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

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ClinicalTrials.gov Identifier: NCT03308591
Recruitment Status : Recruiting
First Posted : October 12, 2017
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Ding Ma, Huazhong University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Uterine Cervical Neoplasm Cervical Cancer Uterine Cervical Cancer Drug: NACT Procedure: RT+PLND Drug: Adjuvant chemotherapy Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of the Neoadjuvant Chemotherapy for IB2 and IIA2 Stage Cervical Cancer Patients, A Multicenter, Prospective and Randomized Controlled Trial
Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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




Primary Outcome Measures :
  1. disease-free survival (DFS) of the neoadjuvant chemotherapy Group [ Time Frame: 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 Outcome Measures :
  1. DSF of the synchro-chemoradiotheraphy group [ Time Frame: Up to 3-year ]

Other Outcome Measures:
  1. chemotherapy- and radiotherapy- related adverse effects respectively in two groups [ Time Frame: Up to 3-year ]


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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308591


Contacts
Contact: Ding Ma, MD PhD

Locations
China, Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Ding Ma, MD PhD       dma@tjh.tjmu.edu.cn   
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
Study Chair: Ding Ma, MD PhD Huazhong University of Science and Technology

Responsible Party: Ding Ma, chief physician, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03308591     History of Changes
Other Study ID Numbers: CSEM GOG-005B
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female