ISRCTN02406823进行中（未招募）未知
Multicentre randomised phase II feasibility study evaluating neoadjuvant chemoradiotherapy plus surgery with Surgery Alone In LOw Rectal cancer
Morriston Hospital (UK)0 个研究点目标入组 3 人开始时间: 2013年6月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3
研究概览
简要总结
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27872117
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 24/02/2014:
- •1. Age 18 years and older
- •2. Histologically confirmed rectal adenocarcinoma
- •3. Radiologically measurable or clinically evaluable disease
- •4. Low rectal cancer, defined as within 6cm of anal verge on rigid sigmoidoscopy and considered to require abdominoperineal resection (APR) rather than restorative procedure (anterior resection)
- •5. Potentially resectable local disease by surgery alone with clear CRM (where visible on MRI) or predicted surgical resection margin (where CRM absent in distal tumours) as determined by MRI
- •6. Clinical disease stage (MRI+/- endorectal US):
- •6.1. cT3a/b (<10 mm) disease within 6 cm of anal verge; or for tumours at/below level of puborectalis
- •6.2. through full thickness of muscularis propria (cT2) disease at level of puborectalis
- •7. Involvement of internal anal sphincter or intersphincteric space without extension into adjacent levator plate,
- •8. TanyN1 (resectable)
- •9. WHO Performance status 0, 1, or 2
- •10. Neutrophil count = 1,500/mm³
- •11. Platelets = 100,000/mm³
- •12. Haemoglobin > 80 g/L
- •13. Total bilirubin = 1.5x ULN
- •14. AST & ALT = 3 x ULN
- •15. Creatinine = 1.5 x ULN
- •16. Negative pregnancy test
- •17. Patient of child-bearing potential willing to employ adequate contraception
- •18. Willing to return to enrolling medical site for all study assessments
- •19. No other invasive malignancy = 5 years prior to registration
- •20. No concurrent disease that, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study
- •21. No chemotherapy within 5 years prior to registration (hormonal therapy is allowable if the disease-free interval is = 5 years)
- •22. No prior pelvic radiation
- •Previous inclusion criteria:
- •1. Aged 18 years and older
- •2. Pathologically confirmed rectal adenocarcinoma
- •3. Radiologically measurable or clinically evaluable disease
- •4. Low rectal cancer, defined as within 6cm of anal verge on rigid sigmoidoscopy and considered to require abdominoperineal excision (APER)
- •5. Potentially resectable local disease by surgery alone with clear margins as determined by MRI
- •6. Clinical disease stage (MRI+/- endorectal US):
- •6.1. T3a/b/c disease
- •6.2. T4 disease with sole involvement of internal/external sphincter/ adjacent (<10mm) levator plate or posterior wall of vagina
- •6.3. TanyN1 (resectable)
- •7. WHO Performance status 0, 1, or 2
- •8. Neutrophil count = 1,500/mm³
- •9. Platelets = 100,000/mm³
- •10. Haemoglobin > 8.0 g/dL
- •11. Total bilirubin = 1.5x ULN
- •12. AST & ALT = 3 x ULN
- •13. Creatinine = 1.5 x ULN
- •14. Negative pregnancy test
- •15. Patient of child-bearing potential willing to employ adequate contraception
- •16. Willing to return to enrolling medical site for all study assessments
- •17. No other invasive maligna
排除标准
- •Current exclusion criteria as of 24/02/2014:
- •1. Preoperative chemoradiotherapy absolutely indicated, for example MRI-predicted CRM/MRF involvement (<1 mm) by primary or nodal disease, or otherwise unresectable disease;
- •2. cT3c or d (>10 mm);
- •3. Adjacent organ involvement at entry (prostate, seminal vesicles, sacrum or coccyx; T4b) requiring multivisceral resection/ pelvic exenteration;
- •4. For low tumours at level of puborectalis sling: lateral extension of tumour into external anal sphincter or beyond puborectalis sling into levator plate;
- •5. Extramural vascular invasion on MRI;
- •6. Early stage rectal cancer (T1, T2 above level of levators) unless node positive;
- •7. Locally perforated disease (T4a);
- •8. Fistulating disease (vagina, perianal skin, adjacent hollow organ);
- •9. Disease extrusion through anus;
- •10. cN2 disease;
- •11. Lateral pelvic/ para-aortic lymphadenopathy (>10 mm by size criteria);
- •12. Unresectable metastatic disease (M1) (potentially resectable disease permitted);
- •13. Previous pelvic radiotherapy;
- •14. Unfit for major surgery;
- •15. Pregnancy;
- •16. Contraindication to MRI (metal implants etc);
- •17. Contraindication to 5-FU based chemotherapy (including drug interactions);
- •18. WHO Performance Status 3 or 4;
- •19. Unwilling to consent to trial participation
- •Previous exclusion criteria:
- •1. Preoperative chemoradiotherapy absolutely indicated, for example predicted CRM involvement (<2 mm) by primary or nodal disease, or otherwise unresectable disease;
- •2. Adjacent organ involvement (prostate, seminal vesicles, sacrum or coccyx; T4b) requiring multivisceral resection/pelvic exenteration; wide (>10mm) levator involvement
- •3. Early stage rectal cancer (T1, T2) unless node positive
- •4. Locally perforated disease (T4a)
- •5. Disease extrusion through anus
- •6. Lateral pelvic/ paraaortic lymphadenopathy
- •7. Metastatic disease (M1)
- •8. Previous pelvic radiotherapy
- •9. Pregnancy
- •10. Contraindication to 5-FU based chemotherapy
- •11. WHO Performance Status 3 or 4
- •12. Unwilling to consent to trial participation
- •Criteria for Premature Withdrawal
- •1. Withdrawal of consent
- •2. Failure to meet inclusion criteria (delayed)
- •3. Development of irresectable metastatic disease
- •4. Development of irresectable primary tumour after randomisation
- •5. Change in surgical procedure following chemoradiotherapy. In the event of significant tumour regression a sphincter-saving operation (low anterior resection) may be considered more appropriate by the responsible clinician than a sphincter-excising APR procedure.
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