ISRCTN15384496进行中（未招募）2 期
Augmenting RadioTherapy in REctal Cancer to Minimise Invasive Surgery
niversity of Leeds0 个研究点目标入组 140 人开始时间: 2023年10月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients age =18 years old
- •2. ECOG PS 0 or 1
- •3. Capable of informed consent
- •4. Able to fully understand trial treatment enough to provide informed consent
- •5. Biopsy-proven rectal adenocarcinoma
- •6. Staged on high-resolution MRI as: T3b-4a or TanyN1-2 or TanyEMVI+ or with a threatened (<1mm) or involved mesorectal fascia resection margin or breached but not invading other organs or definite pelvic side wall lymph nodes involved (that the MDT feel are not resectable)
- •7. Low tumours with involvement of the anal intersphincteric plane or with levator involvement. The superior extent of macroscopic tumour (primary, EMVI or nodes) is no higher than the S1/2 junction on sagittal MRI.
- •Within 14 days pre-randomisation the following must be met:
- •8. Estimated creatinine clearance =50 mls/min (using a validated creatinine clearance calculation e.g. Cockcroft-Gault or Wright formula)
- •9. Haemoglobin = 9.0g/dL
- •10. Neutrophils >1.5 x 10^9/l
- •11. Platelets >100 x 10^9/l
- •12. Adequate blood coagulation function as evidenced by a prothrombin time (PT) <1.5 x normal
- •13. Alkaline phosphatase (ALP) = 2.5 × upper limit of normal (ULN)
- •14. Serum transaminase (either alanine aminotransferase (ALT) or aspartate aminotransferase (AST)) = 2.5 × ULN
- •15. Total bilirubin =1.5 × ULN except for unconjugated hyperbilirubinemia or Gilbert’s syndrome
排除标准
- •1. Unequivocal distant metastatic disease
- •2. Previous pelvic radiotherapy
- •3. MRI defined predominantly mucinous tumour i.e. more than one third of tumour volume assessed to consist of mucin
- •4. Biopsy-proven neuroendocrine tumour
- •5. Definite MRI pelvic side wall lymph node involvement, invasion of adjacent organ, ischio-rectal fossa involvement
- •6. Pre-existing faecal incontinence for solid stool or chronic diarrhoea (> grade 1 according the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE))
- •7. Defunctioning colostomy or ileostomy
- •8. Prior antineoplastic therapy for rectal cancer
- •9. Pregnant or breast feeding or of child bearing potential and unwilling to use effective contraceptive methods
- •10. On-treatment participation in an interventional clinical study 30 days prior to randomisation
- •11. Other concomitant antineoplastic therapy
- •12. Inability to comply with taking oral capecitabine/AN0025 medication
- •13. Active, uncontrolled infections
- •14. Active, disseminated coagulation disorder
- •15. Clinically significant cardiovascular disease = 6 months before randomisation
- •16. Prior invasive malignancy unless disease free >3 years (excluding basal cell carcinoma of the skin or carcinoma in situ)
- •17. Known allergic reactions to either oxaliplatin or AN0025 or both capecitabine and 5-FU
- •18. On medication with inhibitors of DPD
- •19. Psychosocial issues which may affect treatment compliance
- •20. Prolongation of corrected QT (QTc) interval to >480 msec when electrolyte balance is normal
- •21. Recent occurrence (within 3 months prior to randomisation) of a major thromboembolic event, such as pulmonary embolism or proximal deep vein thrombosis, unless stable on (>14 days) therapeutic anticoagulation (aspirin =325 mg daily or low-molecular-weight heparin (LMWH). Subjects with a history of clinically non-significant thromboembolic events, not requiring anticoagulation, are allowed on study
- •22. Subjects receiving oral warfarin are not eligible for this study (unless warfarin is discontinued at least 7 days prior to commencement of treatment and for the duration of the study, or oral warfarin is converted to LMWH, where local clinical opinion considers this an acceptable option)
- •23. Other systemic and local antitumor therapies such as chemotherapy, anti-tumour immunotherapy, radiotherapy or surgical interventions that may interfere / interact with the proposed treatment as part of the ARTEMIS trial
- •24. Other investigational drugs.
- •25. The following are prohibited during AN0025 therapy and therefore render patients ineligible for randomisation unless these can be switched to alternative medication prior to trial drug dosing:
- •25.1. Non-steroidal anti-inflammatory drugs (NSAIDs)
- •25.2. Aspirin at doses of higher than 325 mg daily
- •25.3. Angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs)
- •25.4. Uridine’5 diphospho-glucuronosyl transferase (UGT) inducers or inhibitors (atazanavir, probenecid, valproic acid, mefenamic acid, quinidine)
- •25.5. Anticoagulation with anti Xa agents (i.e.:Novel oral anticoagulants (NOACs): apixaban, rivaroxaban): Low Molecular Weight Heparin (LMWH) is the preferred form of initial anticoagulation. However, if, in the assessment of the investigator, changing to a NOAC is considered appropriate, then this is acceptable assuming the thrombotic event is medically controlled.
- •26. We recommend that patients DO NOT receive concomitant capecitabine and warfarin as the disturba
研究者
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