NAC Followed by RH for the Treatment of LACC

Lei Li

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: The third cycles of neoadjuvant chemotherapy; Diagnostic Test: Second imaging evaluation; Procedure: RH; Diagnostic Test: First imaging evaluation; Drug: Two cycles of neoadjuvant chemotherapy; Diagnostic Test: Pathologic evaluation; Radiation: Radiochemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03963882

NACC

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Group A

Experimental group

Description:

Patients in group A don't receive neoadjuvant chemotherapy

Treatment:

Radiation: Radiochemotherapy

Diagnostic Test: First imaging evaluation

Group B

Experimental group

Description:

Patients in group B receive neoadjuvant chemotherapy and achieve imaging response

Treatment:

Drug: Two cycles of neoadjuvant chemotherapy

Drug: The third cycles of neoadjuvant chemotherapy

Procedure: RH

Diagnostic Test: Pathologic evaluation

Diagnostic Test: Second imaging evaluation

Diagnostic Test: First imaging evaluation

Group C

Experimental group

Description:

Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept concurrent chemoradiotherapy

Treatment:

Drug: Two cycles of neoadjuvant chemotherapy

Radiation: Radiochemotherapy

Diagnostic Test: Second imaging evaluation

Diagnostic Test: First imaging evaluation

Group D

Experimental group

Description:

Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept radical hysterectomy

Treatment:

Drug: Two cycles of neoadjuvant chemotherapy

Procedure: RH

Diagnostic Test: Pathologic evaluation

Diagnostic Test: Second imaging evaluation

Diagnostic Test: First imaging evaluation