NAC Followed by RH for the Treatment of LACC

Phase 2

Recruiting

• Conditions: Neoadjuvant Chemotherapy; Laparoscopy; Locally Advanced Cervical Cancer; Concurrent Chemoradiotherapy; Radical Hysterectomy; Adjuvant Therapy; Systematic Chemotherapy; Objective Response; Laparotomy
• Interventions: Diagnostic Test: First imaging evaluation; Drug: Two cycles of neoadjuvant chemotherapy; Radiation: Radiochemotherapy; Diagnostic Test: Second imaging evaluation; Drug: The third cycles of neoadjuvant chemotherapy; Procedure: RH; Diagnostic Test: Pathologic evaluation

• Registration Number: NCT03963882
• Lead Sponsor: Lei Li

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-05-23
• Study First Posted: 2019-05-28
• Status Verified: 2019-06
• Study Start: 2019-06-19
• Last Update Submitted: 2019-06-19
• Last Update Posted: 2019-06-20
• Primary Completion: 2024-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A	First imaging evaluation	Patients in group A don't receive neoadjuvant chemotherapy
Group A	Radiochemotherapy	Patients in group A don't receive neoadjuvant chemotherapy
Group B	Two cycles of neoadjuvant chemotherapy	Patients in group B receive neoadjuvant chemotherapy and achieve imaging response
Group B	First imaging evaluation	Patients in group B receive neoadjuvant chemotherapy and achieve imaging response
Group B	Second imaging evaluation	Patients in group B receive neoadjuvant chemotherapy and achieve imaging response
Group B	The third cycles of neoadjuvant chemotherapy	Patients in group B receive neoadjuvant chemotherapy and achieve imaging response
Group B	RH	Patients in group B receive neoadjuvant chemotherapy and achieve imaging response
Group B	Pathologic evaluation	Patients in group B receive neoadjuvant chemotherapy and achieve imaging response
Group C	Two cycles of neoadjuvant chemotherapy	Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept concurrent chemoradiotherapy
Group C	First imaging evaluation	Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept concurrent chemoradiotherapy
Group C	Second imaging evaluation	Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept concurrent chemoradiotherapy
Group C	Radiochemotherapy	Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept concurrent chemoradiotherapy
Group D	Two cycles of neoadjuvant chemotherapy	Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept radical hysterectomy
Group D	First imaging evaluation	Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept radical hysterectomy
Group D	RH	Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept radical hysterectomy
Group D	Second imaging evaluation	Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept radical hysterectomy
Group D	Pathologic evaluation	Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept radical hysterectomy

Primary Outcome Measures

Name	Time	Method
Objective pathologic response	3 years	Objective pathologic response for patients with radical hysterectomy
Objective imaging response	3 years	Objective imaging response for patients with neoadjuvant chemotherapy

Secondary Outcome Measures

Name	Time	Method
Severe adverse events	1 year	Severe adverse events of neoadjuvant chemotherapy
Overall survival	3 years	Overall survival for patients with various therapy modalities
Disease-free survival	3 years	Disease-free survival for patients with various therapy modalities

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China