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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000552
Receipt No. 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

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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
Obsterics 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
Email

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/
Email ken.takizawa@ifcr.or.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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000672

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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