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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Neoplasms | Drug: neoadjuvant chemotherapy + radical hysterectomy Procedure: radical hysterectomy | Phase 3 |
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 |
Actual Primary Completion Date : | December 2004 |
Actual Study Completion Date : | February 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Surgery |
Procedure: radical hysterectomy |
Experimental: Chemotherapy + Surgery |
Drug: neoadjuvant chemotherapy + radical hysterectomy |
- overall survival
- progression-free survival
- complication of surgery
- completeness of radical hysterectomy
- omission of postsurgical irradiation
- completeness of postsurgical irradiation
- response rate
- adverse events

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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
Japan | |
National Cancer Center Hospital | |
Chuo-ku, Tokyo, Japan, 1040045 |
Study Chair: | Toshiharu Kamura, MD, PhD | Kurume University |
Responsible Party: | Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group |
ClinicalTrials.gov Identifier: | NCT00190528 |
Other Study ID Numbers: |
JCOG0102 C000000194 |
First Posted: | September 19, 2005 Key Record Dates |
Last Update Posted: | September 22, 2016 |
Last Verified: | September 2016 |
cervical cancer drug therapy cisplatin |
bleomycin mitomycin vincristine |
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |