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

This study has been terminated.

First Received: September 13, 2005 Last Updated: January 17, 2007 History of Changes

Sponsors and Collaborators:	Japan Clinical Oncology Group Japanese Ministry of Health, Labor and Welfare
Information provided by:	Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:	NCT00190528

Purpose

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

Condition	Intervention	Phase
Cervical Neoplasms	Drug: neoadjuvant chemotherapy + radical hysterectomy Procedure: radical hysterectomy	Phase III

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer Hysterectomy Surgery

U.S. FDA Resources

Further study details as provided by Japan Clinical Oncology Group:

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

Estimated Enrollment:	200
Study Start Date:	February 2002
Estimated Study Completion Date:	February 2009

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.

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190528

Locations

Japan, Tokyo
National Cancer Center Hospital
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 1040045

Sponsors and Collaborators

Japan Clinical Oncology Group

Japanese Ministry of Health, Labor and Welfare

Investigators

Study Chair:

Toshiharu Kamura, MD, PhD

Kurume University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	JCOG0102, C000000194
Study First Received:	September 13, 2005
Last Updated:	January 17, 2007
ClinicalTrials.gov Identifier:	NCT00190528 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:

cervical cancer
drug therapy
cisplatin

bleomycin
mitomycin
vincristine

Study placed in the following topic categories:

Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Cisplatin
Mitomycin
Genital Neoplasms, Female

Vincristine
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms
Mitomycins
Bleomycin

Additional relevant MeSH terms:

Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Neoplasms
Neoplasms by Site

Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on September 02, 2009