Cervical CancerPhase 2NCT01487226
Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in Cervical Cancer
A Phase 2 study testing paclitaxel and Cisplatin 50mg/m2 in people with Cervical Cancer, run by Korean Gynecologic Oncology Group at 1 site in South Korea.
Trial summary
Purpose Primary endpoint To evaluate the 3-year disease free survival Second endpoints To evaluate the 3-year \& 5-year overall survival To analyze the toxicity and the quality of life Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- paclitaxel and Cisplatin 50mg/m2
- How many people
- 69 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2008to Jan 2015
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cervical cancer stage Ia2-IIa
- histology; squamous, adeno, adenosquamous subtype
- age; 20∼70 years
- performance status; GOG 0∼2
- no medical illness
- hematologic, renal, hepatic function; normal
Show all 10Show fewer
- grossly no residual disease
- histologically confirmed lymph nodes metastases
- no parametrial extension and negative resection margin
- number of retrieved lymph nodes; ≥ 20
Who cannot join
- patients with grade 2 peripheral neuropathy
- patients with uncontrolled infection
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
KGOG
Seoul
Eunkyung Park, 8225125420, koreagynonco@gmail.com
About this study
Official title: A Phase II Trial of Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in FIGO Stage IA2-IIA Cervical Cancer
Purpose Primary endpoint
- To evaluate the 3-year disease free survival Second endpoints
- To evaluate the 3-year \& 5-year overall survival To analyze the toxicity and the quality of life
- Conditions
- Cervical Cancer
- Being tested
- paclitaxel, Cisplatin 50mg/m2
- Keywords
- Cervical cancer
- 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.
paclitaxelDrug
Paclitaxel 175 mg/m2 over 3 hr Repeat every 3 weeks * 6 cycles
Cisplatin 50mg/m2Drug
Also called Cisplatin
Cisplatin 50mg/m2
Repeat every 3 weeks * 6 cycles
What is being measured
The primary outcome is the main question the study is designed to answer.
Kaplan-Meier
Secondary outcomes (1)
log-rank test Cox regression analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startJan 2008
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean Gynecologic Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taek Sang Lee, Korean Gynecologic Oncology Group
- Investigators
- Jong Min Lee, MD, Principal investigator, Kyung-Hee University East-West Med. Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487226
- Sponsor's protocol ID
- KGOG1012
- Status last verified
- Dec 2011
- First submitted
- 4 Dec 2011
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in FIGO Stage IA2-IIA Cervical Cancer
- ClinicalTrials.gov ID
- NCT01487226
- Acronym / sponsor ID
- KGOG1012
- Conditions
- Cervical Cancer
- Keywords
- Cervical cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Korean Gynecologic Oncology GroupUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 7 Dec 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.
Purpose Primary endpoint
- To evaluate the 3-year disease free survival Second endpoints
- To evaluate the 3-year \& 5-year overall survival To analyze the toxicity and the quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- cervical cancer stage Ia2-IIa
- histology; squamous, adeno, adenosquamous subtype
- age; 20∼70 years
- performance status; GOG 0∼2
- no medical illness
Key exclusion criteria (2 listed)
- patients with grade 2 peripheral neuropathy
- patients with uncontrolled infection
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 |
|---|---|---|
| paclitaxelPaclitaxel 175 mg/m2 over 3 hr Repeat every 3 weeks * 6 cycles | Drug | – |
| Cisplatin 50mg/m2Also: CisplatinCisplatin 50mg/m2 Repeat every 3 weeks * 6 cycles | Drug | – |
Primary outcome
Kaplan-Meier
1 secondary outcome
log-rank test Cox regression analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2011.
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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.
Jong Min Lee, MD principal investigator
Kyung-Hee University East-West Med. Center
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 paclitaxel and Cisplatin 50mg/m2 in people with Cervical Cancer, run by Korean Gynecologic Oncology Group 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 10 inclusion and 2 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 7 Dec 2011. 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 Eunkyung Park (8225125420, koreagynonco@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kaplan-Meier. 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 7 Dec 2011.