A Trial of Neoadjuvant Chemotherapy + Surgery vs. Surgery... | NCT00190528

Studies
A Trial of Neoadjuvant Chemotherapy + Surgery vs. Surgery for Bulky Stage I/II Cervical Cancer

NCT00190528

Sponsor

Haruhiko Fukuda

Status

Terminated

Last Update Posted

Sep 22, 2016Estimated

Enrollment

200Actual

Phase

Phase 3

Conditions

Cervical Neoplasms

Interventions

neoadjuvant chemotherapy + radical hysterectomy
radical hysterectomy

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
C000000194

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2002

Primary Completion Date

Dec 2004Actual

Completion Date

Feb 2009Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2016

Last Update Posted Date

Sep 22, 2016Estimated

Name	Class
Ministry of Health, Labour and Welfare, Japan	OTHER_GOV

Description Module

Brief Summary

To investigate the clinical benefits of neoadjuvant chemotherapy for bulky stage I/II cervical cancer

Detailed Description

We designed this randomized study to investigate the clinical benefits of neoadjuvant chemotherapy for bulky stage I/II cervical cancer. Patients with FIGO stage I/II with bulky disease are randomized to either neoadjuvant chemotherapy (BOMP: Cisplatin 14mg/m2 day 1-5, Bleomycin 7mg day 1-5, Mitomycin 7mg/m2 day 5, and Vincristine 0.7mg/m2 day every 21 days for 2-4 cycles followed by radical hysterectomy or radical hysterectomy alone. The primary endpoint is overall survival and the secondary endpoints are progression-free survival, complication of surgery, completeness of radical hysterectomy, omission of postsurgical irradiation, completeness of postsurgical irradiation, response rate, and adverse events. A total 200 patients (100 per treatment arm) planned to accrue for this study within 5.5 years.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgery	Active Comparator		Procedure: radical hysterectomy
Chemotherapy + Surgery	Experimental		Drug: neoadjuvant chemotherapy + radical hysterectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
neoadjuvant chemotherapy + radical hysterectomy	Drug		Chemotherapy + Surgery
radical hysterectomy

Measure	Description	Time Frame
overall survival

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Untreated cervical cancer
Pathologically diagnosed squamous carcinoma
FIGO stage Ib2, IIa (>4cm), and IIb
Measurable lesions
Possible to radical hysterectomy
Age: 20 to 70 years
PS: 0 and 1
WBC > 3,000/mm3, Hb > 9.0g/dl, Platelet > 100,000 /mm3, SGOT/SGPT < 60 IU/L, T-Bil < 1.5 mg/dL, Cr < 1.2 mg/dL, PaO2 > 80 torr, normal ECG
Written informed consent

Exclusion Criteria:

Patients who have any evidence of the other cancer present within the last 5 years with the exception of carcinoma in situ or intramucosal cancer those are curable with local therapy
Women during pregnancy or breast-feeding
Patients with psychiatric illness
Patients who have active infection
Patients who have uncontrolled diabetes or uncontrolled hypertension
Patients who have positive HBs
Patients who have had heart failure, unstable angina, or myocardial infarction within the past 6 months
Patients with interstitial pneumonitis or pulmonary fibrosis
Patients who are unable to undergo radical hysterectomy for complication of excessive obesity, liver cirrhosis, or bleeding tendency

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Toshiharu Kamura, MD, PhD	Kurume University	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Center Hospital		Chuo-ku	Tokyo	1040045	Japan

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics

Measure	Description	Time Frame
progression-free survival
complication of surgery
completeness of radical hysterectomy