Uterine Cervical NeoplasmsPhase 2TGOG1005NCT02482740
A Trial of Tamoxifen and Letrozole in Recurrent and Persistent Squamous Cell Carcinoma of the Cervix
A Phase 2 study testing Letrozole and tamoxifen in people with Uterine Cervical Neoplasms, run by Buddhist Tzu Chi General Hospital at 7 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 85 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- Letrozole and tamoxifen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 7 sitesTaiwan
- Study dates
- May 2015to Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With a histology proven primary squamous cell carcinoma of the cervix prior to the treatment failure
- Must sign and date informed consent.
- With age between 30 and 85
- With tissue blocks of the recurrent cancer lesion or primary cancer lesion available for the study.
- With a treatment-free interval of at least 4 weeks.
- With currently (within 1 month) measurable (by CT) tumor of at least 2 cm in one diameter (at least twice the scan slice thickness), AND elevated SCC level over 2 folds of the institutional upper limit of normal (ULN),
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- With a ECOG performance status score of 0 to 2,
- With adequate hematologic function (ANC≧500/uL and platelets≧50,000/uL),
- With adequate renal function (serum creatinine≦2.0 mg/dL; if higher, then creatinine clearance≧40 mL/min was required),
- With adequate hepatic function (ALT/AST ≦3.0 folds of ULN
Who cannot join
- With histology type other than SCC
- Had liver, brain metastasis or malignant ascites
- Those having multiple metastasis (more than one metastasis lesion)
- Whose cancer had been treated for more than three therapeutic courses [including 1 primary therapy (Operation+ CCRT is considered 1 primary therapy) and 2 secondary therapies] courses.
- Who have received any investigational drugs within 30 days prior to enrollment
- Who were pregnant or lactating
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- Who are taking selective serotonin receptor inhibitors (SSRI) (eg. Prozac, Celexa, Lexapro, Lubox, Paxi, Zoloft, etc.)
- With pulmonary embolism or other veneous embolism
- With uncontrolled medical conditions such as cardiac disease, cirrhosis of liver, active on chronic hepatitis, diabetes mellitus, autoimmune disease.
- With current or prior therapy (less than 3 months ) of selective estrogen receptor modulators (SERMs) (tamoxifen, raloxifen, fulvestrant, etc.), or aromatase inhibitors (eg. Letrozole, Anastrozole, Exemestane, Vorozole, Formestane, Fadrozole, etc.)
- Currently taking Warfarin or Rivaroxaben .
- With history of malignant disease, except those had been disease-free for at least 5 years.
- Patient who had allergy history to Tamoxifen or Letrozole
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Taiwan7 sites, 7 recruiting
- Not yet recruiting
Dept. of Obstetrics and Gynecology, Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, No 123, Dapi Rd, Niaosong Dist, 83301
Chan-Chao Chang, Bachelor, +886975056401, chanchao@adm.cgmh.org.tw
Hung-Chung Fu, +886975056423, allen133@adm.cgmh.org.tw
- Not yet recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, No.100, Ziyou 1st Rd., Sanmin Dist., 807-56
Yu-Chieh Chen, Master, +886975356642, benjamin2727@yahoo.com.tw
Yu-Chieh Chen, Master, +886975-356-642, benjamin2727@yahoo.com.tw
- Not yet recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City, No.386, Dazhong 1st Rd., Zuoying Dist., 81362
Wen-Shiung Liou, MD, +88673422121 ext. 8191, wsliou@vghks.gov.tw
Wen-Shiung Liou, MD, +886975581667, wsliou@vghks.gov.tw
- Not yet recruiting
Chung Shan Medical University Hospital
Taichung, No.110,sec. 1,Jianguo NRd.,South Dist., 40201
Chih-Jen Tseng, Master, +8864-24739595 ext. 34501, tsengcj@gmail.com
- Not yet recruiting
China Medical University Hospital
Taichung, No.2, Yude Rd., North Dist.,, 40447
Wu-Chou Lin, PhD, +886-4-22052121 ext. 2063, sun.bau@msa.hinet.net
Lian-Shung Yeh, Master, +886-4-22052121 ext. 2063, lsyeh@mail.cmuh.org.tw
- Not yet recruiting
National Cheng Kung University Hospital
Tainan, No.138, Shengli Rd., North Dist., 70403
Ching-I Wu, Bachelor
Ya-Min Cheng, +886921566219, chengym@mail.ncku.edu.tw
- Recruiting
Department of OB/GYN, Linkou Chang Geng Memorial Hospital
Taoyuan, Taoyuan, 333
Chyong-Huey Lai, .MD, +886975365883, jean0311@hotmail.com
Huei-Jean Huang, MD, +886975366298, hjhuang@cgmh.org.tw
About this study
Official title: An Open, Randomized, Multi-center, Phase 2 Trial of Tamoxifen and Letrozole in Recurrent and Persistent Squamous Cell Carcinoma of the Cervix: the Efficacy and New Biomarkers
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.
