Systemic Therapy and Chemoradiation in Advanced Localised Pancreatic Cancer - 2
Last updated on April 2022Recruitment
- Recruitment Status
- Unknown status
Inclusion Criteria
- Adequate haematological function: neutrophils ≥1.5 x 109/L, platelets ≥100 x 109/L and haemoglobin ≥100g/L
- Written informed consent obtained
- Adequate renal function (GFR ≥ 50ml/min (Cockcroft & Gault - APPENDIX 3))
- ...
- Adequate haematological function: neutrophils ≥1.5 x 109/L, platelets ≥100 x 109/L and haemoglobin ≥100g/L
- Written informed consent obtained
- Adequate renal function (GFR ≥ 50ml/min (Cockcroft & Gault - APPENDIX 3))
- 1. Aged 18 years or over
- 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.
- Serum bilirubin ≤1.5 x ULN. In participants who have had a recent biliary drain and whose bilirubin is improving, a value of ≤3 x ULN is acceptable, however treatment should not start unless Bilirubin is ≤1.5 x ULN.
- Palliative bypass procedure
- Primary pancreatic lesion 6 cm or less in diameter (taken from scan results)
- 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 chemoradiotherapy and for three months after completion of chemoradiotherapy.
- Histologically or cytologically proven carcinoma of the pancreas
- WHO PS 0-1 (APPENDIX 1)
- Common bile duct stenting
- AST and/or ALT ≤ 3 x ULN.
Exclusion Criteria
- Sorivudine and analogues e.g. brivudine
- History of severe unexpected reaction to fluoropyrimidine therapies
- Pregnant or breast-feeding patients.
- ...
- Sorivudine and analogues e.g. brivudine
- History of severe unexpected reaction to fluoropyrimidine therapies
- Pregnant or breast-feeding patients.
- Methotrexate.
- Adequately treated basal cell skin carcinoma
- Known HIV positive disease (but routine screening for HIV is not required)
- Distant metastases
- 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.
- Known haemophilia A and B, chronic hepatitis type B or C.
- Allopurinol and dipyridamole
- In situ cancer of the uterine cervix
- 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 co-morbidities or any other considerations that the PI judges might impact on patient safety or protocol compliance and achievement of the study aims.
- Other experimental treatment 6 weeks or less prior to registration into this study (including chemothera¬py and immunotherapy).
- Primary resectable cancer of the pancreas.
- Lymphoma or neuroendocrine tumours of the pancreas
- Recurrent cancer following definitive pancreatic surgery
- Known galactose intolerance, Lapp-lactose deficiency or glucose-galactose malabsorption
- Known hypersensitivity to any of the IMPs or any of their excipients.
- Previous RT to upper abdomen
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Adequately treated early stage non-pancreatic malignancy in complete remission for at least 3 years
Summary
- Conditions
- Pancreatic Neoplasms (Locally Advanced Non-metastatic)
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Inclusion Criteria
- Adequate haematological function: neutrophils ≥1.5 x 109/L, platelets ≥100 x 109/L and haemoglobin ≥100g/L
- Written informed consent obtained
- Adequate renal function (GFR ≥ 50ml/min (Cockcroft & Gault - APPENDIX 3))
- ...
- Adequate haematological function: neutrophils ≥1.5 x 109/L, platelets ≥100 x 109/L and haemoglobin ≥100g/L
- Written informed consent obtained
- Adequate renal function (GFR ≥ 50ml/min (Cockcroft & Gault - APPENDIX 3))
- 1. Aged 18 years or over
- 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.
- Serum bilirubin ≤1.5 x ULN. In participants who have had a recent biliary drain and whose bilirubin is improving, a value of ≤3 x ULN is acceptable, however treatment should not start unless Bilirubin is ≤1.5 x ULN.
- Palliative bypass procedure
- Primary pancreatic lesion 6 cm or less in diameter (taken from scan results)
- 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 chemoradiotherapy and for three months after completion of chemoradiotherapy.
- Histologically or cytologically proven carcinoma of the pancreas
- WHO PS 0-1 (APPENDIX 1)
- Common bile duct stenting
- AST and/or ALT ≤ 3 x ULN.
Exclusion Criteria
- Sorivudine and analogues e.g. brivudine
- History of severe unexpected reaction to fluoropyrimidine therapies
- Pregnant or breast-feeding patients.
- ...
- Sorivudine and analogues e.g. brivudine
- History of severe unexpected reaction to fluoropyrimidine therapies
- Pregnant or breast-feeding patients.
- Methotrexate.
- Adequately treated basal cell skin carcinoma
- Known HIV positive disease (but routine screening for HIV is not required)
- Distant metastases
- 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.
- Known haemophilia A and B, chronic hepatitis type B or C.
- Allopurinol and dipyridamole
- In situ cancer of the uterine cervix
- 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 co-morbidities or any other considerations that the PI judges might impact on patient safety or protocol compliance and achievement of the study aims.
- Other experimental treatment 6 weeks or less prior to registration into this study (including chemothera¬py and immunotherapy).
- Primary resectable cancer of the pancreas.
- Lymphoma or neuroendocrine tumours of the pancreas
- Recurrent cancer following definitive pancreatic surgery
- Known galactose intolerance, Lapp-lactose deficiency or glucose-galactose malabsorption
- Known hypersensitivity to any of the IMPs or any of their excipients.
- Previous RT to upper abdomen
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Adequately treated early stage non-pancreatic malignancy in complete remission for at least 3 years
Tracking Information
- NCT #
- NCT02024009
- Collaborators
- Celgene
- Cancer Research UK
- Investigators
- Principal Investigator: Somnath Mukherjee, MD, FRCP, FRCR somnath.mukherjee@oncology.ox.ac.uk
- Somnath Mukherjee, MD, FRCP, FRCR somnath.mukherjee@oncology.ox.ac.uk
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