Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2019-06-19
2025-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Group A
Patients in group A don't receive neoadjuvant chemotherapy
First imaging evaluation
First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET)
Radiochemotherapy
Concurrent radiochemotherapy
Group B
Patients in group B receive neoadjuvant chemotherapy and achieve imaging response
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).
First imaging evaluation
First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET)
Second imaging evaluation
Second imaging evaluation consists of pelvic magnetic resonance imaging
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).
RH
Radical hysterectomy
Pathologic evaluation
Pathologic evaluation for RH patients
Group C
Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept concurrent chemoradiotherapy
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).
First imaging evaluation
First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET)
Second imaging evaluation
Second imaging evaluation consists of pelvic magnetic resonance imaging
Radiochemotherapy
Concurrent radiochemotherapy
Group D
Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept radical hysterectomy
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).
First imaging evaluation
First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET)
Second imaging evaluation
Second imaging evaluation consists of pelvic magnetic resonance imaging
RH
Radical hysterectomy
Pathologic evaluation
Pathologic evaluation for RH patients
Interventions
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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).
First imaging evaluation
First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET)
Second imaging evaluation
Second imaging evaluation consists of pelvic magnetic resonance imaging
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).
RH
Radical hysterectomy
Radiochemotherapy
Concurrent radiochemotherapy
Pathologic evaluation
Pathologic evaluation for RH patients
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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Lei Li
OTHER
Responsible Party
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Lei Li
Professor
Principal Investigators
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Lei Li, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Lei Li
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NACC
Identifier Type: -
Identifier Source: org_study_id
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