UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008390 |
|---|---|
| Receipt number | R000009864 |
| Scientific Title | Paclitaxel plus carboplatin for advanced or recurrent carcinosarcoma of the uterus in Japan. |
| Date of disclosure of the study information | 2012/07/09 |
| Last modified on | 2012/07/09 17:46:56 |
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Basic information
Public title
Paclitaxel plus carboplatin for advanced or recurrent carcinosarcoma of the uterus in Japan.
Acronym
TC combination chemotherapy for advanced or recurrent carcinosarcoma.
Scientific Title
Paclitaxel plus carboplatin for advanced or recurrent carcinosarcoma of the uterus in Japan.
Scientific Title:Acronym
TC combination chemotherapy for advanced or recurrent carcinosarcoma.
Region
| Japan |
Condition
Condition
advanced or recurrent carcinosarcoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this prospective multi-institutional study was to determine the response rate (RR), progression-free survival (PFS) and overall survival (OS), and to assess the toxicity of paclitaxel and carboplatin in uterine carcinosarcoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression-free survival
Overall Survival
Adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Paclitaxel 175 mg/m2 was delivered over three hours followed by carboplatin dosed to an area under the serum concentration-time curve (AUC) = 6 intravenously over 30 minutes, on day 1, every 3 weeks (one treatment cycle), until disease progression or adverse effects prohibited further therapy. The dosing of carboplatin was calculated to reach a target AUC of concentration multiplied by time according to the Calvert formula using an estimated glomerular filtration rate from the Cockgroft-Gault equation, and a minimum creatinine value of 0.6 was stipulated. A maximum body surface area used for paclitaxel dose calculations was set at 2.0 m2. The number of cycles given beyond a clinical complete response (CR) was at the discretion of the principal physician. Patients with a partial response or stable disease were encouraged to continue unless adverse effects prohibited further therapy.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Eligible patients had histologically confirmed, advanced stage III, IV, or recurrent CS with a measureable target lesion of ≥ 20 mm when measured by computed tomography (CT) and magnetic resonance imaging, or ≥ 10mm when measured by spiral CT.
Patients had to have at least one target lesion to assess response on this protocol as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria .
Two gynecologic pathologists performed a pathological slide review of the primary malignancy for all patients.
Patients of childbearing potential had to have a negative serum pregnancy test before entry onto the study and had to be practicing an effective form of contraception.
A minimum ECOG performance status of 0 to 2, granulocytes ≥ 1500/microL, platelets ≥ 100,000/microL, serum creatinine ≤ 1.5 X institutional upper limit of normal (ULN), adequate liver function with bilirubin ≤ 1.5 X institutional ULN, and AST and alkaline phosphatase ≤ 2.5 X the institutional ULN were also required. Patients were to have recovered from previous treatments and have no evidence of infection. Patients with neuropathy (sensory or motor) grade ≥ 1, according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 were excluded. Patients provided written informed consent consistent with institutional review board regulations before study entry.
Key exclusion criteria
Patients with prior cytotoxic chemotherapy were ineligible. Patients with a history of another invasive malignancy within the previous five years other than a non-melanoma skin cancer were excluded.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuo Yaegashi |
Organization
Tohoku University Hospital
Division name
Gynecology
Zip code
Address
1-1 Seiryo-machi, Aoba ward, Sendai, Miyagi, 9808574, Japan
TEL
022-717-7254
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadao Takano |
Organization
Tohooku University Hospital
Division name
Gynecology
Zip code
Address
1-1 Seiryo-machi, Aoba ward, Sendai, Miyagi, 9808574, Japan
TEL
022-717-7254
Homepage URL
ttakano@med.tohoku.ac.jp
Sponsor or person
Institute
Gynecology, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology, and by a grant-in-aid from the Ministry of Health, Labor and Welfare, Japan.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Japanese Uterine Sarcoma Group and Tohoku Gynecologic Cancer Unit
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Department of Obstetrics and Gynecology, Tohoku University, Sendai
Department of Gynecology, Miyagi Cancer Center, Miyagi
Department of Obstetrics and Gynecology, Iwate Medical University, Morioka
Department of Obstetrics and Gynecology, Akita University, Akita
Department of Obstetrics and Gynecology, Yamagata University, Yamagata
Department of Obstetrics and Gynecology, Hirosaki University
Department of Obstetrics and Gynecology, Fukushima Medical University
Department of Gynecology, Shikoku Cancer Center, Matsuyama
Department of Obstetrics and Gynecology, Tottori University, Yonago, Japan
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2005 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 09 | Day |
Last modified on
| 2012 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009864
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