ISRCTN06473203已完成2 期
A randomised multi-stage, phase II/III trial of standard first-line therapy (sunitinib or pazopanib) comparing temporary cessation with allowing continuation in the treatment of locally advanced and/or metastatic renal cancer
niversity of Leeds (UK)0 个研究点目标入组 920 人开始时间: 2011年4月15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
- 920
研究概览
简要总结
2012 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/23241439 protocol 2021 Abstract results in https://dx.doi.org/10.1016/annonc/annonc741 (added 30/09/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36796394/ (added 17/02/2023)
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 31/10/2014:
- •1. Male or female aged = 18 years old
- •2. Histological confirmation of a component of clear cell renal cell cancer
- •3. Inoperable loco-regional or metastatic disease
- •4. No prior systemic therapy for advanced disease (inoperable loco-regional and/or metastatic disease)
- •4.1 Allowed situation: previous treatment in the SORCE study providing on placebo arm and not active sorafenib arms
- •5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •6. Uni-dimensionally measurable disease (RECIST criteria
- •7. Full blood count:
- •7.1 Haemoglobin (Hb) = 9 g/dl
- •7.2. Absolute Neutrophil Count (ANC) = 1 x 10 9/l
- •7.3. Platelets = 80 x 10 9/l
- •8. Renal biochemistry: measured or calculated GFR = 30 ml/min
- •9. Hepatobiliary function
- •9.1. Aspartate transaminase (AST) or alanine transaminase (ALT) = 2.5 x ULN
- •9.2. Bilirubin (BR) = 1.5 x ULN, or in patients with Gilbert?s syndrome BR = x3 x ULN and direct BR = 35%
- •10. Provided written informed consent prior to any trial-specific procedures
- •11. Able and willing to comply with the terms of the protocol including:
- •11.1. Commencement of sunitinib or pazopanib within 5 (actual not working) days of randomisation
- •11.2. Temporarily stopping sunitinib or pazopanib if randomised to the DFIS arm
- •11.3. Capable of oral self-medication
- •11.4 randomisation within 42 days of the baseline CT scan
- •11.5. Capable of reporting toxicity and completing quality of life (QoL) and medical resource utilisation (MRU) / Health Economics questionnaires
- •12. If female and of child-bearing potential, must:
- •12.1. Have a negative pregnancy test within 72 hours prior to randomisation, and not be breast-feeding
- •12.2. Agree to use adequate, medically approved, contraceptive precautions (oral or barrier contraceptive under the supervision of a General Practitioner or Family Planning Clinic) during, and for 30 days after the last dose of sunitinib or pazopanib
- •13. If male with a partner of child bearing potential, must agree to use adequate, medically approved, contraceptive precautions (oral or barrier contraceptive under the supervision of a General Practitioner or Family Planning Clinic) during, and for 30 days after the last dose of sunitinib or pazopanib
- •14. Requirement to start first-line therapy with either sunitinib or pazopanib and decision already made as to which TKI to be used according to local standard practice
- •15. Allowed situations include:
- •15.1. Primary renal cancer in-situ or previous nephrectomy
- •15.2. Previous brain metastases treated with complete surgical resection, Stereotactic Brain Radiation Therapy (SBRT) or gamma knife with no subsequent evidence of progression (patients treated with whole brain radiotherapy are not eligible)
- •15.3. Previous radiotherapy and/or previous/ongoing bisphosphonates or bone anti-resorptive drugs for the treatment of symptomatic bony metastasis. Care should be taken to follow dental guidelines for the anti-bone resoptive drug.
- •Inclusion criteria from 15/05/2013 to 31/10/2014:
- •1. Male or female aged = 18 years old
- •2. Histological confirmation of predominantly clear cell renal cell cancer
- •3. Inoperable loco-regional or metastatic disease
- •4. No prior systemic therapy for advanced disease (inoperable loco-regional and/or metastatic disease)
- •5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •6. Uni-dimensionally measurable disease (RECIST criteria, see Appendix 3)
- •7. Full blood count:
- •7.1 Haemoglobin (Hb)
排除标准
- •Current exclusion criteria as of 31/10/2014:
- •1. Pulmonary or mediastinal disease causing obstruction or clinically significant bleeding/haemoptysis
- •2. Patients with an estimated life expectancy of <6 months
- •3. Known contraindications to the particular TKI to be used (i.e. sunitinib or pazopanib)
- •4. Any previous treatment with sunitinib, pazopanib or other tyrosine kinase inhibitor (including in the adjuvant setting)
- •5. Untreated brain metastases
- •6. Any concurrent or previous other invasive cancer that could confuse diagnosis or endpoints
- •6.1. Allowed situations include (but not limited to): non-melanomatous skin cancer or superficial bladder cancer; for all other cases please discuss with Clinical Trials Research Unit (CTRU))
- •7. Hypersensitivity to the particular TKI to be used (i.e. sunitinib or pazopanib)
- •8. Any concomitant medication or substances forming part of local ongoing care known to significantly affect, or have the potential to significantly affect, the activity or pharmacokinetics of the particular TKI to be used (i.e. sunitinib or pazopanib)
- •9. Poorly controlled hypertension despite maximal medical therapy
- •10. Any other serious medical or psychiatric condition which in the opinion of the investigator could affect participation in the STAR trial, including gastro-intestinal abnormalities limiting effectiveness of orally administrated drugs, uncontrolled infections, current or recent history of clinically significant cardiovascular disease, significant haemorrhage or gastrointestinal perforation or fistula which, in the opinion of the local investigator, would render the patient unsuitable for standard sunitinib or pazopanib therapy
- •Exclusion criteria from 15/05/2013 to 31/10/2014:
- •1. Pulmonary or mediastinal disease causing obstruction or bleeding/haemoptysis
- •2. Patients with an estimated life expectancy of <6 months
- •3. Known contraindications to sunitinib or pazopanib
- •4. No previous treatment with sunitinib, pazopanib or other tyrosine kinase inhibitor (including in the adjuvant setting)
- •5. Untreated brain metastases
- •6. Any concurrent or previous other invasive cancer that could confuse diagnosis (non-melanomatous skin cancer or superficial bladder cancer acceptable, for all other cases please discuss with Clinical Trials Research Unit (CTRU))
- •7. Hypersensitivity to sunitinib or pazopanib
- •8. Any concomitant medication or substances forming part of local ongoing care known to significantly affect, or have the potential to significantly affect, the activity or pharmacokinetics of sunitinib or pazopanib (see section 10.2 for further information on concomitant medications)
- •9. Poorly controlled hypertension despite maximal medical therapy
- •10. Any other serious medical or psychiatric condition which in the opinion of the investigator could affect participation in the STAR trial, including gastro-intestinal abnormalities limiting effectiveness of orally administrated drugs, uncontrolled infections, current or recent history of clinically significant cardiovascular disease, significant haemorrhage or gastrointestinal perforation or fistula which, in the opinion of the local investigator, would render the patient unsuitable for standard sunitinib or pazopanib therapy
- •Exclusion criteria from time of registration until 15/05/2013:
- •1. Pulmonary or mediastinal disease causing obstruction or bleeding/haemoptysis
- •2. Patients with an estimated life expectancy of <6 months
- •3. Known contraindications to sunitinib
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