NAC Followed by RH for the Treatment of LACC

NCT03963882 | Unknown Phase 2 DMC

• 1 other identifier: NACC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Objective pathologic response

  Objective pathologic response for patients with radical hysterectomy

  3 years

• Objective imaging response

  Objective imaging response for patients with neoadjuvant chemotherapy

  3 years

Secondary Outcomes (3)

• Disease-free survival

  3 years

• Overall survival

  3 years

• Severe adverse events

  1 year

Study Arms (4)

Group A

EXPERIMENTAL

Patients in group A don't receive neoadjuvant chemotherapy

Diagnostic Test: First imaging evaluation; Radiation: Radiochemotherapy

Group B

EXPERIMENTAL

Patients in group B receive neoadjuvant chemotherapy and achieve imaging response

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; Diagnostic Test: Pathologic evaluation

Group C

EXPERIMENTAL

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

Drug: Two cycles of neoadjuvant chemotherapy; Diagnostic Test: First imaging evaluation; Diagnostic Test: Second imaging evaluation; Radiation: Radiochemotherapy

Group D

EXPERIMENTAL

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

Drug: Two cycles of neoadjuvant chemotherapy; Diagnostic Test: First imaging evaluation; Diagnostic Test: Second imaging evaluation; Procedure: RH; Diagnostic Test: Pathologic evaluation

Interventions

Two cycles of neoadjuvant chemotherapy DRUG

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

Group B; Group C; Group D

First imaging evaluation DIAGNOSTIC_TEST

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

Group A; Group B; Group C; Group D

Second imaging evaluation DIAGNOSTIC_TEST

Second imaging evaluation consists of pelvic magnetic resonance imaging

Group B; Group C; Group D

The third cycles of neoadjuvant chemotherapy DRUG

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

Group B

RH PROCEDURE

Radical hysterectomy

Group B; Group D

Radiochemotherapy RADIATION

Concurrent radiochemotherapy

Group A; Group C

Pathologic evaluation DIAGNOSTIC_TEST

Pathologic evaluation for RH patients

Group B; Group D

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Interventions

Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Lei Li, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

+8613911988831; lileigh@163.com

Lei Li, M.D.

CONTACT

+8613911988831; lilei@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: patients diagnosed with locally advanced cervical cancer of stage IB2 to IIB (FIGO 2009 system)

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: June 19, 2019
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: June 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)