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

Cervical Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00190528
• Other study ID #: JCOG0102
• Secondary ID: C000000194
• Status: Terminated
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 20, 2016
• Start date: February 2002
• Est. completion date: February 2009

Study information

• Verified date: September 2016
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: February 2009
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cervical Neoplasms
• Uterine Cervical Neoplasms

Intervention

Drug:
• neoadjuvant chemotherapy + radical hysterectomy

Procedure:
• radical hysterectomy

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Haruhiko Fukuda	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival
Secondary	progression-free survival
Secondary	complication of surgery
Secondary	completeness of radical hysterectomy
Secondary	omission of postsurgical irradiation
Secondary	completeness of postsurgical irradiation
Secondary	response rate
Secondary	adverse events

External Links

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