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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008390
Receipt No. 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

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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
Obsterics 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 &#8805; 20 mm when measured by computed tomography (CT) and magnetic resonance imaging, or &#8805; 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 &#8805; 1500/microL, platelets &#8805; 100,000/microL, serum creatinine &#8804; 1.5 X institutional upper limit of normal (ULN), adequate liver function with bilirubin &#8804; 1.5 X institutional ULN, and AST and alkaline phosphatase &#8804; 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 &#8805; 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
Email

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
Email ttakano@med.tohoku.ac.jp

Sponsor
Institute Gynecology, Tohoku University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009864

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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