UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005605 |
|---|---|
| Receipt number | R000006624 |
| Scientific Title | Phase II study of adjuvant chemotherapy with paclitaxel (PTX)plus nedaplatin (NDP)for stage Ib2 or IIa node-positive cervical cancer |
| Date of disclosure of the study information | 2011/05/17 |
| Last modified on | 2019/05/23 21:13:50 |
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Basic information
Public title
Phase II study of adjuvant chemotherapy with paclitaxel (PTX)plus nedaplatin (NDP)for stage Ib2 or IIa node-positive cervical cancer
Acronym
KCOG G1101
Scientific Title
Phase II study of adjuvant chemotherapy with paclitaxel (PTX)plus nedaplatin (NDP)for stage Ib2 or IIa node-positive cervical cancer
Scientific Title:Acronym
KCOG G1101
Region
| Japan |
Condition
Condition
Uterine cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate efficacy and safety of adjuvant chemotherapy with PTX plus nedaplatin NDP for stage Ib2 or IIa node-positive cervical cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
2 year progression free survival rate
Key secondary outcomes
Rate of adverse events,
Compliance of chemotherapy
5 year oveall survival rate
5 year progression free survival rate
Rate of the events of lymph-edema of legs
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
Administer PTX plus nedaplatin to the patients with stage Ib2 or IIa node-positive cervical cancer for adjuvant chemotherapy.
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) Patients with a histological diagnosis of squamous cell carcinoma of uterine cervix
2) FIGO stage IB2 or IIa patients with invasion to parametrium which was histologically diagnosed
3)Patients with lymph-node metastasis which was histologically diagnosed after radical hysterectomy
4)No residual tumor after hysterectomy
5)No previous treatment for cervical cancer
6)Patients who are 20 years old or older and younger than 75 years old at the enrollment
7)ECOG Performance Status: 0-1
8) Patients who satisfy following organ function
Test Reference range
Bone marrow function
WBC 3,000-12,000/mm3
ANC >=1,500/ mm3
Hb >=9.0g/dL
Platelet >=100,000/ mm3
Liver function
AST, ALT 2.5 times of institutional upper normal limit or less
ALP 2.5 times of institutional upper normal limit or less
Bilirubin <1.2mg/dL
Renal function
Serum creatinine 1.5 times of institutional upper normal limit or less
Cardiac function
LVEF >=50%
ECG within normal limits or no symptoms without the need of treatment
9) Patients who have signed informed consent
10) Patients who are expected to start protocol treatment within 6 weeks after surgery
Key exclusion criteria
1) Patients with para-aortic lymphnode metastasis which was histologically dianosed
2) Patients with surgical martin positive
3) Patients with ovarian or fallopian metastasis
4) Patients with peritoneal metasitasis
5) Patients with motor and/or sensory neurological disfunction
6) Patients with history of hypersensitive reaction to alcohol
7) Patients with active bacterial infection
8) Patients with serious complication
9) Patients with diagnosis of active multiple cancers: exceptions are carcinoma in situ that is curatively treated by local treatment, and intramucosal carcinoma like lesion
10) Patients with interstitial pneumonitis / pulmonary fibrosis
11) Patients with ascites and/or pleural effusion which needs treatment
12) Patients with contraindication of administration of PTX and/or NDP
13 Patients who are decided to be ineligible for this study by the principal investigator ( or subinvestigator )
Target sample size
63
Research contact person
Name of lead principal investigator
| 1st name | Munetaka |
| Middle name | |
| Last name | Takekuma |
Organization
Shizuoka Cancer Center
Division name
Division of Gynecology
Zip code
411-8777
Address
1007, Shimonagakubo, Nagaizumicho, Suntogun, Shizuoka
TEL
055-989-5222
m.takekuma@scchr.jp
Public contact
Name of contact person
| 1st name | Munetaka |
| Middle name | |
| Last name | Takekuma |
Organization
Shizuoka Cancer Center
Division name
Division of Gynecology
Zip code
411-8777
Address
1007, Shimonagakubo, Nagaizumicho, Suntogun, Shizuoka
TEL
055-989-5222
Homepage URL
m.takekuma@scchr.jp
Sponsor or person
Institute
Kansai Clinical oncology Group (KCOG)
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Cancer Center, IRB
Address
1007 Shimonagakubo, Nagaizumicho, Suntogun, Shizuoka
Tel
055-989-5222
h.kikuchi@scchr.jp
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
静岡がんセンター（静岡県）、関西労災病院（兵庫県）、兵庫医大付属病院（兵庫県）、三重大学付属病院（三重県）、奈良医大付属病院（奈良県）、県立奈良病院（奈良県）、名古屋市立大学付属病医（愛知県）、千船病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 17 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29575254
Number of participants that the trial has enrolled
63
Results
Their median age was 48.5 years (range 28-64). With a median follow-up of 45.7 months (range 23.4-69.5), the 2-year relapse-free survival and 2-year overall survival rates were 79.0% (90% CI, 69.0%-86.2%) and 93.5% (95% CI, 83.7%-97.5%), respectively. Almost all adverse events were relatively mild. Grade 3-4 adverse events (NCI-CTC ver. 4.0) that occurred in 5% or more of patients were neutropenia (60.7%) and infection (6.6%).
Results date posted
| 2019 | Year | 05 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
cervical squamous cell cancer, FIGO IB-IIA.
Patients with lymph node metastasis, pathologically confirmed after radical hysterectomy.
Age; 20-70 years.
PS: 0-1
Participant flow
administration of chemotherapy as an experimental treatment within 2 weeks after enrollment.
Adverse events
Almost all adverse events were relatively mild. Grade 3-4 adverse events (NCI-CTC ver. 4.0) that occurred in 5% or more of patients were neutropenia (60.7%) and infection (6.6%).
Outcome measures
the 2-year relapse-free survival and 2-year overall survival rates were 79.0% (90% CI, 69.0%-86.2%) and 93.5% (95% CI, 83.7%-97.5%), respectively
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2011 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 16 | Day |
Last modified on
| 2019 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006624
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