2023-506703-26-00招募中3 期
Efficacy and safety of conventional neoadjuvant therapy versus total neoadjuvant therapy in older patients with locally advanced rectal cancer: a multicentre, open-label, randomised pragmatic clinical trial
Institut Jules Bordet18 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2024年1月8日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 18
- 主要终点
- The primary endpoint is Net Benefit Treatment, according to the following hierarchical outcome measures: 1. Overall survival at 3 years after randomisation 2. Progression-free survival at 3 years after randomisation 3. Increased-grade peripheral sensory neuropathy at 3 years after randomisation 4. Grade ≥3 toxicities during treatment
研究概览
简要总结
The primary objective of the trial is to demonstrate that a neoadjuvant treatment strategy of SCRT or LCCRT followed by surgery plus or minus adjuvant chemotherapy is a better trade-off between efficacy and safety than total neoadjuvant therapy (TNT) in an older rectal cancer population.
研究设计
- 分配方式
- Randomized
- 主要目的
- Main Trial
- 盲法
- None
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 70 years old
- •Signed Informed Consent form (ICF) obtained prior to any study related procedure.
- •Male subjects with partners of childbearing potential must agree to use condom during the course of this study and for at least 6 months after the last administration of study drugs.
- •ECOG performance status (PS): ≤1 if age > 75 years old, ≤2 if age ≤ 75 years old
- •Histologically or cytologically confirmed adenocarcinoma of the rectum
- •Distal border of the tumour below the peritoneal reflection and within 15 cm of the anal verge
- •Operable stage III or high-risk stage II rectal cancer (high-risk tumours defined as those having ≥1 of the following features: T4, mesorectal fascia (MRF) involvement/threatening [i.e.,tumour within 1 mm of the MRF], extramural venous invasion). Patient with involvement of lateral pelvic lymph nodes are also eligible.
- •Adequate bone marrow function as defined below: - Absolute neutrophil count ≥1,500/µL - Haemoglobin ≥9 g/dL - Platelets ≥100,000/µL
- •Adequate liver function as defined below: - Serum total bilirubin ≤1.5 x ULN. In case of known Gilbert’s syndrome <3xUNL is allowed - AST (SGOT) and ALT (SGPT) ≤2.5 x ULN - Alkaline phosphatase ≤2.5 x ULN
- •Adequate renal function as defined by estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73m² (according to the CKD-EPI 2021 equation)
- •Absence of clinical conditions that in the opinion of the investigator, would contraindicate neoadjuvant therapy and/or surgery.
排除标准
- •Extensive growth into cranial part of the sacrum (above S2/3 junction) or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumour down-sizing is achieved.
- •Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment.
- •Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure (grade III or IV as classified by the New York Heart Association), or serious cardiac arrhythmia requiring medication medication within the past 6 months.
- •Use of brivudine, sorivudine or their chemically related analogues.
- •Complete dihydropyrimidine dehydrogenase (DPD) deficiency.
- •Any previous treatment for rectal cancer
- •Presence of metastatic disease or recurrent rectal tumour.
- •Presence of grade ≥2 peripheral neuropathy according to the Common Toxicity Criteria for Adverse Events (CTCAE) v.5.
- •Significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator’s opinion, may interfere with completion of the study.
- •Any contraindication to pelvic irradiation as evaluated by the investigator.
- •Known hypersensitivity reactions to the study drugs or to any excipients, premedications or non-investigational medicinal products or concomitant medications.
- •Any investigational anti-cancer therapy other than the protocol specified therapies (participation in other prospective studies which do not imply any specific intervention may be allowed after discussion with the Study Chair).
结局指标
主要结局
The primary endpoint is Net Benefit Treatment, according to the following hierarchical outcome measures: 1. Overall survival at 3 years after randomisation 2. Progression-free survival at 3 years after randomisation 3. Increased-grade peripheral sensory neuropathy at 3 years after randomisation 4. Grade ≥3 toxicities during treatment
The primary endpoint is Net Benefit Treatment, according to the following hierarchical outcome measures: 1. Overall survival at 3 years after randomisation 2. Progression-free survival at 3 years after randomisation 3. Increased-grade peripheral sensory neuropathy at 3 years after randomisation 4. Grade ≥3 toxicities during treatment
次要结局
- Safety of study treatments defined as the frequency of adverse events reported according to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
- Quality of Life based on EORTC-QLQ-C30, EORTC-QLQ-C29, EORTC-QLQ-CIPN20 and EQ-5Q-5L questionnaires
- Compliance to treatment
- Pathological complete response
- R0 resection
- Organ preservation
- Use of healthcare resources
研究者
Clinical Trial Support Unit
Scientific
Institut Jules Bordet
研究点 (18)
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