NAC Followed by RH for the Treatment of LACC

Laparoscopy Clinical Trial

Official title:

Neoadjuvant Chemotherapy Followed by Radical Hysterectomy for the Treatment of Locally Advanced Cervical Cancer: A Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03963882
• Other study ID #: NACC
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Adjuvant Therapy
• Concurrent Chemoradiotherapy
• Laparoscopy
• Laparotomy
• Locally Advanced Cervical Cancer
• Neoadjuvant Chemotherapy
• Objective Response
• Radical Hysterectomy
• Systematic Chemotherapy
• Uterine Cervical Neoplasms

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