Cervical CancerNCT02471027
The Clinical Research of Neoadjuvant Chemotherapy Combined Surgery for Locally Advanced Cervical Cancer
An observational study of Cervical Cancer, run by Yu mei Wu at 1 site in China.
Trial summary
This study is a registration study.The main research: the curative effect of neoadjuvant chemotherapy in the treatment of ⅠB2 and ⅡA2 locally advanced cervical cancer.Research group: the neoadjuvant chemotherapy in combination with cervical cancer radical hysterectomy.Control group:cervical cancer radical hysterectomy… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Neoadjuvant chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Jun 2019
- How long will I take part?
- 4 Years
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 2009 FIGO clinical staging IB2, IIA2 stage cervical cancer.
Who may be able to join
- Age greater than equal to 18
- The initial treatment of cervical cancer,the Pathology is squamous cell carcinoma, adenocarcinoma and Adenosquamous carcinoma
- 2009 FIGO clinical staging IB2, IIA2 stage cervical cancer
- Patients acceptted the treatment of neoadjuvant chemotherapy combined cervical cancer radical surgery or cervical cancer radical surgery directly
- Inform consent form
Who cannot join
- With severe complications can not tolerate surgery, chemotherapy
- Patients with distant metastasis
- With uncontrolled seizures, central nervous system disease or a history of mental disorders, the researchers determine the clinical severity affect clinical research
- The last five years has a history of other malignant diseases
- Have received chemotherapy and radiotherapy patients
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
About this study
Official title: Optimization Research of Early Cervical Caner Treatment
This study is a registration study.The main research: the curative effect of neoadjuvant chemotherapy in the treatment of ⅠB2 and ⅡA2 locally advanced cervical cancer.Research group: the neoadjuvant chemotherapy in combination with cervical cancer radical hysterectomy.Control group:cervical cancer radical hysterectomy directly.Main observation indexes is overall survival and disease-free survival.
Read the detailed description
This study is a multicenter registered study.Selected January 1, 2009 to June 31,2016 ,accepted neoadjuvant chemotherapy combined radical surgery or radical surgery directly as treatment,ⅠB2 and ⅡA2 stage cervical cancer patients at each center to participate in research. Total number of patients is at least 1000 cases.On January 1, 2009 to May 31, 2015 ,collected the baseline data and follow-up information of hospitalized patients ,called a retrospective group.On June 1，2015 to May 31，2016,all the cases into the group take prospective way to collect baseline data (called a prospective group).Mainly collect the follow-up information.
1.The main observation indexes: the overall survival (OS) : the time from treatment for the first time (first day of neoadjuvant chemotherapy or surgery) calculation to the time of death or the time of the last follow-up still alive(about four year).
2.Secondary outcome:
- 3 year disease-free survival (DFS) : from the operation time or neoadjuvant chemotherapy time calculation for the first time to recurrence/the time or the last follow-up time of death.
- the quality of life assessment: including EQ-5D health index scale and FSFI scale.
- the economics indexes: direct and indirect costs.
- High risk factors of the relapse analysis: lymph node positive rate, cervical local tumor changes after neoadjuvant chemotherapy, pathologic complete response rate after neoadjuvant chemotherapy, tumor pathology classification, tumor stromal infiltration depth, Cut edge positive rate, Vascular infiltration clearance rate, etc.
- perioperative: operation time, intraoperative blood loss, postoperative complications, postoperative mortality, infections, etc.
- adverse reactions (prospectie cohort study only) : application WHO anti-cancer drug adverse reaction degree and RTOG/EORTC criteria to evaluate different treatment of adverse reactions.
Subject of supervision organization for clinical research institute is Peking University Clinical Research Institute.
- Conditions
- Cervical Cancer
- Being tested
- Neoadjuvant chemotherapy
- Keywords
- Locally advanced cervical cancer, Neoadjuvant chemotherapy, Disease-free survival, Overall survival
- 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 chemotherapyProcedure or surgery
There is no uniform schemer,commonly used drugs including carboplatin,cisplatin,paclitaxel,vincristine,bleomycin,fluorouracil,ifosfamide,mitomycin,gemcitabine,and so on.Methods including intravenous chemotherapy and artery intervention chemotherapy,also has not been unified.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | 2009 FIGO staging ⅠB2 or ⅡA2，the treatment is neoadjuvant chemotherapy combined with cervical cancer radical surgery . Receives: Procedure: Neoadjuvant chemotherapy | |
| control group | 2009 FIGO staging ⅠB2 or ⅡA2，the treatment is cervical cancer radical surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
The time from treatment for the first time (first day of neoadjuvant chemotherapy or surgery) calculation to the time of death or the time of the last follow-up(In December 2019) still alive.
Measured: The average time is up to four year.
Secondary outcomes (1)
3 year disease-free survival (DFS)
From the operation time or neoadjuvant chemotherapy time calculation for the first time to recurrence/the time of death or the last follow-up time.
Measured: The average time is up to three year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies 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
- Observational
- Observational model
- Case-control
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Yu mei Wu
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Peking University Third Hospital, Chinese PLA General Hospital, Beijing Chao Yang Hospital, Beijing Anzhen Hospital, Beijing Shijitan Hospital, Capital Medical University, Peking University People's Hospital
- Responsible party
- Sponsor-investigator, Yu mei Wu, Capital Medical University
- Investigators
- Yu M Wu, professor, Principal investigator, Beijing obstetrics and geynecology hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471027
- Sponsor's protocol ID
- D151100001915001
- Status last verified
- Jun 2015
- First submitted
- 28 May 2015
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization Research of Early Cervical Caner Treatment
- ClinicalTrials.gov ID
- NCT02471027
- Acronym / sponsor ID
- D151100001915001
- Conditions
- Cervical Cancer
- Keywords
- Locally advanced cervical cancer, Neoadjuvant chemotherapy, Disease-free survival, Overall survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Yu mei WuUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Peking University Third Hospital, Chinese PLA General Hospital, Beijing Chao Yang Hospital, Beijing Anzhen Hospital, Beijing Shijitan Hospital, Capital Medical University, Peking University People's Hospital
- Study start
- Jun 2015
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 12 Jun 2015 (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.
This study is a registration study.The main research: the curative effect of neoadjuvant chemotherapy in the treatment of ⅠB2 and ⅡA2 locally advanced cervical cancer.Research group: the neoadjuvant chemotherapy in combination with cervical cancer radical hysterectomy.Control group:cervical cancer radical hysterectomy directly.Main observation indexes is overall survival and disease-free survival.
Detailed description
This study is a multicenter registered study.Selected January 1, 2009 to June 31,2016 ,accepted neoadjuvant chemotherapy combined radical surgery or radical surgery directly as treatment,ⅠB2 and ⅡA2 stage cervical cancer patients at each center to participate in research. Total number of patients is at least 1000 cases.On January 1, 2009 to May 31, 2015 ,collected the baseline data and follow-up information of hospitalized patients ,called a retrospective group.On June 1，2015 to May 31，2016,all the cases into the group take prospective way to collect baseline data (called a prospective group).Mainly collect the follow-up information.
1.The main observation indexes: the overall survival (OS) : the time from treatment for the first time (first day of neoadjuvant chemotherapy or surgery) calculation to the time of death or the time of the last follow-up still alive(about four year).
2.Secondary outcome:
- 3 year disease-free survival (DFS) : from the operation time or neoadjuvant chemotherapy time calculation for the first time to recurrence/the time or the last follow-up time of death.
- the quality of life assessment: including EQ-5D health index scale and FSFI scale.
- the economics indexes: direct and indirect costs.
- High risk factors of the relapse analysis: lymph node positive rate, cervical local tumor changes after neoadjuvant chemotherapy, pathologic complete response rate after neoadjuvant chemotherapy, tumor pathology classification, tumor stromal infiltration depth, Cut edge positive rate, Vascular infiltration clearance rate, etc.
- perioperative: operation time, intraoperative blood loss, postoperative complications, postoperative mortality, infections, etc.
- adverse reactions (prospectie cohort study only) : application WHO anti-cancer drug adverse reaction degree and RTOG/EORTC criteria to evaluate different treatment of adverse reactions.
Subject of supervision organization for clinical research institute is Peking University Clinical Research Institute.
Study design
- Observational model
- Case-control
- Target follow-up
- 4 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Procedure: Neoadjuvant chemotherapy2009 FIGO staging ⅠB2 or ⅡA2，the treatment is neoadjuvant chemotherapy combined with cervical cancer radical surgery . |
| control group | – | –2009 FIGO staging ⅠB2 or ⅡA2，the treatment is cervical cancer radical surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 2009 FIGO clinical staging IB2, IIA2 stage cervical cancer.
Key inclusion criteria (5 listed)
- Age greater than equal to 18
- The initial treatment of cervical cancer,the Pathology is squamous cell carcinoma, adenocarcinoma and Adenosquamous carcinoma
- 2009 FIGO clinical staging IB2, IIA2 stage cervical cancer
- Patients acceptted the treatment of neoadjuvant chemotherapy combined cervical cancer radical surgery or cervical cancer radical surgery directly
- Inform consent form
Key exclusion criteria (5 listed)
- With severe complications can not tolerate surgery, chemotherapy
- Patients with distant metastasis
- With uncontrolled seizures, central nervous system disease or a history of mental disorders, the researchers determine the clinical severity affect clinical research
- The last five years has a history of other malignant diseases
- Have received chemotherapy and radiotherapy patients
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 chemotherapyThere is no uniform schemer,commonly used drugs including carboplatin,cisplatin,paclitaxel,vincristine,bleomycin,fluorouracil,ifosfamide,mitomycin,gemcitabine,and so on.Methods including intravenous chemotherapy and artery intervention chemotherapy,also has not been unified. | Procedure or surgery | Experimental group |
Primary outcome
overall survival
Time frame: The average time is up to four year.
The time from treatment for the first time (first day of neoadjuvant chemotherapy or surgery) calculation to the time of death or the time of the last follow-up(In December 2019) still alive.
1 secondary outcome
3 year disease-free survival (DFS)
Time frame: The average time is up to three year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
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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.
Yu M Wu, professor principal investigator
Beijing obstetrics and geynecology hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by Yu mei Wu at 1 site in China.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Jun 2015. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu M Wu, professor (13701016571, wym597118@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: The average time is up to four year.). 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 12 Jun 2015.