NAC Followed by RH for the Treatment of LACC

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.

Conditions

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

Interventions

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)

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

RADIATION

Radiochemotherapy

Concurrent radiochemotherapy

DIAGNOSTIC_TEST

Pathologic evaluation

Pathologic evaluation for RH patients

Sponsors & Collaborators

• Lei Li

  lead OTHER

Principal Investigators

• Lei Li, M.D. · Peking Union Medical College Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-19

Primary Completion

2024-06-01

Completion

2025-06-01

Countries

• China

Study Locations