Read the detailed description
Although human papillomavirus (HPV) is a necessary cause of cervical cancer, HPV infection itself is inefficient and insufficient to cause cancer. New evidences have suggested endogenous and exogenous sex hormones confer risk of developing cervical cancer. In unscreened populations, incidence of cervical cancer starts after menarche and constantly increases before menopause, after then the incidence is flattening and declines [21]. Indeed, after menopause, newly incident CIN3 is seldom detected[22]. Large-scale epidemiological studies also showed high number of full-term pregnancy[23] (rather than abortion) and long-term use of hormonal contraceptives[24] to be independent risk factors of cervical cancer. These evidences pointed to female sex hormones to be another culprit of cervical cancer.
The role of estrogen and ERα on HPV-induced cervical carcinogenesis is best demonstrated by the pK14-HPV E6/E7transgenic mice which, without estrogen exposure, develop benign skin tumors only. However, when these mice are treated with exogenous estradiol at physiological level, they develop cervical cancers in nearly 100% efficiency[25-28]. These cervical neoplasia recapitulate characteristics of human cervical cancer in all aspects: originated from the squamous-columnar junction, with early lesions of atypical squamous metaplasia, CIN and to invasive squamous cell carcinoma [29]. Most importantly, removal of exogenous estrogen or castration of these mice led to diminish of progression and partial regression of pre-existing neoplasia[30].
The investigators design an open, randomized, multi-center trial of tamoxifen and letrozole in treatment of recurrent or persistent squamous cell carcinoma of the cervix. Patients with recurrent or persistent SCC of cervix who are not amenable for further cytotoxic treatment will be randomized by block and by participating center to one of the two arms. The block size will be two . Medication will be given orally in daily dose of tamoxifen (Nolvadex) 20 mg, letrozole (Femara) 2.5 mg until disease progression or until the end of the study.
Primary end point of the study is the response rate (complete response and partial response rates) for tamoxifen and letrozole arms. Secondary end points include progression-free survival (PFS) and overall survival (OS) compared to the historical results, ECOG Performance Status, quality of life and outcome predictors (biomarkers and clinical characteristics) of responsiveness and survival. The experienced survival data of the participating center will be compared.
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Uterine Cervical Neoplasms, antiestrogens
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called Femara
letrozole 2.5 mg qd was given for 12 months or till disease progress
tamoxifenDrug
Also called Nolvadex
tamoxifen was given 20 mg qd for 12 months or till disease progress
| Study group | Role | What they receive |
|---|---|---|
| tamoxifen | Experimental | tamoxifen 20 mg given everyday for 12 months Receives: Drug: tamoxifen |
| letrozole | Active comparator | letrozole 2.5 mg given everyday for 12 months Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The response rate
The guideline for the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) will be followed. Target tumor will be identified and followed by CT scan. Other efficacy parameters are tumor markers (SCC), and pelvic examination and physical examination findings.
Measured: one year
Secondary outcomes (4)
Progression-free survival
Progression-free survival (PFS) comparing to the historical results
Measured: one year
Quality of life
The European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life questionnaire cervical cancer module: EORTC QLQ-CX24 and C30 will be evaluated for every patient at every visit during study period.
