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Recruitment status Terminated
Unique ID issued by UMIN UMIN000007458
Receipt No. R000008534
Scientific Title Phase I study of combination chemotherapy with irinotecan hydrochroride(CPT-11) and nedaplatin(NDP) for locally advanced stage Ib2-IVa cervical cancer after Concurrent chemoradiotherapy (CCRT)
Date of disclosure of the study information 2012/03/06
Last modified on 2013/10/07

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Basic information
Public title Phase I study of combination chemotherapy with irinotecan hydrochroride(CPT-11) and nedaplatin(NDP) for locally advanced stage Ib2-IVa cervical cancer after Concurrent chemoradiotherapy (CCRT)
Acronym Phase I study of combination chemotherapy with CPT-11 and NDP for cervical cancer after CCRT
Scientific Title Phase I study of combination chemotherapy with irinotecan hydrochroride(CPT-11) and nedaplatin(NDP) for locally advanced stage Ib2-IVa cervical cancer after Concurrent chemoradiotherapy (CCRT)
Scientific Title:Acronym Phase I study of combination chemotherapy with CPT-11 and NDP for cervical cancer after CCRT
Region
Japan

Condition
Condition Stage Ib2-IVa cervical cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the maximum tolerated dose(MTD) and the recommended dose(RD)
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Recommended Dose(RD)
Key secondary outcomes 1)Incidence of morbidity
2)Completeness

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 Irinotecan dose escalation day 1,8+Nedaplatin dose escalation day 1,q 4 weeks 4 cycles. Treatment cycles are repeated every 28 days until disease progression, unless the dose level is considered as the DLT in the first cycle.
Level 1: Irinotecan 40 mg/m2 day 1,8+Nedaplatin 50mg/m2
Level 2: Irinotecan 40 mg/m2 day 1,8+Nedaplatin 60mg/m2
Level 3: Irinotecan 50 mg/m2 day 1,8+Nedaplatin 60mg/m2
Level 4: Irinotecan 60 mg/m2 day 1,8+Nedaplatin 60mg/m2
If none of the 3 patients who had been originally allocated to a dosage level experienced
DLT, the dose of pemetrexed was increased to the next level. If one of the 3 patients experienced DLT at that level, 3 additional patients were enrolled for the further evaluation of toxicity. If two of 3 patients experienced DLT at that level, that dose was defined as the MTD.
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
70 years-old >=
Gender Female
Key inclusion criteria 1) Pathologicaly confirmed cervical cancer (squamous cell carcinoma)
2) FIGO Stage lb2-lVa
3) Completely have Concurrent chemoradiotherapy(CCRT)
4) No prior therapy other than Concurrent chemoradiotherapy(CCRT)
5) 20 years-old<=age<=70 years-old
6) ECOG performance status of 0 to 1
7) Adequate bone marrow, cardiac, pulmonry functions.
8) Patients homozygous for UGT1A1*1, or heterozygous for UGT1A1*28 or UGT1A1*6
9) Written informed consent
10)Able to have a chemothrapy within 4-8 weeks after Concurrent chemoradiotherapy(CCRT)
Key exclusion criteria 1) Patients with serious complications
2) Patients with active infections
3) Patients with active concomitant malignancy
4) Patients underwent exploratory laparotomy
5) Patients with interstitial pneumonia or pulmonary fibrosis
6) Patients with massive pleural, cardiac effusion, and/or ascites
7) Patients with coneraindication to CPT-11or NDP
8) Patients with diarrhea (watery stool)
9) Patients with any history of serious drug reactions or hypersensitivity
10) Patients with HBs antigen
11) Patients treated with radiation therapy of the paraaortic lymph nodes in cervical carcinoma
12) Patients with progression of cervical carcinoma disease during concurrent chemoradiotherapy(CCRT)
13)Patients are inappropriate to enter this study with any safety reasons, judged by the treating physician
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisaya Fujiwara, M.D.,Ph.D.
Organization Chugoku Rousai Hospital
Division name Department of Obstetrics and Gynecology
Zip code
Address 1-5-5 Hirotagaya, Kure, Hiroshima 737-0193 Japan
TEL 0823-72-7171
Email hisafuji@chugokuh.rofuku.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisaya Fujiwara, M.D.,Ph.D.
Organization Chugoku Rousai Hospital
Division name Department of Obstetrics and Gynecology
Zip code
Address 1-5-5 Hirotagaya, Kure, Hiroshima 737-0193 Japan
TEL 0823-72-7171
Homepage URL http://www.jgog.gr.jp/
Email hisafuji@chugokuh.rofuku.go.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 広島大学病院(広島県)、琉球大学医学部附属病院(沖縄県)、東海大学医学部付属病院(神奈川県)、静岡県立がんセンター(静岡県)、がん研有明病院(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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 Terminated
Date of protocol fixation
2012 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2013 Year 10 Month 07 Day
Date of closure to data entry
2013 Year 10 Month 07 Day
Date trial data considered complete
2013 Year 12 Month 31 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 06 Day
Last modified on
2013 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008534

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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