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A Trial of Tamoxifen and Letrozole in Recurrent and Persistent Squamous Cell Carcinoma of the Cervix

NCT02482740 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2015-06-26

No results posted yet for this study

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.

Conditions

  • Uterine Cervical Neoplasms

Interventions

DRUG

Letrozole

letrozole 2.5 mg qd was given for 12 months or till disease progress

DRUG

tamoxifen

tamoxifen was given 20 mg qd for 12 months or till disease progress

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • Chung Shan Medical University

    collaborator OTHER

  • China Medical University Hospital

    collaborator OTHER

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    collaborator OTHER

  • Kaohsiung Veterans General Hospital.

    collaborator OTHER

  • Ministry of Science and Technology, Taiwan

    collaborator OTHER_GOV

  • Buddhist Tzu Chi General Hospital

    lead OTHER

Principal Investigators

  • Tang Yuan Chu, PhD · Department of Obstetrics and Gynecology, Buddhist Tzu Chi General Hospital, 707, Section 3, Chung Yang Road, Hualien 970, Taiwan (R.O.C.)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-01-31
Completion
2017-06-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02482740 on ClinicalTrials.gov