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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00190528
Recruitment Status : Terminated
First Posted : September 19, 2005
Last Update Posted : September 22, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To investigate the clinical benefits of neoadjuvant chemotherapy for bulky stage I/II cervical cancer

Condition or disease Intervention/treatment Phase
Cervical Neoplasms Drug: neoadjuvant chemotherapy + radical hysterectomy Procedure: radical hysterectomy Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : February 2002
Primary Completion Date : December 2004
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Surgery Procedure: radical hysterectomy
Experimental: Chemotherapy + Surgery Drug: neoadjuvant chemotherapy + radical hysterectomy


Outcome Measures

Primary Outcome Measures :
  1. overall survival

Secondary Outcome Measures :
  1. progression-free survival
  2. complication of surgery
  3. completeness of radical hysterectomy
  4. omission of postsurgical irradiation
  5. completeness of postsurgical irradiation
  6. response rate
  7. adverse events

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016

Keywords provided by Haruhiko Fukuda, 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