The Clinical Research of Neoadjuvant Chemotherapy Combined Surgery for Locally Advanced Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Optimization Research of Early Cervical Caner Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02471027
• Other study ID #: D151100001915001
• Status: Not yet recruiting
• Phase: N/A
• First received: May 28, 2015
• Last updated: June 11, 2015
• Start date: June 2015
• Est. completion date: June 2019

Study information

• Verified date: June 2015
• Source: Capital Medical University
• Contact: Yu M Wu, professor
• Phone: 13701016571
• Email: wym597118[@]163.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Observational [Patient Registry]

Clinical 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 directly.Main observation indexes is overall survival and disease-free survival.

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:

1. 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.

2. the quality of life assessment: including EQ-5D health index scale and FSFI scale.

3. the economics indexes: direct and indirect costs.

4. 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.

5. perioperative: operation time, intraoperative blood loss, postoperative complications, postoperative mortality, infections, etc.

6. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age greater than equal to 18

2. The initial treatment of cervical cancer,the Pathology is squamous cell carcinoma, adenocarcinoma and Adenosquamous carcinoma

3. 2009 FIGO clinical staging IB2, IIA2 stage cervical cancer

4. Patients acceptted the treatment of neoadjuvant chemotherapy combined cervical cancer radical surgery or cervical cancer radical surgery directly

5. Inform consent form

Exclusion Criteria:

1. With severe complications can not tolerate surgery, chemotherapy

2. Patients with distant metastasis

3. With uncontrolled seizures, central nervous system disease or a history of mental disorders, the researchers determine the clinical severity affect clinical research

4. The last five years has a history of other malignant diseases

5. Have received chemotherapy and radiotherapy patients

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Neoadjuvant chemotherapy
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.

Locations

Country	Name	City	State
China	Beijing Obstetrics and Gynecology Hospital, Capital Medical University	Beijing	Beijing

Sponsors (8)

Lead Sponsor	Collaborator
Yu mei Wu	Beijing Anzhen Hospital, Beijing Chao Yang Hospital, Beijing Shijitan Hospital, Chinese PLA General Hospital, Peking University First Hospital, Peking University People's Hospital, Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the quality of life assessment	Including EQ-5D health index scale and FSFI scale.	Before treatment and follow-up period.The average time is up to two year.	Yes
Other	High risk factors of relapse analysis	The high risk factors of relapse contain:lymgh node positive rate, cervical local tumor changes after neoadjuvant chemotherapy, pathologic complete response rate neoadjuvant chemotherapy, tumor pathology classification, tumor stromal infiltration depth, Cut edge positive rate, Vascular tumor emboli rate, etc.	We get the result after operation.The average time is up to one year.	Yes
Other	perioperative indexes	The perioperative indexes contain operation time, intraoperative blood loss, postoperative complications, postoperative mortality, etc.	The period of preoperative, intraoperative and postoperative.The average time is up to one year.	Yes
Other	Adverse reactions	Application WHO anti-cancer drug adverse reaction degree and RTOG/EORTC criteria to evaluate different treatment of adverse reactions.	The period of neoadjuvant chemotherapy and postoperative radiotherapy and chemotherapy.The average time is up to one year.	Yes
Primary	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.	The average time is up to four year.	Yes
Secondary	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.	The average time is up to three year.	Yes