A Phase 3 interventional study of NACT and RT+PLND in Uterine Cervical Neoplasm, Cervical Cancer and Uterine Cervical Cancer, sponsored by Huazhong University of Science and Technology. Completed at 1 site in China. Open to female participants aged Up to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by Huazhong University of Science and Technology · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
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 · Procedure: RT+PLND · Drug: Adjuvant chemotherapy
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 · Drug: Adjuvant chemotherapy
Platin based chemotherapy
radical hysterectomy+pelvic lymphadenectomy
Platin based chemotherapy
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.
Time frame: Up to 3-year
DSF of the synchro-chemoradiotheraphy group
Time frame: Up to 3-year
chemotherapy- and radiotherapy- related adverse effects respectively in two groups
Time frame: Up to 3-year
Plan to share: Undecided — The individual participants data will be preserved in the hospital, and all the chemical or physical examination results will be kept in the medical records, the researches, ethics committee and the drug administration will be permitted to look up all the records as we planned. And all the reports or papers about this research will not relate to the patients' identity. But we do not decide whether the information be available to others, the final decision maybe decided by all the patients in this research.
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Huazhong University of Science and Technology