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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008023
Receipt No. R000009441
Scientific Title Phase II multicenter trial of neoadjuvant chemotherapy followed by radical hysterectomy and adjuvant chemotherapy by irrinotecan hydrochloride and nedaplatin for the patients with stage Ib2-IIb bulky cervical cancer (tumor diameter > 4 cm): OGSK_KCOG-G1201
Date of disclosure of the study information 2012/05/28
Last modified on 2017/05/29

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Basic information
Public title Phase II multicenter trial of neoadjuvant chemotherapy followed by radical hysterectomy and adjuvant chemotherapy by irrinotecan hydrochloride and nedaplatin for the patients with stage Ib2-IIb bulky cervical cancer (tumor diameter > 4 cm): OGSK_KCOG-G1201
Acronym NACRAC study
Scientific Title Phase II multicenter trial of neoadjuvant chemotherapy followed by radical hysterectomy and adjuvant chemotherapy by irrinotecan hydrochloride and nedaplatin for the patients with stage Ib2-IIb bulky cervical cancer (tumor diameter > 4 cm): OGSK_KCOG-G1201
Scientific Title:Acronym NACRAC study
Region
Japan

Condition
Condition Cervical cancer
Classification by specialty
Obsterics and gynecology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This phase II multicenter trial aims to evaluate the efficacy of neoadjuvant chemotherapy followed by radical hysterectomy and adjuvant chemotherapy by irrinotecan hydrochloride and nedaplatin for the patients with stage Ib2-IIb bulky cervical cancer (tumor diameter > 4 cm).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 2-year relapse-free survival
Key secondary outcomes 1. Tumor regression, 2. Adverse event, 3. Recurrence rate, 4. Chemotherapy completion rate, 5. Change of serum SCC level, 6. Surgery completion rate, 7. Surgical complication

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 Maneuver
Interventions/Control_1 The subjects undergo neoadjuvant chemotherapy followed by radical hysterectomy and adjuvant chemotherapy by irrinotecan hydrochloride and nedaplatin.
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. Histologically confirmed diagnosis of cervical squamous cell carcinoma, 2. Locally advanced stage Ib2-IIb disease, 3. Presense of a MRI measurable bulky mass in the uterince cervix, 4. No past medical history about cervical cancer, 5. Age: 20-75 years, 6. Acceptable major organ function, 7. ECOG Performance Status: 0-1, 8. Patients are scheduled for radical hysterectomy, 9. Patient must have signed informed consent
Key exclusion criteria 1. Patients with an active or uncontrolled infection, 2. Patients with a serious complications (cardiac disease, poorly controlled diabetes mellitus, malignant hypertension and bleeding tendency), 3. Patients with other malignancies, 4. Patients with interstitial pneumonitis, 5. Patients with massive pleural effusion and/or ascites, 6. Patients with unstable angina or those who have had a myocardial infarction within the past six months, 7. Patients with medical contraindications to irrinotecan hydrochloride and nedaplatin, 8. Patients with severe diarrhea, 9. Patients with bowel obstruction, 10. Patients who are pregnant or lactating, 11. Patients with severe drug allergy, 12. Patients whose circumstances at the time of entry onto the protocol would not permit completion of study required follow-up, 13. Patients with HBsAg positivity
Target sample size 68

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taisuke Mori
Organization Kyoto Prefectural University of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN
TEL 075-251-5560
Email moriman@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Morio Sawada
Organization Kyoto Prefectural University of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN
TEL 075-251-5560
Homepage URL
Email mosawada@koto.kpu-m.ac.jp

Sponsor
Institute The Obstetrical and Gynecological Society of Kinki District Japan and the Kansai Clinical Oncology Group
Institute
Department

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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 OGSK_KCOG-G1201
Org. issuing International ID_1 The Kansai Clinical Oncology Group
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 28 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 Enrolling by invitation
Date of protocol fixation
2012 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 05 Month 24 Day
Last modified on
2017 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009441

Research Plan
Registered date File name
2017/05/29 CxCa NAC_KCOG study_20120619.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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