None listed
Conditions
Brief summary
To assess in a formal protocol whether or not an intrapatient dose-escalation strategy for carboplatin can produce an improved outcome over flat dosing.
Interventions
Chemotherapy: Carboplatin given over 6 cycles, 3 weekly.
Sponsors
SGCTG (and also investigator initiated)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Histologically confirmed epithelial ovarian carcinoma, or primary fallopian tube carcinoma or peritoneal carcinomatosis (ovarian-type), considered unsuitable or unwilling for treatment with platinum-taxane combination therapy; FIGO stages Ic-IV with or without successful cytoreductive surgery at staging laparotomy (Stage Ic patients will be limited to those with malignant cells in ascitic fluid/peritoneal washings, tumour on the surface of the ovary, or pre-operative capsule rupture); Intention to treat patient within 8 weeks of initial surgery.
Exclusion criteria
ECOG performance status > 3; Prior treatment with chemotherapy or radiotherapy; Inadequate bone marrow function, renal function or liver function; Concurrent severe and/or uncontrolled co-morbid medical condition; Patients with mixed mesodermal tumours, borderline ovarian tumours or tumours termed "possibly malignant"; Adenocarcinoma of unknown origin, if histologically shown to be mucin-secreting cancer; History of previous malignancy within the previous 5 years or concurrent malignancy (e.g. co-existing endometrial cancer); Pregnant or lactating women; Symptomatic peripheral neuropathy > NCI-CTC grade II.
Outcome results
None listed