Clinical Efficacy of the Neoadjuvant Chemotherapy for IB2 and IIA2 Stage Cervical Cancer Patients

Cervical Cancer Clinical Trial

Official title:

Clinical Efficacy of the Neoadjuvant Chemotherapy for IB2 and IIA2 Stage Cervical Cancer Patients, A Multicenter, Prospective and Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03308591
• Other study ID #: CSEM GOG-005B
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2019
• Source: Huazhong University of Science and Technology
• Contact: Ding Ma, MD PhD
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In recent years, the patients with IB2 and IIA2 stage cervical cancer are still treated with radiotherapy and chemotherapy based treatment, but the radiotherapy will severely damage the function of ovary, cause endocrine dyscrasia and the sexual function of vagina. So we want to study whether neoadjuvant chemotherapy without radiotherapy will achieve the same outcome compared with traditional therapy including radiotherapy. So we randomly divide IB2 and IIA2 stage cervical cancer patients into two groups. The neoadjuvant chemotherapy group will receive two courses of chemotherapy basically composed of platinum, and then undergo surgery, after that, doctors will add more courses of chemotherapy according to the situations of the patients, including whether the patients have the adverse prognostic factors. The control group will undergo surgery directly, and then receive chemotherapy and radiotherapy at the same time. Then we will compare the outcomes of these two groups, and analyze the therapeutic effect, the impact on survival rate and the effect on improving the living quality of patient from two groups. All the outcomes will be fed back to clinical doctors and instruct them to choose better treatment for patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2020
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 65 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis IB2 or IIA2 stage cervical cancer;

• age less than or equal to 65 years old;

• laboratory examination results: WBC = 4*10^9/L, NEU = 20*10^9/L, PLT = 80*10^9/L, serum bilirubin = 2 multiples of the upper normal limit, aminopherase = 2 multiples of the upper normal limit. BUN = normal limit, CR = normal limit;

• KARNOFSKY score = 60;

• No prior treatment;

• pathological diagnosis before surgery is invasive squamous cell carcinoma of cervix;

• well-compliance and willing to keep in touch;

• willing to participate in this study, and sign the informed consent;

Exclusion Criteria:

• participate in other drug clinical trials at the same time;

• respiratory depression, airway obstruction and hypoxia;

• heart diseases (cardiac function at grade II, III or above);

• hematological diseases;

• obvious dysfunction of liver and kidney (above 3 multiples of the upper normal limit);

• a history of brain dysfunction;

• unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy;

• drug abuse or a history of drug abuse;

• unable or unwilling to sign informed consents;

• unable or unwilling to follow the protocols;

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Cancer
• Uterine Cervical Neoplasm
• Uterine Cervical Neoplasms

Intervention

Drug:
• NACT
Platin based chemotherapy

Procedure:
• RT+PLND
radical hysterectomy+pelvic lymphadenectomy

Drug:
• Adjuvant chemotherapy
Platin based chemotherapy

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	chemotherapy- and radiotherapy- related adverse effects respectively in two groups		Up to 3-year
Primary	disease-free survival (DFS) of the neoadjuvant chemotherapy Group	DFS was definite as the time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence.	Up to 3-year
Secondary	DSF of the synchro-chemoradiotheraphy group		Up to 3-year