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

NCT ID: NCT03308591

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 774 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-11
• Study Completion Date: 2022-02-01

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.

Conditions

Uterine Cervical Neoplasm; Cervical Cancer; Uterine Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NACT

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.

Group Type: EXPERIMENTAL

NACT

Intervention Type: DRUG

Platin based chemotherapy

RT+PLND

Intervention Type: PROCEDURE

radical hysterectomy+pelvic lymphadenectomy

Adjuvant chemotherapy

Intervention Type: DRUG

Platin based chemotherapy

PST

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.

Group Type: ACTIVE_COMPARATOR

RT+PLND

Intervention Type: PROCEDURE

radical hysterectomy+pelvic lymphadenectomy

Adjuvant chemotherapy

Intervention Type: DRUG

Platin based chemotherapy

Interventions

NACT

Platin based chemotherapy

Intervention Type: DRUG

RT+PLND

radical hysterectomy+pelvic lymphadenectomy

Intervention Type: PROCEDURE

Adjuvant chemotherapy

Platin based chemotherapy

Intervention Type: DRUG

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;

• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Ding Ma

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ding Ma, MD PhD

Role: STUDY_CHAIR

Huazhong University of Science and Technology

Locations

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Countries

China

References

Hu Y, Han Y, Shen Y, Chen J, Chen Y, Chen Y, Tang J, Xue M, Hong L, Cheng W, Wang D, Liang Z, Wang Y, Zhang Q, Xing H, Zhang Y, Yi C, Yu Z, Chen Y, Cui M, Ma C, Yang H, Li R, Long P, Zhao Y, Qu P, Tao G, Yang L, Wu S, Liu Z, Yang P, Lv W, Xie X, Ma D, Wang H, Li K. Neoadjuvant chemotherapy for patients with international federation of gynecology and obstetrics stages IB3 and IIA2 cervical cancer: a multicenter prospective trial. BMC Cancer. 2022 Dec 5;22(1):1270. doi: 10.1186/s12885-022-10355-3.

Reference Type: DERIVED

PMID: 36471257 (View on PubMed)

Other Identifiers

CSEM GOG-005B

Identifier Type: -

Identifier Source: org_study_id