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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
  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:

U.S. FDA Resources

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

Estimated Enrollment: 200
Study Start Date: February 2002
Estimated Study Completion Date: February 2009
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
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190528

Locations
Japan
National Cancer Center Hospital
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 1040045
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Toshiharu Kamura, MD, PhD Kurume University
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00190528     History of Changes
Other Study ID Numbers: JCOG0102, C000000194
Study First Received: September 13, 2005
Last Updated: January 17, 2007
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:
Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 23, 2013