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

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 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


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

Value
https://center6.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