NAC Followed by RH for the Treatment of LACC

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lei Li, M.D.; Phone Number: +8613911988831; Email: lilei@pumch.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Lei Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Patients in group A don't receive neoadjuvant chemotherapy	Diagnostic test: First imaging evaluation; First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET); Radiation: Radiochemotherapy; Concurrent radiochemotherapy
Experimental: Group B; Patients in group B receive neoadjuvant chemotherapy and achieve imaging response	Diagnostic test: First imaging evaluation; First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET); 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: 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; Diagnostic test: Pathologic evaluation; Pathologic evaluation for RH patients
Experimental: Group C; Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept concurrent chemoradiotherapy	Diagnostic test: First imaging evaluation; First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET); Radiation: Radiochemotherapy; Concurrent radiochemotherapy; 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: Second imaging evaluation; Second imaging evaluation consists of pelvic magnetic resonance imaging
Experimental: Group D; Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept radical hysterectomy	Diagnostic test: First imaging evaluation; First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET); 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: Second imaging evaluation; Second imaging evaluation consists of pelvic magnetic resonance imaging; Procedure: RH; Radical hysterectomy; Diagnostic test: Pathologic evaluation; Pathologic evaluation for RH patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective pathologic response	Objective pathologic response for patients with radical hysterectomy	3 years
Objective imaging response	Objective imaging response for patients with neoadjuvant chemotherapy	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	Disease-free survival for patients with various therapy modalities	3 years
Overall survival	Overall survival for patients with various therapy modalities	3 years
Severe adverse events	Severe adverse events of neoadjuvant chemotherapy	1 year

Collaborators and Investigators

• Sponsor: Lei Li

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2019
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: May 23, 2019
• First Posted (Actual): May 28, 2019

Study Record Updates

• Last Update Posted (Actual): June 20, 2019
• Last Update Submitted That Met QC Criteria: June 19, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: NACC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No