UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000499 |
|---|---|
| Receipt number | R000000604 |
| 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 |
| Date of disclosure of the study information | 2006/10/10 |
| Last modified on | 2018/08/13 12:23:07 |
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Basic information
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
Condition
clear cell carcinoma of the ovary
Classification by specialty
| Obstetrics 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
| 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
jgog3017@insti.kitasato-u.ac.jp
Public contact
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/
jgog3017@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
http://www.jgog.gr.jp/
Publication of results
Published
Result
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
Progress
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000604
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