Clinical trial NCT03963882: NAC Followed by RH for the Treatment of LACC
Official title: Neoadjuvant Chemotherapy Followed by Radical Hysterectomy for the Treatment of Locally Advanced Cervical Cancer: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neoadjuvant Chemotherapy
Locally Advanced Cervical Cancer
Radical Hysterectomy
Objective Response
Laparoscopy
Laparotomy
Concurrent Chemoradiotherapy
Adjuvant Therapy
Systematic Chemotherapy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: patients diagnosed with locally advanced cervical cancer of stage IB2 to IIB (FIGO 2009 system)
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective pathologic response
timeFrame: 3 years
measure: Objective imaging response
timeFrame: 3 years
Secondary outcomes:
measure: Disease-free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
measure: Severe adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: