Trial | NCT00190528  Report issue

Title

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)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    200
To investigate the clinical benefits of neoadjuvant chemotherapy for bulky stage I/II cervical cancer
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.
Study Started
Feb 28
2002
Primary Completion
Dec 31
2004
Study Completion
Feb 28
2009
Last Update
Sep 22
2016
Estimate

Drug neoadjuvant chemotherapy + radical hysterectomy

Procedure radical hysterectomy

Surgery Active Comparator

Chemotherapy + Surgery Experimental

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
No Results Posted