UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase 2 neoadjuvant chemotherapy of Irinotecan (CPT-11) plus Nedaplatin (NDP) for stage 1b2 or 2 cervical cancer of the uterine cervix
Title of the study (Brief title)	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	Ken Takizawa, M.D.
Organization	JAPANESE FOUNDATION FOR CANCER RESEARCH CANCER INSTITUTE HOSPITAL
Division name	Department of Gynecology
Address	3-10-6 Ariake, Koutou-ku, Tokyo, 135-8550 Japan
TEL	03-3520-0111
Email

Public contact
Name of contact person	Ken Takizawa, M.D.
Organization	JGOG1065 Coordinating Office
Division name	JAPANESE FOUNDATION FOR CANCER RESEARCH
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 10 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/22614251
Results
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