2024-513920-40-00招募中2 期
VshoRT-R3: Phase 1/2 study of valproic acid and short-course radiotherapy plus capecitabine as preoperatIve treatment in low-moderate risk rectal cancer
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Fase 1 : MTD capecitabina MTD capecitabina + acido valproico Fase 2: tasso di TRG1
研究概览
简要总结
Phase 1: to determine the MTD of Capecitabine given alone or in combination with valproic acid during preoperative short-course radiotherapy (SCRT). Phase 2 (comparative): • To explore whether the addition of valproic acid to short-course radiotherapy before optimal radical surgery might increase the pathologic complete tumor regression (TRG1) rate in patient with low-moderate risk rectal cancer. • To explore whether the addition of capecitabine to short-course radiotherapy before optimal radical surgery might increase the pathologic complete tumor regression (TRG1) rate in patient with low-moderate risk rectal cancer.
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
- 是
入选标准
- •Patients with histologically confirmed diagnosis of adenocarcinoma of rectum falling into one of the following categories: • T2N0 located at <2 cm from anal verge • T2N1 or T3N0-N1, located at >5 cm and <12 cm from anal verge and infiltration of perirectal fat up to a minimum distance of1 mm from mesorectal fascia (MRF) evaluated by MRI. • Age ≥18 and ≤ 75 • ECOG Performance Status ≤1 • Effective contraception for both male and female patients if the risk of conception exist • Signed written informed consent
排除标准
- •Any previous treatment for rectal cancer • Previous pelvic radiotherapy • Presence of metastatic disease • Recurrent rectal tumor • Patient with Familial Adenomatosis Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC) • History of inflammatory bowel disease or active disease • Any concurrent malignancy except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of cervix uteri. Patients with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial. • Neutrophils < 2000/mm3 or platelets < 100.000/ mm3 or haemoglobin <9 gr/dl. • Creatinine levels indicating renal clearance of <50 ml/min • GOT and/or GPT > 2.5 time the UNL and/or bilirubin >1.5 time the upper-normal limits (UNL) • Significant cardiovascular comorbidity (e.g. myocardial infarction, superior vena cava [SVC] syndrome, patients with an ejection fraction of <50%) or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia. • History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia. • Patients with long QT-syndrome or QTc interval duration > 480 msec or concomitant medication with drugs prolonging QTc (see list in the appendix) • Known dihydropyrimidine dehydrogenase (DPD) deficiency • HIV positive patients • Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease. • Known or suspected hypersensitivity to any of the study drugs. • Patient who have had prior treatment with an HDAC inhibitor and patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid. • Concurrent uncontrolled medical conditions that might contraindicate study drugs. • Major surgical procedure, within 28 days prior to study treatment start. • Pregnant or lactating women. • Women of childbearing potential with either a positive or no pregnancy test at baseline (NB. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. • Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study
结局指标
主要结局
Fase 1 : MTD capecitabina MTD capecitabina + acido valproico Fase 2: tasso di TRG1
Fase 1 : MTD capecitabina MTD capecitabina + acido valproico Fase 2: tasso di TRG1
次要结局
- Local control, disease free survival and overall survival. • Pathological CRM negative (margin >1 mm) and lymph node negative rate • Short and long-term toxicity • Surgical Complications • Quality of Life
研究者
Maria Carmela Piccirillo
Scientific
IRCCS Istituto Nazionale Tumori Fondazione Pascale
研究点 (3)
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VshoRT-R3: Phase 1/2 study of valproic acid and short-course radiotherapy plus capecitabine as preoperatIve treatment in low-moderate risk rectal cancerlow- risk rectal cancelMedDRA version: 20.0Level: LLTClassification code: 10007446Term: Carcinoma of rectum Class: 10029104CTIS2024-513920-40-00IRCCS Istituto Nazionale Tumori Fondazione Pascale120