NCT03963882

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Lei Li · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-06-19
• Primary completion: 2024-06-01
• Completion: 2025-06-01
• First posted: 2019-05-28
• Last updated: 2019-06-20

Locations

1 site across 1 country: China