Measured: one year
ECOG Performance Status
ECOG Performance status will be evaluated every visit during study period
Measured: one year
Overall survival
overall survival (OS) comparing to the historical results
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, Chung Shan Medical University, China Medical University Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Veterans General Hospital., Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Tang Yuan Chu, Buddhist Tzu Chi General Hospital
- Investigators
- Tang Yuan Chu, PhD, Principal investigator, Department of Obstetrics and Gynecology, Buddhist Tzu Chi General Hospital, 707, Section 3, Chung Yang Road, Hualien 970, Taiwan (R.O.C.)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482740
- Sponsor's protocol ID
- TGOG1005
- Acronym
- TGOG1005
- Status last verified
- Jun 2015
- First submitted
- 12 May 2015
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Plummer M, Peto J, Franceschi S; International Collaboration of Epidemiological Studies of Cervical Cancer. Time since first sexual intercourse and the risk of cervical cancer. Int J Cancer. 2012 Jun 1;130(11):2638-44. doi: 10.1002/ijc.26250. Epub 2011 Aug 12.
PubMed 21702036Rodriguez AC, Schiffman M, Herrero R, Hildesheim A, Bratti C, Sherman ME, Solomon D, Guillen D, Alfaro M, Morales J, Hutchinson M, Katki H, Cheung L, Wacholder S, Burk RD. Longitudinal study of human papillomavirus persistence and cervical intraepithelial neoplasia grade 2/3: critical role of duration of infection. J Natl Cancer Inst. 2010 Mar 3;102(5):315-24. doi: 10.1093/jnci/djq001. Epub 2010 Feb 15.
PubMed 20157096International Collaboration of Epidemiological Studies of Cervical Cancer. Cervical carcinoma and reproductive factors: collaborative reanalysis of individual data on 16,563 women with cervical carcinoma and 33,542 women without cervical carcinoma from 25 epidemiological studies. Int J Cancer. 2006 Sep 1;119(5):1108-24. doi: 10.1002/ijc.21953.
PubMed 16570271International Collaboration of Epidemiological Studies of Cervical Cancer; Appleby P, Beral V, Berrington de Gonzalez A, Colin D, Franceschi S, Goodhill A, Green J, Peto J, Plummer M, Sweetland S. Cervical cancer and hormonal contraceptives: collaborative reanalysis of individual data for 16,573 women with cervical cancer and 35,509 women without cervical cancer from 24 epidemiological studies. Lancet. 2007 Nov 10;370(9599):1609-21. doi: 10.1016/S0140-6736(07)61684-5.
PubMed 17993361Riley RR, Duensing S, Brake T, Munger K, Lambert PF, Arbeit JM. Dissection of human papillomavirus E6 and E7 function in transgenic mouse models of cervical carcinogenesis. Cancer Res. 2003 Aug 15;63(16):4862-71.
PubMed 12941807Shai A, Brake T, Somoza C, Lambert PF. The human papillomavirus E6 oncogene dysregulates the cell cycle and contributes to cervical carcinogenesis through two independent activities. Cancer Res. 2007 Feb 15;67(4):1626-35. doi: 10.1158/0008-5472.CAN-06-3344.
PubMed 17308103Arbeit JM, Howley PM, Hanahan D. Chronic estrogen-induced cervical and vaginal squamous carcinogenesis in human papillomavirus type 16 transgenic mice. Proc Natl Acad Sci U S A. 1996 Apr 2;93(7):2930-5. doi: 10.1073/pnas.93.7.2930.
PubMed 8610145Elson DA, Riley RR, Lacey A, Thordarson G, Talamantes FJ, Arbeit JM. Sensitivity of the cervical transformation zone to estrogen-induced squamous carcinogenesis. Cancer Res. 2000 Mar 1;60(5):1267-75.
PubMed 10728686Brake T, Connor JP, Petereit DG, Lambert PF. Comparative analysis of cervical cancer in women and in a human papillomavirus-transgenic mouse model: identification of minichromosome maintenance protein 7 as an informative biomarker for human cervical cancer. Cancer Res. 2003 Dec 1;63(23):8173-80.
PubMed 14678972Brake T, Lambert PF. Estrogen contributes to the onset, persistence, and malignant progression of cervical cancer in a human papillomavirus-transgenic mouse model. Proc Natl Acad Sci U S A. 2005 Feb 15;102(7):2490-5. doi: 10.1073/pnas.0409883102. Epub 2005 Feb 7.
