UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008023 |
|---|---|
| Receipt number | 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 16:39:55 |
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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
| Obstetrics 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
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
mosawada@koto.kpu-m.ac.jp
Sponsor or person
Institute
The Obstetrical and Gynecological Society of Kinki District Japan and the Kansai Clinical Oncology Group
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009441
