NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000194

Registered date:12/09/2005

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)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPatients with cervical cancer
Date of first enrollment2002/02/01
Target sample size200
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)A: neoadjuvant chemotherapy + radical hysterectomy B: Radical hysterectomy

Outcome(s)

Primary Outcomeoverall survival
Secondary Outcomeprogression-free survival, complication of surgery, completeness of radical hysterectomy, ommission of postsurgical irradiation, completeness of postsurgical irradiation, response rate, adverse events

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
GenderFemale
Include criteria1) Untreated cervical cancer 2) Pathologically diagnosed squamous carcinoma 3) FIGO stage Ib2, IIa (>4cm), and IIb 4) Measurable lesions 5) Possible to radical hysterectomy 6) Age: 20 to 70 years 7) PS: 0 and 1 8) 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 9) Written informed consent
Exclude criteria1) 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 2) Women during pregnancy or breast-feeding 3) Patients with psychiatric illness 4) Patients who have active infectoin 5) Patients who have uncontrolled diabetes or uncontrolled hypertension 6) Patients who have positive HBs 7) Patients who have had heart failure, unstable angina, or myocardial infarction within the past 6 months 8) Patients with interstitial pneumonitis or pulmonary fibrosis 9) Patients who are unable to undergo radical hysterectomy for complication of excessive obesity, liver cirrhosis, or bleeding tendency

Related Information

Contact

public contact
Name Noriyuki Katsumata ,MD
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN Japan
Telephone
E-mail JCOG_sir@ml.jcog.jp
Affiliation JCOG0102 Coordinating Office Medical Oncology Division, National Cancer Center Hospital
scientific contact
Name Toshiharu Kamura, MD, PhD
Address 67 Asahi-machi, Kurume-city, Fukuoka Prefecture 830-0011, JAPAN Japan
Telephone
E-mail
Affiliation Kurume University Obstetrics and Gynecology