A Trial of Tamoxifen and Letrozole in Recurrent and Persistent Squamous Cell Carcinoma of the Cervix
Status:
Unknown status
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
The investigators design a phase 2, open labeled, randomized trial of Tamoxifen (20 mg/day)
and Letrozole (2.5 mg) in treatment of squamous carcinoma of the cervix. Forty four patients
with recurrent or persistent disease will be recruited, randomized, treated and followed
three-monthly for 12 months. The primary end point is the treatment response rates. Secondary
end points include survivals, ECOG performance status, quality of life and efficacy of
biomarkers in predicting the responses. Candidate biomarkers including ER, PR, GPER and HPV
genotype in paraffin cancer tissues as well as methylated genes in the blood will be studied
in relation to the therapeutic outcomes.
Phase:
Phase 2
Details
Lead Sponsor:
Buddhist Tzu Chi General Hospital
Collaborators:
Chang Gung Memorial Hospital China Medical University Hospital Chung Shan Medical University Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Veterans General Hospital. National Cheng-Kung University Hospital Taiwan Ministry of Science and Technology