk locally advanced rectal cancer patients treated with (chemo)radiotherapy alone or followed by consolidation chemotherapy
次要结局
- To determine the disease-free survival
- To determine the overall survival
- To determine the progression-free survival
- To determine the recurrence free survival
- To determine the distant metastasis free survival
- To determine the radiological response after induction chemotherapy
- To determine the radiological response after induction chemotherapy and chemoradiotherapy
- To determine the pathological response as determined by Mandard grading system
- To determine the toxicity related to the administration of induction chemotherapy
- To determine the compliance related to the administration of induction chemotherapy
- To determine the toxicity related to the administration of chemoradiotherapy
- To determine the compliance related to the administration of chemoradiotherapy
- To determine the number of patients undergoing surgery
- To determine the type and extent of surgery after neoadjuvant therapy
- To determine the major surgical complications rate
- To determine the quality of life
- To determine the cost-effectiveness and -utility
- To systematically collect blood and tissue samples for future translational research
研究者
Wetenschapsbureau
Scientific
Catharina Ziekenhuis Stichting