UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000552 |
|---|---|
| Receipt number | R000000672 |
| Scientific Title | A phase 2 neoadjuvant chemotherapy of Irinotecan (CPT-11) plus Nedaplatin (NDP) for stage 1b2 or 2 cervical cancer of the uterine cervix |
| Date of disclosure of the study information | 2006/12/21 |
| Last modified on | 2018/08/13 12:34:20 |
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Basic information
Public title
A phase 2 neoadjuvant chemotherapy of Irinotecan (CPT-11) plus Nedaplatin (NDP) for stage 1b2 or 2 cervical cancer of the uterine cervix
Acronym
A phase 2 neoadjuvant chemotherapy for early stage cervical cancer
Scientific Title
A phase 2 neoadjuvant chemotherapy of Irinotecan (CPT-11) plus Nedaplatin (NDP) for stage 1b2 or 2 cervical cancer of the uterine cervix
Scientific Title:Acronym
A phase 2 neoadjuvant chemotherapy for early stage cervical cancer
Region
| Japan |
Condition
Condition
stage 1b2/2 cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Both the beneficial effects and the adverse toxicities with neoadjuvant chemotherapy of Irinotecan (CPT-11) plus Nedaplatin (NDP) for early stage cervival cancer are studied in a phase 2 setting. The primary effect is estimated for the rate of decrease in a longtudinal diameter according yon the RECIST criteria.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tumor Response
Key secondary outcomes
1The number of courses whiche produced PR or CR
2Toxicity
3The chage of serum SCC level
4Completeness of surgery
5Pathological findings
6Difficaltiness of surgery:blood loss and operation time
7Complications of surgery
8Relapse-Free Survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The Radical hysterectomy surgery after Irinotecan 60mg/m2 day 1,8+Nedaplatin 80mg/m2 day1 q3weeks 1-3 courses
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Pathologicaly confirmed Cervi(Squamous cell carcinoma)
2)FIGO Stage1b2,2a(measurable lesion>=40mm by palpation or MRI)or 1b(measurable lesion>=20mm by palpation or MRI)
3)Measurable lesion by palpation or MRI
4)No prior chemotherapy
5)20 years-old<=age<=75 years-old
6)Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
7)Able to completely have radical hysterectomy
8)Adequate bone marrow,cardiac,pulmonry functions(Lab data must be within 14 days from the registration)
1 Absolute neutrophil count:>= 2,000/mm3
2 Platelet count:>= 100,000/mm3
3 Hemoglobin:>= 9.0g/dL
4 AST/ALT:<100IU/l
5 Bilirubin:<1.5mg/dL
6 Serum creatinine: <1.2mg/dL
7 creatinine clearance >60ml/min
8 ECG Normal
9)Written informed consent
Key exclusion criteria
1)Patients with active infections
2)Patients with serious complications(cardiac disease,uncontrolled diabetes mellitus,malignant hypertension,hemorrhagic tendancy)
3)Patients with active concomitant malignancy
4)Patients with interstitial pneumonia or pulmonary fibrosis
5)Patients with massive pleural, cardiac effusion, and/or ascites
6)Patients with unstable angina,history of cardiac infarction within 6 months,or arrhythmia that requires medical treatment
7)Patients with coneraindication to CPT-11or NDP
8)Patients with diarrhea (watery stool)
9)Patients with intestinal paralysis or illeus
10)Patients during pregnancy or breast-feeding,or unwilling to the use of contraception
11)Patients with any history of serious drug reactions or hypersensitivity
12)Patients who are inappropriate to enter this study with any safety reasons,judged by the treating physician
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Takizawa, M.D. |
Organization
JAPANESE FOUNDATION FOR CANCER RESEARCH CANCER INSTITUTE HOSPITAL
Division name
Department of Gynecology
Zip code
Address
3-10-6 Ariake, Koutou-ku, Tokyo, 135-8550 Japan
TEL
03-3520-0111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Takizawa, M.D. |
Organization
JGOG1065 Coordinating Office
Division name
JAPANESE FOUNDATION FOR CANCER RESEARCH
Zip code
Address
3-10-6 Ariake, Koutou-ku, Tokyo, 135-8550 Japan
TEL
03-3520-0111
Homepage URL
http://www.jgog.gr.jp/
ken.takizawa@ifcr.or.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 | 12 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/22614251
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
| 2006 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2009 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 12 | Month | 21 | 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=R000000672
