UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007458 |
|---|---|
| Receipt number | 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 19:19:30 |
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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
| Obstetrics 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
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/
hisafuji@chugokuh.rofuku.go.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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008534
