Fallopian Tube CancerPhase 2NCT01570582
A Phase IIclinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
A Phase 2 study testing carboplatin and paclitaxel in people with Fallopian Tube Cancer and Ovarian Cancer, run by Korean Gynecologic Oncology Group at 1 site in South Korea.
Trial summary
purpose Primary endpoint To evaluate the 24 month disease free survival Second endpoints To evaluate the 24 month overall survival To analyze the toxicity and the quality of life Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cancer
- What is being tested?
- carboplatin and paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to Mar 2014
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with epithelial ovarian, fallopian tube cancer bokmakam or pathological diagnosis of recurrent states there must be must be present.
- Pathologically Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (NOS) have been diagnosed with possible participation.
- Patients with CA-125 (biochemical recurrence), as described below elevation or clinically measurable lesions or the measurement is not possible, as there should be evidence of recurrence.
- If at least one (record as the longest diameter) can be accurately measured in at least one lesion that is defined. For each lesion, such as MRI or CT, when measured by traditional methods should be at least 20mm spiral CT (spiral CT) have been measured to be less than 10mm when.
- Neutrophil (ANC) by 1500 / ㎣ more Platelet count 100,000 / ㎣ more Serum creatinine concentration 1.5mg/dL (133mol / l) or creatinine clearance less than 60ml/min should be at least two.
Who cannot join
- Patients must be at least 18 years of age.
- Patients with epithelial ovarian, fallopian tube cancer bokmakam or pathological diagnosis of recurrent states there must be must be present.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea Institute of Radiological and Medical Sciences
Seoul
About this study
Official title: A Phase II Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
purpose Primary endpoint
- To evaluate the 24 month disease free survival Second endpoints
- To evaluate the 24 month overall survival To analyze the toxicity and the quality of life
Read the detailed description
Approximately 48 month from the date of IRB approval
Patients enrolled in this study targets approximately 314 people. Completion of patient enrollment is expected to take approximately 24 month, approximately 24 month follow-up period is expected to be needed
- Being tested
- carboplatin and paclitaxel
- Keywords
- recurrent ovarian, ECG, GOG performance, Hematologic g, Blood chemistry and urinalysis h
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatin and paclitaxelDrug
Also called carboplatin , paclitaxel and Gemcitabine
Subjects assigned to Arm I Neople taksoljuwa Latin week the first day of the week based outpatient / inpatient treatment receive it. The subjects first received taksoljureul given over 3 hours followed by 30 minutes will be administered Neople Latin week.
| Study group | Role | What they receive |
|---|---|---|
| drug effect | Experimental | Subjects assigned to Arm I Neople taksoljuwa Latin week the first day of the week based outpatient / inpatient treatment receive it. The subjects first received taksoljureul given over 3 hours followed by 30 minutes will be administered Neople Latin week.
Subjects assigned to Arm II Gemcitabine and Latin Neople every week based on the first day of the outpatient / inpatient treatment receive it. The subjects first received Gemcitabine given over 30 minutes followed by 30 minutes will be administered Neople Latin week.
Gemcitabine and eighth day of the foreign / hospitalization are given over 30 minutes.
Regimen of the progression of the disease, the subject can not continue to deny or toxic dose every 3 weeks until at least 6 cycles should be administered to. Subjects completed six cycles of medication which responds subjects, the researchers believe it is necessary to sustain if the regimen is Receives: Drug: carboplatin and paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
24month progression free survival
Measured: 24 months
Secondary outcomes (1)
Toxicity Profile
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startMar 2010
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube 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
- 314 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570582
- Sponsor's protocol ID
- KGOG3017
- Status last verified
- Apr 2012
- First submitted
- 14 Mar 2012
- Last updated
- 4 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT01570582
- Acronym / sponsor ID
- KGOG3017
- Keywords
- recurrent ovarian, ECG, GOG performance, Hematologic g, Blood chemistry and urinalysis h
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Korean Gynecologic Oncology GroupUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 4 Apr 2012 (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 24 month disease free survival Second endpoints
- To evaluate the 24 month overall survival To analyze the toxicity and the quality of life
Detailed description
Approximately 48 month from the date of IRB approval
Patients enrolled in this study targets approximately 314 people. Completion of patient enrollment is expected to take approximately 24 month, approximately 24 month follow-up period is expected to be needed
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| drug effect | Experimental | Drug: carboplatin and paclitaxelSubjects assigned to Arm I Neople taksoljuwa Latin week the first day of the week based outpatient / inpatient treatment receive it. The subjects first received taksoljureul given over 3 hours followed by 30 minutes will be administered Neople Latin week. Subjects assigned to Arm II Gemcitabine and Latin Neople every week based on the first day of the outpatient / inpatient treatment receive it. The subjects first received Gemcitabine given over 30 minutes followed by 30 minutes will be administered Neople Latin week. Gemcitabine and eighth day of the foreign / hospitalization are given over 30 minutes. Regimen of the progression of the disease, the subject can not continue to deny or toxic dose every 3 weeks until at least 6 cycles should be administered to. Subjects completed six cycles of medication which responds subjects, the researchers believe it is necessary to sustain if the regimen is |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with epithelial ovarian, fallopian tube cancer bokmakam or pathological diagnosis of recurrent states there must be must be present.
- Pathologically Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (NOS) have been diagnosed with possible participation.
- Patients with CA-125 (biochemical recurrence), as described below elevation or clinically measurable lesions or the measurement is not possible, as there should be evidence of recurrence.
- If at least one (record as the longest diameter) can be accurately measured in at least one lesion that is defined. For each lesion, such as MRI or CT, when measured by traditional methods should be at least 20mm spiral CT (spiral CT) have been measured to be less than 10mm when.
- Neutrophil (ANC) by 1500 / ㎣ more Platelet count 100,000 / ㎣ more Serum creatinine concentration 1.5mg/dL (133mol / l) or creatinine clearance less than 60ml/min should be at least two.
Key exclusion criteria (2 listed)
- Patients must be at least 18 years of age.
- Patients with epithelial ovarian, fallopian tube cancer bokmakam or pathological diagnosis of recurrent states there must be must be present.
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 |
|---|---|---|
| carboplatin and paclitaxelAlso: carboplatin , paclitaxel and GemcitabineSubjects assigned to Arm I Neople taksoljuwa Latin week the first day of the week based outpatient / inpatient treatment receive it. The subjects first received taksoljureul given over 3 hours followed by 30 minutes will be administered Neople Latin week. | Drug | drug effect |
Primary outcome
24month progression free survival
Time frame: 24 months
1 secondary outcome
Toxicity Profile
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 carboplatin and paclitaxel in people with Fallopian Tube Cancer and Ovarian 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 5 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 4 Apr 2012. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24month progression free survival (time frame: 24 months). 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 4 Apr 2012.