UMIN-CTR Clinical Trial

Public title

Randomized phase II/III trial comparing dose-dense Paclitaxel and Carboplatin (TC) therapy and conventional triweekly TC therapy for newly diagnosed or recurrent uterine carcinosarcoma

Acronym

Uterine carcinosarcoma dose-dense TC

Scientific Title

Randomized phase II/III trial comparing dose-dense Paclitaxel and Carboplatin (TC) therapy and conventional triweekly TC therapy for newly diagnosed or recurrent uterine carcinosarcoma

Scientific Title:Acronym

Uterine carcinosarcoma dose-dense TC

Region

Japan

Asia(except Japan)

Condition

uterine carcinosarcoma

Classification by specialty

Hematology and clinical oncology

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To test the hypothesis that treatment with dose-dense TC chemotherapy is superior to treatment with conventional triweekly TC treatment in patients with stage I-IV and chemotherapy-naive recurrent uterine carcinosarcoma with respect to the progression-free survival.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II,III

Primary outcomes

progression-free survival

Key secondary outcomes

overall survival, response rate, adverse events

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

triweekly administration of paclitaxel 175mg/m2 and carboplatin AUC6 for 6 cycles

Interventions/Control_2

weekly administration of paclitaxel 80mg/m2 every week and triweekly administration of carboplatin AUC6 for 6 cycles

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1) Patients who have been diagnosed with FIGO Stage I-IV uterine carcinosarcoma by histopathology of isolated tissues, and patients with recurrent uterine carcinosarcoma who have been confirmed to have distant metastasis at the first onset. Patients who have not undergone hysterectomy are also included in this study if the patients have been diagnosed with uterine carcinosarcoma by biopsy or curettage specimens.
2) Patients who have not undergone chemotherapy before radiotherapy. The period from the completion of radiotherapy to the beginning of protocol treatment should be at least 4 weeks.
3) Patients with ECOG performance status of 0-2
4) Patients who have undergone surgery within 8 weeks before adjuvant treatment.
5) 20 years of age and older (at registration)
6) Patients must have normal hematologic, renal and hepatic function:
Granulocytes >=1500/mcl, platelets >=75000/mcl and hemoglobin >=10 g/dL
Creatinine <=1.5x institutional normal
Bilirubin <=1.5x institutional normal
AST and ALP <=3x institutional normal
Neuronal function: </=Grage 1 of neuropathy (motor, sense) (CTCAE ver. 4).
7) Patients who have provided written informed consent for the participation in this study.

Key exclusion criteria

1) Patients with infectious disease requiring antimicrobial agent.
2) Patients who have undergone chenotherapy for the primary disease.
3) Patients with a history of other invasive malignancies, with the exception of intraepithelial carcinoma of the uterine cervix, non-melanoma skin cancer, if there is any evidence of other malignancy being present within the last 5 years. Patients are also excluded if their previous cancer treatment contraindicates this protocoltherapy.
4) Patients with serious complication (e.g. heart disease, uncontrollable diabetes mellitus, malignant hypertension, bleeding tendency).
5) Patients with active multiple cancers.
6) Patients with pneumonitis or pulmonary fibrosis.
7) Patients with fluid retention requiring treatment.
8) Patients with repeated gastrointestinal bleeding requiring blood products.
9) Patients with a history of unstable angina or myocardial infarction within 6 months before registration, or with complicated severe arrhythmia requiring treatment. However, patients with abnormal cardiac conduction system (e.g. fascicular block, bundle branch block) who have been stable for 6 months before registration is not excluded.
10) Patients who have a contraindication to paclitaxel and carboplatin.
11) Patients with intestinal paralysis or ileus.
12) Patients with a history of severe drug hypersensitivity or allergy.
13) Patients who have been judged to be inappropriate for this study by the investigator

Target sample size

400

Name of lead principal investigator

1st name
Middle name
Last name	Toshiaki Saito

Organization

National Kyushu Cancer Center

Division name

Department of Gynecology,

Zip code

Address

3-1-1 Nodame, Minami-ku, Fukuoka city

TEL

092-541-3231

Email

tsaitou@nk-cc.go.jp

Name of contact person

1st name
Middle name
Last name	Kenichi Harano

Organization

National Cancer Center Hospital East

Division name

Department of Experimental Therapeutics

Zip code

Address

6-5-1 Kashiwanoha, Kashiwa city

TEL

04-7133-1111

Homepage URL

Email

kharano@east.ncc.go.jp

Institute

Japanese Gynecologic Oncology Group

Institute

Department

Personal name

Organization

Japanese Gynecologic Oncology Group

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

JGOG加盟施設

Date of disclosure of the study information

2017

Year

01

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2016

Year

12

Month

31

Day

Date of IRB

Anticipated trial start date

2017

Year

02

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

01

Month

27

Day

Last modified on

2017

Year

01

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029756