Status:

COMPLETED

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

Lead Sponsor:

Huazhong University of Science and Technology

Conditions:

Uterine Cervical Neoplasm

Cervical Cancer

Eligibility:

FEMALE

Up to 65 years

Phase:

PHASE3

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 ov...

Eligibility Criteria

Inclusion

  • 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

  • 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;

Key Trial Info

Start Date :

January 11 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2022

Estimated Enrollment :

774 Patients enrolled

Trial Details

Trial ID

NCT03308591

Start Date

January 11 2016

End Date

February 1 2022

Last Update

October 31 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China, 430030