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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03963882
Other study ID # NACC
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 19, 2019
Est. completion date June 1, 2025

Study information

Verified date June 2019
Source Peking Union Medical College Hospital
Contact Lei Li, M.D.
Phone +8613911988831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This cohort study is to evaluate the role of neoadjuvant chemotherapy (NAC) in the treatment of locally advanced cervical cancer (LACC). Sixty patients with LACC (FIGO 2009 stage IB2 to IIB) will be enrolled. After informed consents, they would accept the imaging evaluation of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET). After excluding cases of distant metastasis, they will accept two cycles of NAC (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks). Then a second MRI is performed to evaluate the imaging response. For patients achieving objective response, radical hysterectomy (RH, via laparoscopy or laparotomy) and an evaluation of pathologic response are performed. For patients without objective imaging response, the choice of concurrent chemoradiotherapy or radical hysterectomy will be discussed. After RH, adjuvant therapy will be given according to the RH pathologic results.

The primary objectives consist of (1) the objective imaging response after NAC; (2) the objective pathologic response after RH.

The secondary objectives consist of (1) disease-free survival and overall survival after various therapy modalities; (2) severe adverse effects of NAC; (3) the effects of NAC on the surgical outcomes.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 1, 2025
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix

- FIGO stage IB2 to IIB

- Type II or III radical hysterectomy or trachelectomy

- Performance status of Eastern Cooperative Oncology Group (ECOG) 0-1

- Aged 18 years to 45 years

- Well cardiopulmonary, liver and kidney functions for neoadjuvant chemotherapy

- Signed an approved informed consents

Exclusion Criteria:

- Not satisfying any of the inclusion criteria

Study Design


Intervention

Drug:
Two cycles of neoadjuvant chemotherapy
Two cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks).
Diagnostic Test:
First imaging evaluation
First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET)
Second imaging evaluation
Second imaging evaluation consists of pelvic magnetic resonance imaging
Drug:
The third cycles of neoadjuvant chemotherapy
The third cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks).
Procedure:
RH
Radical hysterectomy
Radiation:
Radiochemotherapy
Concurrent radiochemotherapy
Diagnostic Test:
Pathologic evaluation
Pathologic evaluation for RH patients

Locations

Country Name City State
China Lei Li Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective pathologic response Objective pathologic response for patients with radical hysterectomy 3 years
Primary Objective imaging response Objective imaging response for patients with neoadjuvant chemotherapy 3 years
Secondary Disease-free survival Disease-free survival for patients with various therapy modalities 3 years
Secondary Overall survival Overall survival for patients with various therapy modalities 3 years
Secondary Severe adverse events Severe adverse events of neoadjuvant chemotherapy 1 year
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