A Trial of Neoadjuvant Chemotherapy + Surgery vs. Surgery for Bulky Stage I/II Cervical Cancer
This study has been terminated.
Sponsor:
Haruhiko Fukuda
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Haruhiko Fukuda, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00190528
First received: September 13, 2005
Last updated: September 20, 2016
Last verified: September 2016
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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:
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
| Enrollment: | 200 |
| Study Start Date: | February 2002 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Surgery | Procedure: radical hysterectomy |
| Experimental: Chemotherapy + Surgery | Drug: neoadjuvant chemotherapy + radical hysterectomy |
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 (Adult, Senior) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00190528
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190528
Locations
| Japan | |
| National Cancer Center Hospital | |
| Chuo-ku, Tokyo, Japan, 1040045 | |
Sponsors and Collaborators
Haruhiko Fukuda
Ministry of Health, Labour and Welfare, Japan
Investigators
| Study Chair: | Toshiharu Kamura, MD, PhD | Kurume University |
More Information
Additional Information:
| Responsible Party: | Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00190528 History of Changes |
| Other Study ID Numbers: | JCOG0102 C000000194 |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 20, 2016 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Japan Clinical Oncology Group:
|
cervical cancer drug therapy cisplatin |
bleomycin mitomycin vincristine |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on September 28, 2016