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Phase II trial evaluating the efficacy and safety of physician chosen chemotherapy with hormonal therapy in patients with heavily pretreated advanced ovarian cancer: A multicenter pilot study

Phase II trial evaluating the efficacy and safety of physician chosen chemotherapy with hormonal therapy in patients with heavily pretreated advanced ovarian cancer: A multicenter pilot study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CRIS
Registry ID
KCT0004571
Enrollment
58
Registered
2019-12-20
Start date
2019-10-21
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Receptor status is assessed by immunohistochemistry using recurrent tissues obtained from biopsy as determined by central laboratory. Dominant receptor, which means the receptor that has the hi

Sponsors

Inha University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: - =19 age - Patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer (EOC): including all histologic types -Confirmation of recurrence using biopsy from primary or metastatic tissue -Palliative treatment setting: [(previous progression free or treatment free interval < 6months and 2 prior chemotherapy regimens) or (=3 prior chemotherapy regimens)] -ECOG Performance status 0-2 -Measurable lesion - Estimated life time =6months - Adequate hematologic and end organ function - During clinical trial, women of reproductive age should undergo adequate contraception, and should not perform breast feeding. Moreover, women should have negative pregnancy test performed immediately before clinical trial

Exclusion criteria

Exclusion criteria: -Patients who were diagnosed with other type of primary cancer within 5 years from diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube cancer (EOC): except cervical intraepithelial neoplasm -Cases that investigator decides as inadequate for study -Patient who has not been recovered from recent surgery -Patient having toxicity more than grade 2 of CTCAE originated from previous chemotherapy -Patient receiving immunotherapy or targeted therapy as anticancer therapy -History of venous thromboembolism -Pregnant women or women having possibility of pregnancy -Hypersensitivity for tamoxifen -Patient receiving combined therapy with Anstrozole -Patient having genetic disorders such as galactose intolerance, lapp lactase deficiency or glucose-galactose malaborption -Hypersensitivity for megestrol acetate

Design outcomes

Primary

MeasureTime frame
objective response rate

Secondary

MeasureTime frame
discordance in hormonal receptor expression between tissues obtained from biopsies at enrollment and at time of disease progression;methylation status of hormonal receptors;Adverse events

Countries

Korea, Republic of

Contacts

Public ContactEUNSUN LEE

KGOG(Korea Gynecologic Oncology Group)

eslee@kgog.org+82-2-512-5444

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Apr 17, 2026