PubMed 15699322
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomized, Multi-center, Phase 2 Trial of Tamoxifen and Letrozole in Recurrent and Persistent Squamous Cell Carcinoma of the Cervix: the Efficacy and New Biomarkers
- ClinicalTrials.gov ID
- NCT02482740
- Acronym / sponsor ID
- TGOG1005 / TGOG1005
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Uterine Cervical Neoplasms, antiestrogens
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, Chung Shan Medical University, China Medical University Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Veterans General Hospital., Ministry of Science and Technology, Taiwan
- Study start
- May 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Although human papillomavirus (HPV) is a necessary cause of cervical cancer, HPV infection itself is inefficient and insufficient to cause cancer. New evidences have suggested endogenous and exogenous sex hormones confer risk of developing cervical cancer. In unscreened populations, incidence of cervical cancer starts after menarche and constantly increases before menopause, after then the incidence is flattening and declines [21]. Indeed, after menopause, newly incident CIN3 is seldom detected[22]. Large-scale epidemiological studies also showed high number of full-term pregnancy[23] (rather than abortion) and long-term use of hormonal contraceptives[24] to be independent risk factors of cervical cancer. These evidences pointed to female sex hormones to be another culprit of cervical cancer.
The role of estrogen and ERα on HPV-induced cervical carcinogenesis is best demonstrated by the pK14-HPV E6/E7transgenic mice which, without estrogen exposure, develop benign skin tumors only. However, when these mice are treated with exogenous estradiol at physiological level, they develop cervical cancers in nearly 100% efficiency[25-28]. These cervical neoplasia recapitulate characteristics of human cervical cancer in all aspects: originated from the squamous-columnar junction, with early lesions of atypical squamous metaplasia, CIN and to invasive squamous cell carcinoma [29]. Most importantly, removal of exogenous estrogen or castration of these mice led to diminish of progression and partial regression of pre-existing neoplasia[30].
The investigators design an open, randomized, multi-center trial of tamoxifen and letrozole in treatment of recurrent or persistent squamous cell carcinoma of the cervix. Patients with recurrent or persistent SCC of cervix who are not amenable for further cytotoxic treatment will be randomized by block and by participating center to one of the two arms. The block size will be two . Medication will be given orally in daily dose of tamoxifen (Nolvadex) 20 mg, letrozole (Femara) 2.5 mg until disease progression or until the end of the study.
Primary end point of the study is the response rate (complete response and partial response rates) for tamoxifen and letrozole arms. Secondary end points include progression-free survival (PFS) and overall survival (OS) compared to the historical results, ECOG Performance Status, quality of life and outcome predictors (biomarkers and clinical characteristics) of responsiveness and survival. The experienced survival data of the participating center will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tamoxifen | Experimental | Drug: tamoxifentamoxifen 20 mg given everyday for 12 months |
| letrozole | Active comparator | Drug: Letrozoleletrozole 2.5 mg given everyday for 12 months |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- With a histology proven primary squamous cell carcinoma of the cervix prior to the treatment failure
- Must sign and date informed consent.
- With age between 30 and 85
- With tissue blocks of the recurrent cancer lesion or primary cancer lesion available for the study.
- With a treatment-free interval of at least 4 weeks.
Key exclusion criteria (13 listed)
- With histology type other than SCC
- Had liver, brain metastasis or malignant ascites
- Those having multiple metastasis (more than one metastasis lesion)
- Whose cancer had been treated for more than three therapeutic courses [including 1 primary therapy (Operation+ CCRT is considered 1 primary therapy) and 2 secondary therapies] courses.
- Who have received any investigational drugs within 30 days prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetrozoleAlso: Femaraletrozole 2.5 mg qd was given for 12 months or till disease progress | Drug | letrozole |
| tamoxifenAlso: Nolvadextamoxifen was given 20 mg qd for 12 months or till disease progress | Drug | tamoxifen |
Primary outcome
The response rate
Time frame: one year
The guideline for the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) will be followed. Target tumor will be identified and followed by CT scan. Other efficacy parameters are tumor markers (SCC), and pelvic examination and physical examination findings.
