NAC Followed by RH for the Treatment of LACC

Lei Li60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoadjuvant Chemotherapy Locally Advanced Cervical Cancer

Interventions

Two cycles of neoadjuvant chemotherapyDRUG

Two cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks).

First imaging evaluationDIAGNOSTIC_TEST

First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET)

Second imaging evaluationDIAGNOSTIC_TEST

Second imaging evaluation consists of pelvic magnetic resonance imaging

The third cycles of neoadjuvant chemotherapyDRUG

The third cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks).

RHPROCEDURE

Radical hysterectomy

RadiochemotherapyRADIATION

Concurrent radiochemotherapy

Pathologic evaluationDIAGNOSTIC_TEST

Pathologic evaluation for RH patients

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Objective pathologic response

Objective pathologic response for patients with radical hysterectomy

Time frame: 3 years

Objective imaging response

Objective imaging response for patients with neoadjuvant chemotherapy

Time frame: 3 years

Secondary Outcomes

Disease-free survival

Disease-free survival for patients with various therapy modalities

Time frame: 3 years

Overall survival

Overall survival for patients with various therapy modalities

Time frame: 3 years

Severe adverse events

Severe adverse events of neoadjuvant chemotherapy

Time frame: 1 year

NAC Followed by RH for the Treatment of LACC

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts