Clinical trial NCT00190528: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cervical Neoplasms
Keywords: cervical cancer
drug therapy
cisplatin
bleomycin
mitomycin
vincristine
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-09-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

1. 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

Exclusion Criteria:

1. 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 infection
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

Primary outcomes:
measure: overall survival
Secondary outcomes:
measure: progression-free survival
measure: complication of surgery
measure: completeness of radical hysterectomy
measure: omission of postsurgical irradiation
measure: completeness of postsurgical irradiation
measure: response rate
measure: adverse events
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
Study officials:
affiliation: Kurume University
name: Toshiharu Kamura, MD, PhD
role: STUDY_CHAIR
References: