Clinical trial NCT03308591: Clinical Efficacy of the Neoadjuvant Chemotherapy for IB2 and IIA2 Stage Cervical Cancer Patients
Official title: Clinical Efficacy of the Neoadjuvant Chemotherapy for IB2 and IIA2 Stage Cervical Cancer Patients, A Multicenter, Prospective and Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Cervical Neoplasm
Cervical Cancer
Uterine Cervical Cancer
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 774
Sex: FEMALE
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: disease-free survival (DFS) of the neoadjuvant chemotherapy Group
timeFrame: Up to 3-year
Secondary outcomes:
measure: DSF of the synchro-chemoradiotheraphy group
timeFrame: Up to 3-year
Other outcomes:
measure: chemotherapy- and radiotherapy- related adverse effects respectively in two groups
timeFrame: Up to 3-year
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Ding Ma, MD PhD
role: STUDY_CHAIR
References: