ISRCTN10052456已完成2 期
A Phase II study of neoadjuvant chemotherapy given before short course of preoperative radiotherapy (SCPRT) as treatment for patients with MRI-staged operable rectal cancer at high risk of metastatic relapse
Cardiff University (UK)0 个研究点目标入组 62 人开始时间: 2012年5月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
研究概览
简要总结
2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30116024 results (added 11/04/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patient 18 years old or older
- •2. Tumour biopsy with histopathological confirmation of rectal adenocarcinoma
- •3. Inferior aspect of disease (primary tumour, mesorectal tumour deposits or extra-mural vascular invasion) is not less than 4 cm from anal verge on digital examination and pelvic MRI scan
- •4. Superior aspect of disease is not more superior than the anterior aspect of the S1/S2 interspace on pelvic sagittal MRI scan
- •5. Further MRI defined inclusion criteria include: Mesorectal fascia is not threatened or involved (i.e. tumour is > 1mm from mesorectal fascia) Primary tumour is: T3a-b (mesorectal primary tumour invasion seen = 5 mm beyond muscularis propria) in the presence of either:
- •5.1. Extra-mural vascular invasion or
- •5.2. Mesorectal lymph nodes(s)/tumour deposit(s) with irregular border or mixed signal intensity any T3c (primary tumour invasion seen >5mm beyond muscularis propria)-T4a (invasion of visceral peritoneum for tumours with a component above peritoneal reflection) Low tumours should not involve levator ani (i.e. there is >1 mm gap between tumour and levator ani) or anal sphincters
- •6. No evidence of established metastatic disease on CT of chest and abdomen. (Patients with equivocal lesions determined at MDT are eligible)
- •7. Patient with measurable disease at the baseline visit
- •8. The patient is a candidate for systemic therapy with OxMdG chemotherapy in the opinion of the primary oncologist treating the patient
- •9. ECOG Status: 0-1
- •10. Bloods: Adequate bone marrow, hepatic, renal and metabolic function (assessed within 14 days prior to consent):
- •10.1. Haemoglobin = 9 g/dL, leucocyte count = 3 x 109/L, neutrophil count =1.5 x109/L and platelet count =100 x109/L
- •10.2. Total bilirubin = 1.5 x ULRR, alkaline phosphatase = 5 x ULRR, and serum transaminase (either AST or ALT) =2.5 x ULRR
- •10.3. Estimated creatinine clearance = 50 ml/min (calculated according to Cockroft and Gault). (Confirmed with 24 hour urine creatinine clearance or EDTA if estimated creatinine clearance < 50 ml/min)
- •10.4. Calcium =LLRR
- •11. No known significant impairment of intestinal absorption (e.g. chronic diarrhoea, inflammatory bowel disease)
- •12. Baseline ECG showing no evidence of established or acute ischaemic heart disease (e.g. left bundle branch block, pathological q waves, ST elevation or ST-segment depression) and normal clinical cardiovascular assessment
- •13. Note, a defunctioning colostomy or ileostomy is permitted to relieve impending rectal obstruction or severe local bowel symptoms
- •14. Lower age limit 18 years
排除标准
- •1. Disease threatening the mesorectal fascia (i.e. disease = 1 mm from mesorectal fascia whether this is primary tumour, extra-mural vascular invasion or tumour deposit with irregular border or mixed signal intensity)
- •2. Stage T4b cancer with invasion into adjacent organs or structures
- •3. Enlarged pelvic sidewall (internal iliac) lymph nodes considered to be involved
- •4. Unequivocal evidence of metastatic disease (includes resectable metastases)
- •5. Severe local bowel symptoms of tenesmus, frequency (at least baseline grade 3 diarrhoea) or incontinence that have not been relieved by a defunctioning colostomy/ileostomy.
- •6. Pelvic sepsis
- •7. Metallic colonic/ rectal stent in situ
- •8. Patient who has received previous pelvic radiotherapy
- •9. Patient with an uncontrolled infection
- •10. Pregnant, breast feeding or trying to conceive
- •11. Previous treatment with another investigational antitumoral therapy in the 30 days prior to beginning treatment (including chemotherapy, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloproteinase inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibodies, or other experimental drugs)
- •12. Patients with another previous or current malignant disease which in the judgement of the treating investigator is likely to interfere with treatment or the assessment of response.
- •13. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrollment
- •14. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
- •15. Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment
- •16. Previous malignancies in the preceding five years except for:
- •-In situ cancer of the uterine cervix
- •-Adequately treated basal cell skin carcinoma
- •-Any early stage malignancy
研究者
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