Rak wątroby: badanie fazy III leku etoposide i doxorubicin hydrochloride

Kryteria włączenia kto może wziąć udział (36)

1. General criteria • Clinical diagnosis of HB or histologically defined diagnosis of HB or HCC. Histological confirmation of HB is required except in emergency situations where: a) The patient meets all other eligibility criteria, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy. b) There is anatomic or mechanical compromise of critical organ function by tumour (e.g., respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc.). c) Uncorrectable coagulopathy.
2. Group A2 - Treatment arm • Central pathology review confirming non-WDF histology.
3. • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2
4. • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age
5. Group B • Patient meets Low Risk definition according to CHIC Guidelines
6. • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2
7. • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age
8. Group C • Patient meets Intermediate Risk definition according to CHIC Guidelines
9. • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2
10. • Adequate cardiac function determined by: o Shortening fraction ≥28% by local assessment method o OR Ejection fraction ≥47% by local assessment method
11. • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age
12. General criteria • Age ≤30 years
13. Group D • Patient meets High Risk definition according to CHIC Guidelines
14. • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2
15. • Adequate cardiac function determined by: o Shortening fraction ≥28% by local assessment method o OR Ejection fraction ≥47% by local assessment method
16. • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age
17. Group E - At diagnosis: • Patient has been diagnosed with HCC
18. • Tumour has been resected with negative margins Group E1
19. • HCC secondary to underlying liver disease
20. Group E2 • HCC de novo, including fibrolamellar
21. • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2
22. • Adequate cardiac function determined by: o Shortening fraction ≥28% by local assessment method o OR Ejection fraction ≥47% by local assessment method
23. General criteria • Written informed consent for trial entry
24. • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age
25. Group F • Patient diagnosed with HCC
26. • Tumour locally assessed as un-resectable, or metastatic HCC disease
27. • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2
28. • Adequate cardiac function determined by: o Shortening fraction ≥28% by local assessment method o OR Ejection fraction ≥47% by local assessment method
29. • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age o Qt/QTc interval =/<450msec for males, =/<470msec for females
30. For Allocation/Randomisation to Treatment Group: All Groups • Written Informed Consent for trial treatment participation
31. For Allocation/Randomisation to Treatment Group: All Groups • Patient assessed as fit to receive group specific treatment
32. For Allocation/Randomisation to Treatment Group: All Groups • For females of child-bearing potential, a negative pregnancy test prior to trial entry is required. Any patient who is of reproductive age must agree to use adequate contraception for the duration of the trial.
33. Group A (no treatment arm) - At diagnosis: • Resected Tumour.
34. Group A1 – No treatment arm • Patient meets Very Low Risk definition according to CHIC guidelines.
35. Group A1 – No treatment arm • Central pathology review confirming WDF histology.
36. Groups B, C & D - Real time review required if age>8 and/or AFP<100 – confirm HB diagnosis