Advanced or Recurrent Endometrial CancerPhase 2NCT01461759
Efficacy Study of Chemotherapy to Treat Advanced or Recurrent Endometrial Cancer
A Phase 2 study testing Doctaxel and Cisplatin in people with Advanced or Recurrent Endometrial Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to treat advanced or recurrent endometrial cancer, paclitaxel-containing regimen is the preferred chemotherapeutic regimen which is selected by most physicians. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Advanced or Recurrent Endometrial Cancer
- What is being tested?
- Doctaxel and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Dec 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 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed chemotherapy naïve endometrial cancer
- One of following histology Endometrioid, UPSC, CCCa, squamous, adenosquamous, mixed
- FIGO stage IVb or recurrent endometrial cancer (incurable by surgery and/or RT)
- At least one measurable lesion by RECIST on CT
- ECOG PS: 0-2
- Age: 20-75
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- Adequate organ function BM: ANC≥1,000/mm3, Plt≥100X103/mm3 Kidney: Creatinine<1.25 × UNL이고, GFR ≥ 60 Liver: AST, ALT< 3×UNL, T- bil<1.5 mg/ mm3
- Informed Consent
- Contraception during study period
Who cannot join
- Previous chemotherapy
- RT, hormone therapy, or immunotherapy within 1 month
- Other malignant disease
- Uncontrolled medical disease
- Infection requiring antibiotics
- Symptomatic CHF, RF, Angina, Arrhythmia, etc.
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- Neurosis or psychosis
- Pregnancy, breast-feeding
- Etc.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 138-736
Joo-Hyun Nam, M.D., Ph.D, +82-2-3010-3633, jhnam@amc.seoul.kr
About this study
Official title: A Phase II Trial of Docetaxel / Cisplatin in Patients With Recurrent or Stage IVb Endometrial Cancer
The purpose of this study is to treat advanced or recurrent endometrial cancer, paclitaxel-containing regimen is the preferred chemotherapeutic regimen which is selected by most physicians. Docetaxel may have similar efficacy and more favorable treatment related toxicity profile as tested in epithelial ovarian cancer trials. Therefore, the investigators aimed to evaluate the efficacy and safety of docetaxel plus cisplatin in patients with advanced or recurrent endometrial cancer.
- Conditions
- Advanced or Recurrent Endometrial Cancer
- Being tested
- Doctaxel, Cisplatin
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoctaxelDrug
Docetaxel 70mg/m2BSA, q 3 weeks, 8 cycles
CisplatinDrug
Cisplatin 60mg/m2BAS, q 3 weeks, 8 cycles
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Experimental | Docetaxel 70mg/m2BSA + Cisplatin 60mg/m2BSA, q 3 weeks, 8cycles Receives: Drug: Doctaxel; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: 3 months after completion of study treatment
Secondary outcomes (3)
Progression-free survival
Measured: 2 years after completion of study treatment
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Before each chemotherapy, an expected average of 3 weeks
Quality of life
Measured: 3 months after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Recurrent Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boryung Pharmaceutical Co., Ltd
- Responsible party
- Principal investigator, Joo-Hyun Nam, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461759
- Sponsor's protocol ID
- ANSGOG-002
- Status last verified
- May 2017
- First submitted
- 25 Oct 2011
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Docetaxel / Cisplatin in Patients With Recurrent or Stage IVb Endometrial Cancer
- ClinicalTrials.gov ID
- NCT01461759
- Acronym / sponsor ID
- ANSGOG-002
- Conditions
- Advanced or Recurrent Endometrial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Boryung Pharmaceutical Co., Ltd
- Study start
- Oct 2011
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Oct 2011 (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 purpose of this study is to treat advanced or recurrent endometrial cancer, paclitaxel-containing regimen is the preferred chemotherapeutic regimen which is selected by most physicians. Docetaxel may have similar efficacy and more favorable treatment related toxicity profile as tested in epithelial ovarian cancer trials. Therefore, the investigators aimed to evaluate the efficacy and safety of docetaxel plus cisplatin in patients with advanced or recurrent endometrial cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Experimental | Drug: Doctaxel, Drug: CisplatinDocetaxel 70mg/m2BSA + Cisplatin 60mg/m2BSA, q 3 weeks, 8cycles |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed chemotherapy naïve endometrial cancer
- One of following histology Endometrioid, UPSC, CCCa, squamous, adenosquamous, mixed
- FIGO stage IVb or recurrent endometrial cancer (incurable by surgery and/or RT)
- At least one measurable lesion by RECIST on CT
- ECOG PS: 0-2
Key exclusion criteria (9 listed)
- Previous chemotherapy
- RT, hormone therapy, or immunotherapy within 1 month
- Other malignant disease
- Uncontrolled medical disease
- Infection requiring antibiotics
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 |
|---|---|---|
| DoctaxelDocetaxel 70mg/m2BSA, q 3 weeks, 8 cycles | Drug | Chemotherapy |
| CisplatinCisplatin 60mg/m2BAS, q 3 weeks, 8 cycles | Drug | Chemotherapy |
Primary outcome
Response rate
Time frame: 3 months after completion of study treatment
3 secondary outcomes
Progression-free survival
Time frame: 2 years after completion of study treatment
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Before each chemotherapy, an expected average of 3 weeks
Quality of life
Time frame: 3 months after completion of study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doctaxel and Cisplatin in people with Advanced or Recurrent Endometrial Cancer, run by Asan Medical Center at 1 site in South Korea.
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 9 inclusion and 9 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 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 Joo-Hyun Nam, M.D., Ph.D. (+82-2-3010-3633, jhnam@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 3 months after completion of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2017.