Back to resultsA Trial of Neoadjuvant Chemotherapy + Surgery vs. Surgery for Bulky Stage I/II Cervical Cancer
Primary Purpose
Cervical Neoplasms
Status
Terminated
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
neoadjuvant chemotherapy + radical hysterectomy
radical hysterectomy
Sponsored by
About this trial
This is an interventional diagnostic trial for Cervical Neoplasms focused on measuring cervical cancer, drug therapy, cisplatin, bleomycin, mitomycin, vincristine
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
Sites / Locations
- National Cancer Center Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Surgery
Chemotherapy + Surgery
Arm Description
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
progression-free survival
complication of surgery
completeness of radical hysterectomy
omission of postsurgical irradiation
completeness of postsurgical irradiation
response rate
adverse events
Full Information
NCT ID
NCT00190528
First Posted
September 13, 2005
Last Updated
September 20, 2016
Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan
1. Study Identification
Unique Protocol Identification Number
NCT00190528
Brief Title
A Trial of Neoadjuvant Chemotherapy + Surgery vs. Surgery for Bulky Stage I/II Cervical Cancer
Official Title
Phase III Trial of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Bulky Stage I/II Cervical Cancer: Japan Clinical Oncology Group Trial (JCOG0102)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Study Start Date
February 2002 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Neoplasms
Keywords
cervical cancer, drug therapy, cisplatin, bleomycin, mitomycin, vincristine
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgery
Arm Type
Active Comparator
Arm Title
Chemotherapy + Surgery
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
neoadjuvant chemotherapy + radical hysterectomy
Intervention Type
Procedure
Intervention Name(s)
radical hysterectomy
Primary Outcome Measure Information:
Title
overall survival
Secondary Outcome Measure Information:
Title
progression-free survival
Title
complication of surgery
Title
completeness of radical hysterectomy
Title
omission of postsurgical irradiation
Title
completeness of postsurgical irradiation
Title
response rate
Title
adverse events
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshiharu Kamura, MD, PhD
Organizational Affiliation
Kurume University
Official's Role
Study Chair
Facility Information:
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
1040045
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://www.jcog.jp/
Description
Related Info
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A Trial of Neoadjuvant Chemotherapy + Surgery vs. Surgery for Bulky Stage I/II Cervical Cancer
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