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

NCT03308591 — Phase 3, Completed, 774 participants, Huazhong University of Science and Technology

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

Registry	NCT03308591
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	774 (Actual)
Sponsor	Huazhong University of Science and Technology (Other)
Conditions	Uterine Cervical Neoplasm, Cervical Cancer, Uterine Cervical Cancer
Interventions	NACT, RT+PLND, Adjuvant chemotherapy (Drug, procedure)
Dates	start 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 in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
NACT	Experimental	Drug: NACT; Procedure: RT+PLND; Drug: Adjuvant chemotherapy	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.
PST	Active comparator	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.

NACT (Drug): Platin based chemotherapy
RT+PLND (Procedure): radical hysterectomy+pelvic lymphadenectomy
Adjuvant chemotherapy (Drug): Platin based chemotherapy

+Outcome measures

Primary outcomes

disease-free survival (DFS) of the neoadjuvant chemotherapy Group [Up to 3-year]: 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.

Secondary outcomes

DSF of the synchro-chemoradiotheraphy group [Up to 3-year]

Other outcomes

chemotherapy- and radiotherapy- related adverse effects respectively in two groups [Up to 3-year]

+Eligibility

Sex: Female, ages: any to 65 Years

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;

+Locations (1)

Facility	City	Country	Status
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan, Hubei	China

+Publications

Results publication: 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. PMID 36471257

+Investigators

Ding Ma, MD PhD, Study chair, Huazhong University of Science and Technology

My Notes

Public

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