Text Size

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

This study has been terminated.
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00190528
First received: September 13, 2005
Last updated: January 17, 2007
Last verified: September 2005
History of Changes

September 13, 2005
January 17, 2007
February 2002
Not Provided
overall survival
Same as current
Complete list of historical versions of study NCT00190528 on ClinicalTrials.gov Archive Site
  • progression-free survival
  • complication of surgery
  • completeness of radical hysterectomy
  • omission of postsurgical irradiation
  • completeness of postsurgical irradiation
  • response rate
  • adverse events
Same as current
Not Provided
Not Provided
 
A Trial of Neoadjuvant Chemotherapy + Surgery vs. Surgery for Bulky Stage I/II Cervical Cancer
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)

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

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Cervical Neoplasms
  • Drug: neoadjuvant chemotherapy + radical hysterectomy
  • Procedure: radical hysterectomy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
February 2009
Not Provided

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
Female
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00190528
JCOG0102, C000000194
Not Provided
Not Provided
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Study Chair: Toshiharu Kamura, MD, PhD Kurume University
Japan Clinical Oncology Group
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP