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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Uterine Cervical Neoplasm, Cervical Cancer, Uterine Cervical Cancer

Intervention / Treatment
-----------------
* Drug: NACT
* Procedure: RT+PLND
* Drug: Adjuvant chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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;

Ages Eligible for Study
-----------------
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NACT<br>The patients will receive 2 courses of platinum based chemotherapy before surgery, 2-3 weeks after each course, doctors will appraise the effect of the chemotherapy. Patients who are sensitive to the treatment will undergo radical hysterectomy and pelvic lymph node dissection 3 weeks after chemotherapy. And 2-3weeks after the surgery, patients will receive adjuvant chemotherapy according to the pathological risk factors. | Drug: NACT<br>* Platin based chemotherapy<br>Procedure: RT+PLND<br>* radical hysterectomy+pelvic lymphadenectomy<br>Drug: Adjuvant chemotherapy<br>* Platin based chemotherapy<br>|
| Active Comparator: PST<br>The patients in this group will undergo radical hysterectomy and pelvic lymph node dissection directly, and 2-6 weeks after the surgery, they will receive adjuvant chemotherapy according to the pathological risk factors. | Procedure: RT+PLND<br>* radical hysterectomy+pelvic lymphadenectomy<br>Drug: Adjuvant chemotherapy<br>* Platin based chemotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DSF of the synchro-chemoradiotheraphy group |  | Up to 3-year |