livercancer Livertumor
Conditions
Interventions
Group A: No intervention.
Group B1: Randomisation between 4 additional cycles versus 2 additional cycles
cisplatin.
Group B2: No intervention.
Group C: Randomisation between SIOPEL-3HR versus C5VD ve
Sponsors
University of Birmingham
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: For Trial Entry: • Clinical diagnosis of HB or histologically defined diagnosis of HB or HCC. • Age
Exclusion criteria
Exclusion criteria: • Any previous chemotherapy or currently receiving anti-cancer agents • Recurrent disease • Previously received a solid organ transplant • Uncontrolled infection • Unable to follow the protocol for any reason • Second malignancy • Pregnant or breastfeeding womenGroup specific exclusion criteria All Groups: -Hypersensitivity to any medicines used in allocated group. Group C: -Patients who have known deficiency of dihydropyrimidine dehydrogenase (DPD) Group D: -Chronic inflammatory bowel disease and/or bowel obstruction -Concomitant use with St John*s Wort which cannot be stopped prior to start of trial treatment Group F: -Low K, Mg or Ca which remains uncorrected by electrolyte supplementation -Peripheral Sensory Neuropathy with functional impairment -Personal or family history of congenital long QT syndrome -QT/QTc interval >450msec for males and >470msec for females -Patients who are unable to swallow tablets where an oral suspension is not available or not approved e Laag Risic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Group B1: Event free survival -Group C: Event free survival -Group D2/D3: Event free survival -Group F: Respons on chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| -Group A1: Event-free survival, overall survival, adherence to surgical guidelines. -Group A2: Event-free survival, overall survival, chemotherapy related toxicity, hearing loss, adherence to surgical guidelines. -Group B1: Event-free survival, overall survival, toxicity, chemotherapy-related toxicity, best respons, hearing loss, adherence to surgical guidelines. -Group B2: Event-free survival, failure-free survival, overall survival, chemotherapy related toxicity, respons, surgical resectability, hearing loss, adherence to surgical guidelines. -Group C: Event-free survival, failure-free survival, overall survival, toxicity, chemotherapy related toxicity, respons, hearing loss, adherence to surgical guidelines. -Group D1: Event-free survival, failure- free survival, overall survival, chemotherapy related toxicity, respons, hearing loss, adherence to surgical guidelines. -Group D2/D3: Event-free survival, failure-free survival, overall survival, toxicity, chemotherapy related toxicity, respons, surgical resectability, hearing loss, adherence to surgical guideliines. -Group E1: Event-free survival, overall survival, resectability. -Group E2: Event-free survival, overall survival, chemotherapy related toxicity, hearing loss. -Group F: Respons, failure-free survival, overall survival toxicity, chemotherapy related toxicity, surgical resectability, hearing loss. | — |
Countries
Netherlands
Outcome results
None listed