A Non-Randomised Comparative Phase II Trial of Doxycycline as a Cancer Stem Cell Inhibitor in Patients Undergoing Short-Course Radiotherapy Followed by Surgical Resection for Rectal Cancer

Dr Natalie Briggs0 个研究点目标入组 40 人开始时间: 2020年8月14日最近更新: 2020年8月24日

适应症

试验速览

暂无简介。

•1. Pathologically-confirmed rectal adenocarcinoma.
•2. Magnetic resonance imaging (MRI) stage T3-4, and/or N1-2, or full thickness low T2 lesions where R0 resectability is in doubt.
•3. ECOG performance status of 0–2.
•4. Adequate liver function on blood tests taken within four weeks of commencing doxycycline (e.g. ALT/AST <3 x ULN, bilirubin <1.5 x ULN).
•5. Surgery planned to occur within 3 weeks of starting SCRT.
•6. Willing and able to comply with all trial requirements, including treatment and timing and/or nature of required assessments.
•7. Signed, written informed consent.

•1. Received chemotherapy for their rectal cancer prior to SCRT;
•2. Allergy to doxycycline.
•3. Currently taking medications with which doxycycline is known to have clinically-significant drug-drug interactions including systemic retinoids, oral antacids, oral iron or calcium, carbamazepine, phenytoin, enzalutamide, lithium, ergotamine, diuretics, oral contraceptive pill, quinapril, rifampicin, warfarin, methotrexate, st johns wort, ciclosporin.
•4. Myasthenia gravis;
•5. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.
•6. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
•7. Prior high dose radiotherapy to the pelvis.
•8. 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 starting treatment. Men must have been surgically sterilised or use a barrier method of contraception.

发起方

Dr Natalie Briggs