Neoadjuvant Chemotherapy, Locally Advanced Cervical Cancer, Radical Hysterectomy, Objective Response, Laparoscopy, Laparotomy, Concurrent Chemoradiotherapy, Adjuvant Therapy, Systematic Chemotherapy
Conditions
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.
Interventions
Two cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks).
DIAGNOSTIC_TESTFirst imaging evaluation
First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET)
DIAGNOSTIC_TESTSecond imaging evaluation
Second imaging evaluation consists of pelvic magnetic resonance imaging
DRUGThe 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).
PROCEDURERH
Radical hysterectomy
RADIATIONRadiochemotherapy
Concurrent radiochemotherapy
DIAGNOSTIC_TESTPathologic evaluation
Pathologic evaluation for RH patients
Sponsors
Lei Li
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
patients diagnosed with locally advanced cervical cancer of stage IB2 to IIB (FIGO 2009 system)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective pathologic response | 3 years | Objective pathologic response for patients with radical hysterectomy |
| Objective imaging response | 3 years | Objective imaging response for patients with neoadjuvant chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 3 years | Disease-free survival for patients with various therapy modalities |
| Overall survival | 3 years | Overall survival for patients with various therapy modalities |
| Severe adverse events | 1 year | Severe adverse events of neoadjuvant chemotherapy |
Countries
China
Contacts
Primary ContactLei Li, M.D.
Backup ContactLei Li, M.D.
Outcome results
None listed