Cervical NeoplasmsPhase 3NCT00190528
A Trial of Neoadjuvant Chemotherapy + Surgery vs. Surgery for Bulky Stage I/II Cervical Cancer
A Phase 3 study testing neoadjuvant chemotherapy + radical hysterectomy and radical hysterectomy in people with Cervical Neoplasms, run by Haruhiko Fukuda at 1 site in Japan.
Trial summary
To investigate the clinical benefits of neoadjuvant chemotherapy for bulky stage I/II cervical cancer Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Cervical Neoplasms
- What is being tested?
- neoadjuvant chemotherapy + radical hysterectomy and radical hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2002to Feb 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
To investigate the clinical benefits of neoadjuvant chemotherapy for bulky stage I/II cervical cancer
Read the 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.
- Conditions
- Cervical Neoplasms
- Being tested
- neoadjuvant chemotherapy + radical hysterectomy, radical hysterectomy
- Keywords
- cervical cancer, drug therapy, cisplatin, bleomycin, mitomycin, vincristine
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant chemotherapy + radical hysterectomyDrug
radical hysterectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Active comparator | Not described Receives: Procedure: radical hysterectomy |
| Chemotherapy + Surgery | Experimental | Not described Receives: Drug: neoadjuvant chemotherapy + radical hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Secondary outcomes (7)
progression-free survival
complication of surgery
completeness of radical hysterectomy
omission of postsurgical irradiation
completeness of postsurgical irradiation
response rate
adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startFeb 2002
- Primary completionDec 2004
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haruhiko Fukuda
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Responsible party
- Sponsor-investigator, Haruhiko Fukuda, Japan Clinical Oncology Group
- Investigators
- Toshiharu Kamura, MD, PhD, Study chair, Kurume University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190528
- Sponsor's protocol ID
- JCOG0102
- Other IDs
- C000000194
- Status last verified
- Sep 2016
- First submitted
- 13 Sep 2005
- Last updated
- 22 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00190528
- Acronym / sponsor ID
- JCOG0102
- Conditions
- Cervical Neoplasms
- Keywords
- cervical cancer, drug therapy, cisplatin, bleomycin, mitomycin, vincristine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Haruhiko FukudaUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Feb 2002
- Primary completion
- Dec 2004 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the clinical benefits of neoadjuvant chemotherapy for bulky stage I/II cervical cancer
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Active comparator | Procedure: radical hysterectomy |
| Chemotherapy + Surgery | Experimental | Drug: neoadjuvant chemotherapy + radical hysterectomy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Untreated cervical cancer
- Pathologically diagnosed squamous carcinoma
- FIGO stage Ib2, IIa (>4cm), and IIb
- Measurable lesions
- Possible to radical hysterectomy
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neoadjuvant chemotherapy + radical hysterectomy | Drug | Chemotherapy + Surgery |
| radical hysterectomy | Procedure or surgery | Surgery |
Primary outcome
overall survival
7 secondary outcomes
progression-free survival
complication of surgery
completeness of radical hysterectomy
omission of postsurgical irradiation
completeness of postsurgical irradiation
response rate
adverse events
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toshiharu Kamura, MD, PhD study chair
Kurume University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing neoadjuvant chemotherapy + radical hysterectomy and radical hysterectomy in people with Cervical Neoplasms, run by Haruhiko Fukuda at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2016.