UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	Phase III Trial of (TC) Therapy versus (CPT-P) Therapy for Clear Cell Carcinoma of the Ovary
Region	Japan Asia(except Japan) Europe

Condition
Condition	clear cell carcinoma of the ovary
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	Progression - Free Survival
Key secondary outcomes	Overall Survival,Response Rate,Adverse Event

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Toru Sugiyama ,M.D.,Ph.D.
Organization	Iwate Medical University, School of Medicine
Division name	Department of Obsterics and Gynecology
Address	Uchimaru 19-1, Morioka, Iwate 020-8505 Japan
TEL	019-651-5111
Email	jgog3017@insti.kitasato-u.ac.jp

Public contact
Name of contact person	Toru Sugiyama ,M.D.,Ph.D.
Organization	GCIG/JGOG3017 Office
Division name	Iwate Medical University, School of Medicine, Department of Obsterics and Gynecology
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

Sponsor
Institute	Japanese Gynecologic Oncology Group
Institute
Department

Funding Source
Organization	Japanese Gynecologic Oncology Group
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2006 Year 10 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 09 Month 18 Day
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

Related information
URL releasing protocol	http://www.jgog.gr.jp/
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/27400948
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.
Other related information

Management information
Registered date	2006 Year 10 Month 04 Day
Last modified on	2018 Year 08 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000604