CompletedPhase 3ACTRN12605000694617

SCOTROC 4

SCOTROC 4: A Prospective, Multicentre, Randomised Trial of Carboplatin Flat Dosing Vs Intrapatient Dose Escalation in First Line Chemotherapy of Ovarian, Fallopian Tube and Primary Peritoneal Cancers, to improve progression-free survival.

Sponsor

SGCTG (and also investigator initiated)

Enrollment

1,300 participants

Start Date

Jan 24, 2006

Study Type

Interventional

Conditions

Ovarian, Fallopian Tube and Primary Peritoneal Cancers

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.

Eligibility

Sex: FemalesMin Age: 18 Yearss

Inclusion Criteria1

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 Criteria1

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.

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Interventions

Chemotherapy: Carboplatin given over 6 cycles, 3 weekly.

Locations(1)

New Zealand

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ACTRN12605000694617