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

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer; Uterine Cervical Cancer; Uterine Cervical Neoplasm
• Intervention / Treatment: Drug: NACT; Procedure: RT+PLND; Drug: Adjuvant chemotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ding Ma, MD PhD

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology
      • Contact: Ding Ma, MD PhD; Email: dma@tjh.tjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: NACT; Platin based chemotherapy; Procedure: RT+PLND; radical hysterectomy+pelvic lymphadenectomy; Drug: Adjuvant chemotherapy; Platin based chemotherapy
Active Comparator: 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.	Procedure: RT+PLND; radical hysterectomy+pelvic lymphadenectomy; Drug: Adjuvant chemotherapy; Platin based chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 3-year

Secondary Outcome Measures

Outcome Measure	Time Frame
DSF of the synchro-chemoradiotheraphy group	Up to 3-year

Other Outcome Measures

Outcome Measure	Time Frame
chemotherapy- and radiotherapy- related adverse effects respectively in two groups	Up to 3-year

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Study Chair: Ding Ma, MD PhD, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): April 30, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: October 8, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (Actual): October 12, 2017

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: CSEM GOG-005B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No