UMIN-CTR Clinical Trial

Public title

Randomized Phase III Trial of Paclitaxel plus Carboplatin (TC) Therapy versus Irinotecan plus Cisplatin (CPT-P) Therapy as a First Line Chemotherapy for Clear Cell Carcinoma of the Ovary

Acronym

Phase III Trial of (TC) Therapy versus (CPT-P) Therapy for Clear Cell Carcinoma of the Ovary

Scientific Title

Randomized Phase III Trial of Paclitaxel plus Carboplatin (TC) Therapy versus Irinotecan plus Cisplatin (CPT-P) Therapy as a First Line Chemotherapy for Clear Cell Carcinoma of the Ovary

Scientific Title:Acronym

Phase III Trial of (TC) Therapy versus (CPT-P) Therapy for Clear Cell Carcinoma of the Ovary

Region

Japan	Asia(except Japan)	Europe

Condition

clear cell carcinoma of the ovary

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To compare the efficacy and safety of standard arm of paclitaxel plus carboplatin and experimental arm of irinotecan plus cisplatin in clear cell carcinoma of the ovary.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

Progression - Free Survival

Key secondary outcomes

Overall Survival,Response Rate,Adverse Event

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

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

Paclitaxel 175 mg/m2 day 1+ Carboplatin AUC 6 day 1 q 3 weeks 6 cycles

Interventions/Control_2

Irinotecan 60 mg/m2 day 1,8,15+ Cisplatin 60 mg/m2 day 1 q 4 weeks 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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1) Patients with a histological diagnosis of clear cell carcinoma of the ovary, FIGO Stages I to IV. All patients must have had appropriate surgery for ovarian carcinoma with appropriate tissue available for histological evaluation. In the case with concurrent presence of other histological cell types, clear cell histology must be dominant ( > 50%). The histological
diagnosis will be confirmed by a central pathology review (CPR) (Three pathology slides required.)
2) Age: 18 or older
3) ECOG Performance Status: 0 - 1
4) Reasonable organ function: Must be assessed within 14 days prior to randomization.
Absolute Neutrophil Count: 1,500 / mm3 or more
Platelet: 100,000 / mm3 or more
Renal Function: Serum creatinine should be 1.5 x institutional ULN or less. If patient has serum creatinine of 1 x ULN to 1.5 x ULN, she must have creatinine clearance > 60 ml/min
* Creatinine clearance should be calculated using the Modified Jelliffe formula
Hepatic Function: Bilirubin less than or equal to 1.5 x institutional ULN ( < CTCAE grade 1). AST (SGOT) and alkaline phosphatase less than or equal to 2.5 x institutional ULN ( < CTCAE grade 1).
Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE grade 1.
5) Patient must have signed informed consent.
6) Patients must be enrolled within 6 weeks after comprehensive staging surgery.

Key exclusion criteria

1) Patients with a current diagnosis of epithelial ovarian tumor of low malignant potential
2) Patients with other malignancies including synchronous primary endometrial cancer or a past history of primary endometrial cancer
3) Patients who have received prior chemotherapy or radiation therapy to treat the current disease
4) Patients who received intraperitoneal chemotherapy at the time of operation
5) Patients with a prior diagnosis of malignancy are not eligible. Exceptions are:
- stage 0 endometrial cancer
- carcinoma in situ of the cervix
- non-melanoma skin cancer
- other malignancies curatively treated and > 5 years without evidence of recurrence
6) Patients who have received prior radiotherapy
Exceptions
Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than 5 years prior to registration, and the patient remains free of recurrent or metastatic disease.
7) Patients who have received prior chemotherapy.
Exceptions
Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 5 years prior to registration, and that the patient remains free of recurrent or metastatic disease.
8,9,10) Patients with diarrhea greater than CTCAE grade1, active infection that requires antibiotics, ongoing gastrointestinal bleeding requiring blood product support
11) Patients with unstable angina or those who have had a myocardial infarction within the past six months.
Patients with evidence of abnormal cardiac conduction are eligible if their disease has been stable for the past six months.
12,13,14,16) Patients with bowel obstruction, interstitial pneumonitis, massive pleural effusion and/or ascites, known hypersensitivity to polyoxyethylated castor oil or any of four chemotherapeutic agents
15,17,18) Patients who are under treatment with Atazanavir, pregnant or lactating, would not permit completion of study or required follow-up.

Target sample size

662

Name of lead principal investigator

1st name
Middle name
Last name	Toru Sugiyama ,M.D.,Ph.D.

Organization

Iwate Medical University, School of Medicine

Division name

Department of Obsterics and Gynecology

Zip code

Address

Uchimaru 19-1, Morioka, Iwate 020-8505 Japan

TEL

019-651-5111

Email

jgog3017@insti.kitasato-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Toru Sugiyama ,M.D.,Ph.D.

Organization

GCIG/JGOG3017 Office

Division name

Iwate Medical University, School of Medicine, Department of Obsterics and Gynecology

Zip code

Address

Uchimaru 19-1, Morioka, Iwate 020-8505 Japan

TEL

019-651-5111

Homepage URL

http://www.jgog.gr.jp/

Email

jgog3017@insti.kitasato-u.ac.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

Date of disclosure of the study information

2006

Year

10

Month

10

Day

URL releasing protocol

http://www.jgog.gr.jp/

Publication of results

Published

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/27400948

Number of participants that the trial has enrolled

Results

- The results from the final analysis did not show a marked difference in both
PFS and OS between the patients who received the [standard treatment] and those whoreceived the [experimental treatment].
- The characteristics of side effect of these two treatments differ significantly.

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

Completed

Date of protocol fixation

2006

Year

09

Month

18

Day

Date of IRB

Anticipated trial start date

2006

Year

10

Month

01

Day

Last follow-up date

2013

Year

03

Month

01

Day

Date of closure to data entry

2013

Year

06

Month

01

Day

Date trial data considered complete

2013

Year

06

Month

01

Day

Date analysis concluded

2013

Year

09

Month

01

Day

Other related information

Registered date

2006

Year

10

Month

04

Day

Last modified on

2018

Year

08

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000604