Specific Molecular Signatures Predict Neoadjuvant Chemotherapy Response in Cervical Cancer

NCT03229187UNKNOWNOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Huazhong University of Science and Technology

Enrollment

240

Start Date

2016-01-01

Completion Date

2020-09-30

Study Type

OBSERVATIONAL

Official Title

Accurate Prediction and Validation of Response to Neoadjuvant Chemotherapy in Cervical Cancer

Conditions

Uterine Cervical NeoplasmsCervical CancerUterine Cervical Cancer

Eligibility

Age Range

18 Years – 70 Years

Sex

FEMALE

Inclusion Criteria:

* Untreated cervical cancer with FIGO stage Ib-IIb
* Measurable lesions
* Possible to radical hysterectomy
* Age: 18 and older
* Karnofsky Performance Status≥ 70.
* WBC \> 3,000/mm³, Hb \> 9.0g/dl, Platelet \> 100,000 /mm³, SGOT/SGPT \< 60 IU/L, T-Bil \< 1.5 mg/dL, Cr \< 1.2 mg/dL, PaO2 \> 80 torr, normal ECG
* Written informed consent

Exclusion Criteria:

* Previous history of cancer
* Patients with previous treatment
* Patients without information of clinical risk factors
* Patients who have active infection

Outcome Measures

Primary Outcomes

The clinical response to neoadjuvant chemotherapy

clinical response(tumor size)

Time frame: 1 to 3 months

Secondary Outcomes

The pathological response to neoadjuvant chemotherapy

pathological response(\<3 mm or not)

Time frame: 1 to 3 months

Locations

Tongji Hospital, Wuhan, China

Specific Molecular Signatures Predict Neoadjuvant Chemotherapy Response in Cervical Cancer