NAC Followed by RH for the Treatment of LACC

• Sponsor: Lei Li (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03963882
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 71.4
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neoadjuvant Chemotherapy; Locally Advanced Cervical Cancer; Radical Hysterectomy; Objective Response; Laparoscopy; Laparotomy; Concurrent Chemoradiotherapy; Adjuvant Therapy; Systematic Chemotherapy	Drug: Two cycles of neoadjuvant chemotherapy; Diagnostic Test: First imaging evaluation; Diagnostic Test: Second imaging evaluation; Drug: The third cycles of neoadjuvant chemotherapy; Procedure: RH; Radiation: Radiochemotherapy; Diagnostic Test: Pathologic evaluation	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: patients diagnosed with locally advanced cervical cancer of stage IB2 to IIB (FIGO 2009 system)patients diagnosed with locally advanced cervical cancer of stage IB2 to IIB (FIGO 2009 system)
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Neoadjuvant Chemotherapy Followed by Radical Hysterectomy for the Treatment of Locally Advanced Cervical Cancer: A Prospective Cohort Study
• Actual Study Start Date: Jun 19, 2019
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

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	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; 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	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; Radiation: Radiochemotherapy; Concurrent radiochemotherapy
Experimental: Group D Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept radical hysterectomy	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; Procedure: RH; Radical hysterectomy; Diagnostic Test: Pathologic evaluation; Pathologic evaluation for RH patients

Outcome Measures

Primary Outcome Measures

1. Objective pathologic response [3 years]

   Objective pathologic response for patients with radical hysterectomy

2. Objective imaging response [3 years]

   Objective imaging response for patients with neoadjuvant chemotherapy

Secondary Outcome Measures

1. Disease-free survival [3 years]

   Disease-free survival for patients with various therapy modalities

2. Overall survival [3 years]

   Overall survival for patients with various therapy modalities

3. Severe adverse events [1 year]

   Severe adverse events of neoadjuvant chemotherapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lei Li	Beijing	Beijing	China	100730

Sponsors and Collaborators

• Lei Li

Investigators

• Principal Investigator: Lei Li, M.D., Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT03963882
• Other Study ID Numbers: NACC
• First Posted: May 28, 2019
• Last Update Posted: Jun 20, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Uterine Cervical Neoplasms

Study Results

No Results Posted as of Jun 20, 2019