4 secondary outcomes
Progression-free survival
Time frame: one year
Quality of life
Time frame: one year
ECOG Performance Status
Time frame: one year
Overall survival
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
- Background: PubMed 21702036Plummer M, Peto J, Franceschi S; International Collaboration of Epidemiological Studies of Cervical Cancer. Time since first sexual intercourse and the risk of cervical cancer. Int J Cancer. 2012 Jun 1;130(11):2638-44. doi: 10.1002/ijc.26250. Epub 2011 Aug 12.
- Background: PubMed 20157096Rodriguez AC, Schiffman M, Herrero R, Hildesheim A, Bratti C, Sherman ME, Solomon D, Guillen D, Alfaro M, Morales J, Hutchinson M, Katki H, Cheung L, Wacholder S, Burk RD. Longitudinal study of human papillomavirus persistence and cervical intraepithelial neoplasia grade 2/3: critical role of duration of infection. J Natl Cancer Inst. 2010 Mar 3;102(5):315-24. doi: 10.1093/jnci/djq001. Epub 2010 Feb 15.
- Background: PubMed 16570271International Collaboration of Epidemiological Studies of Cervical Cancer. Cervical carcinoma and reproductive factors: collaborative reanalysis of individual data on 16,563 women with cervical carcinoma and 33,542 women without cervical carcinoma from 25 epidemiological studies. Int J Cancer. 2006 Sep 1;119(5):1108-24. doi: 10.1002/ijc.21953.
- Background: PubMed 17993361International Collaboration of Epidemiological Studies of Cervical Cancer; Appleby P, Beral V, Berrington de Gonzalez A, Colin D, Franceschi S, Goodhill A, Green J, Peto J, Plummer M, Sweetland S. Cervical cancer and hormonal contraceptives: collaborative reanalysis of individual data for 16,573 women with cervical cancer and 35,509 women without cervical cancer from 24 epidemiological studies. Lancet. 2007 Nov 10;370(9599):1609-21. doi: 10.1016/S0140-6736(07)61684-5.
- Background: PubMed 12941807Riley RR, Duensing S, Brake T, Munger K, Lambert PF, Arbeit JM. Dissection of human papillomavirus E6 and E7 function in transgenic mouse models of cervical carcinogenesis. Cancer Res. 2003 Aug 15;63(16):4862-71.
- Background: PubMed 17308103Shai A, Brake T, Somoza C, Lambert PF. The human papillomavirus E6 oncogene dysregulates the cell cycle and contributes to cervical carcinogenesis through two independent activities. Cancer Res. 2007 Feb 15;67(4):1626-35. doi: 10.1158/0008-5472.CAN-06-3344.
- Background: PubMed 8610145Arbeit JM, Howley PM, Hanahan D. Chronic estrogen-induced cervical and vaginal squamous carcinogenesis in human papillomavirus type 16 transgenic mice. Proc Natl Acad Sci U S A. 1996 Apr 2;93(7):2930-5. doi: 10.1073/pnas.93.7.2930.
- Background: PubMed 10728686Elson DA, Riley RR, Lacey A, Thordarson G, Talamantes FJ, Arbeit JM. Sensitivity of the cervical transformation zone to estrogen-induced squamous carcinogenesis. Cancer Res. 2000 Mar 1;60(5):1267-75.
- Background: PubMed 14678972Brake T, Connor JP, Petereit DG, Lambert PF. Comparative analysis of cervical cancer in women and in a human papillomavirus-transgenic mouse model: identification of minichromosome maintenance protein 7 as an informative biomarker for human cervical cancer. Cancer Res. 2003 Dec 1;63(23):8173-80.
- Background: PubMed 15699322Brake T, Lambert PF. Estrogen contributes to the onset, persistence, and malignant progression of cervical cancer in a human papillomavirus-transgenic mouse model. Proc Natl Acad Sci U S A. 2005 Feb 15;102(7):2490-5. doi: 10.1073/pnas.0409883102. Epub 2005 Feb 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tang Yuan Chu, PhD principal investigator
Department of Obstetrics and Gynecology, Buddhist Tzu Chi General Hospital, 707, Section 3, Chung Yang Road, Hualien 970, Taiwan (R.O.C.)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letrozole and tamoxifen in people with Uterine Cervical Neoplasms, run by Buddhist Tzu Chi General Hospital at 7 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mun Kun Hong, MD (+886-3-8561825 ext. 2224, jeff06038@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The response rate (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02482740, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2015.