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

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 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


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

Value
https://center6.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