A randomized, placebo-controlled phase II trial of Simvastatin in addition to standard chemotherapy and radiation in preoperative treatment for rectal cancer

The Australasian Gastro-Intestinal Trials Group (AGITG)0 个研究点目标入组 222 人开始时间: 2017年7月26日最近更新: 2023年7月18日

适应症

试验速览

暂无简介。

•1. Males or females with biopsy proven rectal adenocarcinoma, or high-grade dysplasia with radiological evidence of invasive tumour
•2. Distal border of the tumour is below the peritoneal reflection as assessed by MRI scan
•3. Age more than or equal to 18 years
•4. Clinical TNM tumour staging is T2-4 N0-2 M0 after staging investigations including CT scan of chest, abdomen and pelvis and pelvic MRI scan
•5. Planned for concurrent long-course pCRT using fluoropyrimidine-based chemotherapy
•6. Radiologically-measureable disease on baseline pelvic MRI scan
•7. Adequate bone marrow function (e.g. platelets >100 x 109/L, neutrophils >1.5 x 109/L)
•8. Adequate liver function (e.g. ALT/AST <3 x ULN, bilirubin <1.5 x ULN)
•9. Adequate renal function (e.g. estimated creatinine clearance >50 ml/min)
•10. Trial treatment planned to start within 28 days of randomisation
•11. Diagnostic biopsy of rectal tumour is available for histological substudies
•12. Willing and able to comply with all trial requirements, including treatment (e.g. able to swallow tablets), timing and/or nature of required assessments (e.g. able to have IV contrast if this is required for tumour assessments)
•13. Signed, written informed consent for the main trial

•1. Contraindications or hypersensitivity to statins, fluoropyrimidine chemotherapy or radiotherapy
•2. Patients planned to receive oxaliplatin or biological agents (e.g. cetuximab) as part of pCRT
•3. Taking statins in the 6 weeks before planned start of pCRT
•4. Predicted life expectancy of less than 3 years
•5. Prior pelvic or rectal radiotherapy
•6. History of another malignancy within 5 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 5 years after definitive primary treatment
•7. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
•8. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
•9. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.

发起方

The Australasian Gastro-Intestinal Trials Group (AGITG)