A Trial of Neoadjuvant Chemotherapy + Surgery vs. Surgery for Bulky Stage I/II Cervical Cancer
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)
2 other identifiers
interventional
200
1 country
1
Brief Summary
To investigate the clinical benefits of neoadjuvant chemotherapy for bulky stage I/II cervical cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2002
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedSeptember 22, 2016
September 1, 2016
2.8 years
September 13, 2005
September 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
Secondary Outcomes (7)
progression-free survival
complication of surgery
completeness of radical hysterectomy
omission of postsurgical irradiation
completeness of postsurgical irradiation
- +2 more secondary outcomes
Study Arms (2)
Surgery
ACTIVE COMPARATORChemotherapy + Surgery
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Haruhiko Fukudalead
- Ministry of Health, Labour and Welfare, Japancollaborator
Study Sites (1)
National Cancer Center Hospital
Chuo-ku, Tokyo, 1040045, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Toshiharu Kamura, MD, PhD
Kurume University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- JCOG Data Center
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 19, 2005
Study Start
February 1, 2002
Primary Completion
December 1, 2004
Study Completion
February 1, 2009
Last Updated
September 22, 2016
Record last verified: 2016-09