ISRCTN50083238已完成2 期
A multi-centre randomised study of induction chemotherapy followed by capecitabine (+/-nelfinavir) with high or standard dose radiotherapy for locally advanced non-metastatic pancreatic cancer
niversity of Oxford (UK)0 个研究点目标入组 186 人开始时间: 2015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
- 186
研究概览
简要总结
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30717707 protocol (added 09/08/2019) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39059185/ (added 29/07/2024)
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 06/02/2020:
- •1. Aged 18 years or over
- •2. Histologically or cytologically proven carcinoma of the pancreas
- •3. Locally advanced, non-metastatic inoperable disease as per NCCN criteria. The following types of interventions are allowed:
- •3.1. Palliative bypass procedure
- •3.2. Common bile duct stenting
- •4. Primary pancreatic lesion 6 cm or less in diameter (taken from scan results)
- •5. World Health Organisation PS 0-1
- •6. Adequate haematological function: neutrophils at least 1.5 x 109/L and platelets at least 100 x 109/L 7. Adequate liver function tests:
- •7.1. Serum bilirubin less than or equal to 1.5 x ULN. In participants who have had a recent biliary drain and whose bilirubin is improving, a value of less than or equal to 3 x ULN is acceptable, however treatment should not start unless Bilirubin is less than or equal to 1.5 x ULN.
- •7.2. AST and/or ALT less than or equal to 3 x ULN.
- •8. Adequate renal function (GFR at least 40ml/min) (using a validated creatinine clearance calculation (e.g. Cockcroft & -Gault , Wright formula, or as per local standard).
- •9. Written informed consent obtained
- •10. Women of child-bearing potential must have negative serum or urine pregnancy test within 14 days prior to registration and must agree to use an adequate contraception method (defined as barrier methods in conjunction with spermicide, approved contraceptive implants, long-term injectable contraception or intrauterine hormonal devices) during GEMABX treatment and for 6 months after the last administration of GEMABX, as well as during chemoradiotherapy and for 6 months after completion of all treatment.
- •11. Male patients must be surgically sterile or must agree to use a condom during GEMABX treatment and for 6 months after last administration of GEMABX, and to use a condom during chemoradiotherapy and for three months after completion of chemoradiotherapy or, whichever date comes last.
- •Previous inclusion criteria:
- •1. Aged 18 years or over
- •2. Histologically or cytologically proven carcinoma of the pancreas
- •3. Locally advanced, non-metastatic inoperable disease as per NCCN criteria. The following types of interventions are allowed:
- •3.1.Palliative bypass procedure
- •3.2. Common bile duct stenting
- •4. Primary pancreatic lesion 6 cm or less in diameter (taken from scan results)
- •5. WHO PS 0-1
- •6. Adequate haematological function: neutrophils at least 1.5 x 109/L, platelets at least 100 x 109/L and haemoglobin at least 100g/L
- •7. Adequate liver function tests:
- •7.1.Serum bilirubin less than or equal to 1.5 x ULN. In participants who have had a recent biliary drain and whose bilirubin is improving, a value of less than or equal to 3 x ULN is acceptable, however treatment should not start unless Bilirubin is less than or equal to 1.5 x ULN.
- •7.2. AST and/or ALT less than or equal to 3 x ULN.
- •8. Adequate renal function (GFR at least 50ml/min)
- •9. Written informed consent obtained
- •10. Women of child-bearing potential must have negative serum or urine pregnancy test within 14 days prior to registration, must agree to use a highly effective contraception method during GEMABX treatment and for 30 days after last administration of GEMABX and to use an acceptable contraception method during chemoradiotherapy and for 6 months after completion of all treatment
- •11. Male patients must be surgically sterile or must agree to use a condom during GEMABX treatment and for 90 days after last administration of GEMABX, and to use a condom during che
排除标准
- •Current exclusion criteria as of 06/02/2020:
- •1. Primary resectable cancer of the pancreas.
- •2. Distant metastases
- •3. Pregnant or breastfeeding patients.
- •4. Any evidence of severe uncontrolled systemic diseases including uncontrolled coronary artery disease, myocardial infarction or stroke within the last 6 months, any major systemic or psychiatric comorbidities or any other considerations that the PI judges might impact on patient safety or protocol compliance and achievement of the study aims.
- •5. Previous malignancies in the preceding 3 years except for:
- •5.1. In situ cancer of the uterine cervix
- •5.2. Adequately treated basal cell skin carcinoma
- •5.3. Adequately treated early-stage non-pancreatic malignancy in complete remission for at least three years
- •6. Renal abnormalities including adult polycystic kidney disease or hydronephrosis or ipsilateral single kidney (i.e. functioning right kidney for head tumours; left kidney for tail tumours) that may preclude upper abdominal radiotherapy without damaging functional kidneys.
- •7. Previous RT to upper abdomen
- •8. Recurrent cancer following definitive pancreatic surgery
- •9. Lymphoma or neuroendocrine tumours of the pancreas
- •10. Known haemophilia A and B, chronic hepatitis type B or C.
- •11. Other experimental treatment 6 weeks or less prior to registration into this study (including chemotherapy and immunotherapy).
- •12. Known hypersensitivity to any of the IMPs or any of their excipients.
- •13. Known dihydropyrimidine dehydrogenase (DPD) deficiency
- •14. Known galactose intolerance, Lapplactose deficiency or glucosegalactose malabsorption
- •15. History of severe unexpected reaction to fluoropyrimidine therapies
- •16. If the following concomitant medications cannot be discontinued temporarily during the CRT phase then the patients cannot enter the trial, as they interact with capecitabine:
- •16.1. Sorivudine and analogues e.g. brivudine
- •16.2. Methotrexate.
- •16.3. Allopurinol and dipyridamole
- •17. Use of prohibited concomitant medications listed in section 7.3.4. (Note that temporary discontinuation during nelfinavir treatment is not acceptable) these cannot be temporarily discontinued. Please refer to the following website for full information: http://www.viivhealthcare.com/our-medicines/viracept.aspx
- •18. Known HIV-positive disease (but routine screening for HIV is not required)
- •Previous exclusion criteria:
- •1. Primary resectable cancer of the pancreas.
- •2. Distant metastases
- •3. Pregnant or breastfeeding patients.
- •4. Any evidence of severe uncontrolled systemic diseases including uncontrolled coronary artery disease, myocardial infarction or stroke within the last 6 months, any major systemic or psychiatric comorbidities or any other considerations that the PI judges might impact on patient safety or protocol compliance and achievement of the study aims.
- •5. Previous malignancies in the preceding 3 years except for:
- •5.1. In situ cancer of the uterine cervix
- •5.2. Adequately treated basal cell skin carcinoma
- •5.3. Adequately treated early stage non-pancreatic malignancy in complete remission for at least 3 years
- •6. Renal abnormalities including adult polycystic kidney disease or hydronephrosis or ipsilateral single kidney (i.e. functioning right kidney for head tumours; left kidney for tail tumours) that may preclude upper abdominal radiotherapy without damaging functional kidneys.
- •7. Previous RT to upper abdomen
- •8. Recurrent cancer following definitive pancreatic surgery
- •9. Lymphoma or neuroendocrine tumours o
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