ISRCTN24855462已完成2 期
A phase II randomised feasibility study of chemoresection or surgical management in low risk non muscle invasive bladder cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
研究概览
简要总结
2016 Other publications in https://doi.org/10.1016/j.ejso.2016.07.104 recruitment aids 2017 Other publications in https://doi.org/10.1186/s13063-017-1902-y recruitment aids 2018 Results article in https://doi.org/10.1016/S1569-9056(18)31571-9 results 2018 Results article in https://doi.org/10.1016/j.juro.2018.02.3000 results 2019 Results article in https://doi.org/10.1016/S1569-9056(19)30560-3 12-month results 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32124514 results
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 29/03/2017:
- •1. Written informed consent
- •2. NMIBC recurrence following original diagnosis of low risk NMIBC (defined as Ta G1 or Ta G2 (Ta low grade) with a risk of recurrence score of =6 using EORTC risk tables).
- •3. Histologically confirmed TCC at original diagnosis
- •4. Aged 16 or over
- •5. Satisfactory pre-treatment haematology values haemoglobin > 100 g/L and serum creatinine < 1.5xULN
- •6. Negative pregnancy test for women of child-bearing potential
- •Previous inclusion criteria from 12/10/2016 to 29/03/2017:
- •1. Written informed consent
- •2. NMIBC recurrence following original diagnosis of low risk NMIBC (defined as Ta G1 or Ta G2 (Ta low grade) with a risk of recurrence score of =5 using EORTC risk tables).
- •3. Histologically confirmed TCC at original diagnosis
- •4. Aged 16 or over
- •5. Satisfactory pre-treatment haematology values haemoglobin > 100 g/L and serum creatinine < 1.5xULN
- •6. Negative pregnancy test for women of child-bearing potential
- •Original inclusion criteria:
- •1. Written informed consent
- •2. NMIBC recurrence following original diagnosis of low risk NMIBC (defined as Ta G1 or Ta G2 NMIBC with a risk of recurrence score of <=5 using EORTC risk tables)
- •3. Histologically confirmed TCC at original and any subsequent diagnoses
- •4. Aged 16 or over
- •5. Satisfactory pre-treatment haematology values Hb > 100 g/L and serum creatinine < 1.5xULN
- •6. Negative pregnancy test for women of child-bearing potential
排除标准
- •Current exclusion criteria as of 29/03/2017:
- •1. Any history of: grade 3/high grade or =T1 transitional cell carcinoma, concomitant carcinoma in situ, more than 7 tumours at one diagnosis or more than 1 recurrence per year since initial diagnosis or in the past five years, whichever is shorter
- •2. Any history of histologically confirmed non-TCC bladder cancer
- •3. Trial entry recurrence identified within 11.5 months of the date of the original diagnosis
- •4. Any prior treatment of the trial entry recurrence (including biopsy)
- •5. Previous MMC chemotherapy other than a single instillation at diagnostic surgery
- •6. Known allergy to MMC
- •7. Carcinoma involving the prostatic urethra or upper urinary tract (participants should have had imaging of the upper urinary tract within 2 years prior to randomisation)
- •8. Known or suspected reduced bladder capacity (<100ml)
- •9. Significant bleeding disorder
- •10. Female patients who are breast-feeding or are of childbearing potential and unwilling or unable to use adequate non-hormonal contraception. Male patients should also use contraception if sexually active.
- •11. Active or intractable urinary tract infection
- •12. Urethral stricture or anything impeding the insertion of a catheter
- •13. Large narrow neck diverticula
- •14. Significant urinary incontinence
- •15. Any other conditions that in the Principal Investigator’s opinion would contraindicate protocol treatment
- •16. Unable or unwilling to comply with study procedures or follow up schedule
- •Previous exclusion criteria from 12/10/2016 to 29/03/2017:
- •1. Any history of: grade 3/high grade or T1 transitional cell carcinoma, concomitant carcinoma in situ, more than 7 tumours at one diagnosis or more than 1 recurrence per year since initial diagnosis or in the past five years, whichever is shorter
- •2. Any history of histologically confirmed non-TCC bladder cancer
- •3. Trial entry recurrence identified within 11.5 months of the date of the original diagnosis
- •4. Previous MMC chemotherapy other than a single instillation at diagnostic surgery
- •5. Known allergy to MMC
- •6. Carcinoma involving the prostatic urethra or upper urinary tract (participants should have had imaging of the upper urinary tract within 2 years prior to randomisation)
- •7. Known or suspected reduced bladder capacity (<100ml)
- •8. Significant bleeding disorder
- •9. Female patients who are breast-feeding or are of childbearing potential and unwilling or unable to use adequate non-hormonal contraception. Male patients should also use contraception if sexually active
- •10. Active or intractable urinary tract infection
- •11. Urethral stricture or anything impeding the insertion of a catheter
- •12. Large narrow neck diverticula
- •13. Significant urinary incontinence
- •14. Any other conditions that in the Principal Investigator’s opinion would contraindicate protocol treatment
- •15. Unable or unwilling to comply with study procedures or follow up schedule
- •Original exclusion criteria:
研究者
相似试验
进行中（未招募）
1 期
Investigating Bladder Chemotherapy Instead of Surgery for Low Risk Bladder Cancer (CALIBER)EUCTR2013-005095-18-GBThe Institute of Cancer Research89
已完成
2 期
Sequential schedule of platinum then paclitaxel-based chemotherapy for women with epithelial non-mucinous advanced inoperable peritoneal malignancyOvarian cancerAdvanced, inoperable ovarian cancer (epithelial non-mucinous advanced inoperable peritoneal malignancy)CancerISRCTN24742183niversity of Warwick (UK)88
已完成
2 期
A Study to Examine the Effectiveness of Aspirin and/or Vitamin D3 to Prevent Prostate Cancer ProgressionProstate CancerNCT03103152Queen Mary University of London104
进行中（未招募）
不适用
Surgery alone In low rectal cancerRectal cancerCancerISRCTN02406823Morriston Hospital (UK)3
招募中
2 期
Chemo-immunotherapy, Hypo-fractionated RT and Maintenance Immunotherapy for Stage III NSCLC.NSCLC, Stage IIINCT05128630Fondazione IRCCS Policlinico San Matteo di Pavia45