NCT03308591

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 774 (actual)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	NACT	Platin based chemotherapy
PROCEDURE	RT+PLND	radical hysterectomy+pelvic lymphadenectomy
DRUG	Adjuvant chemotherapy	Platin based chemotherapy

Timeline

• Start date: 2016-01-11
• Primary completion: 2022-02-01
• Completion: 2022-02-01
• First posted: 2017-10-12
• Last updated: 2024-10-31

Locations

1 site across 1 country: China