Laparoscopy Clinical Trial
Official title:
Neoadjuvant Chemotherapy Followed by Radical Hysterectomy for the Treatment of Locally Advanced Cervical Cancer: A Prospective Cohort Study
NCT number | NCT03963882 |
Other study ID # | NACC |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 19, 2019 |
Est. completion date | June 1, 2025 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 1, 2025 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Lei Li | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Lei Li |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective pathologic response | Objective pathologic response for patients with radical hysterectomy | 3 years | |
Primary | Objective imaging response | Objective imaging response for patients with neoadjuvant chemotherapy | 3 years | |
Secondary | Disease-free survival | Disease-free survival for patients with various therapy modalities | 3 years | |
Secondary | Overall survival | Overall survival for patients with various therapy modalities | 3 years | |
Secondary | Severe adverse events | Severe adverse events of neoadjuvant chemotherapy | 1 year |
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