Cervical Cancer, Uterine Cervical Cancer, Uterine Cervical Neoplasms
Conditions
Brief summary
We will conduct a trial to determine whether paclitaxel/cisplatin (TP) as an adjuvant chemotherapy after radical surgery improve disease-free survival (DFS) and overall survival (OS), as well as the quality of life (QoL) among early-stage (FIGO stage IB-IIA) cervical cancer patients with risk factors.
Interventions
DRUGPaclitaxel
135-175 mg/m(2) intravenously (IV) on day 1
DRUGCisplatin
75 mg/m(2) IV on day 2 and 3
RADIATIONPelvic RT
IMRT
Sponsors
Zhejiang University
Shandong University
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 65 Years
Healthy volunteers
No
Inclusion criteria
* FIGO stage: ⅠB～ⅡA, cervical cancer; * Age≤60 years; female, Chinese women; * Initial treatment is radical hysterectomy + pelvic lymph node dissection; * Pathological diagnosis: cervical squamous cell invasive carcinoma; * Pathologic examination and meet the following one of the indications of adjuvant therapy: ① lymph node metastasis, ② parametrial invasion, ③ ≥ 2/3 deep stromal invasion, ④ histopathological grading in poorly differentiated (G2 to G3), ⑤ lymphatic vascular space involvement, ⑥ tumor diameter\> 4cm; * Laboratory tests: WBC≥4×10(9)/L, NEU≥2×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Cr≤ normal * Performance status: Karnofsky score≥60; * No prior treatment; * Receiving extensive resection of uterus (type III) plus pelvic lymph nodes wide resection; pathologically diagnosed with cervical squamous cell carcinoma; * Provide written informed consent.
Exclusion criteria
* With severe or uncontrolled internal disease, unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy * History of organ transplantation, immune diseases; * History of serious mental illness, a history of brain dysfunction; * Drug abuse or a history of drug abuse; * Suffering from other malignancies; * Concurrently participating in other clinical trials * Unable or unwilling to sign informed consents; * Unable or unwilling to abide by protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival (DFS) | up to 3-year | DFS was definite as the time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence. |
Secondary
| Measure | Time frame |
|---|---|
| 3-year overall survivals (OS) | 3-year |
| Quality of Life in two arms | 3 years |
| chemotherapy- and radiotherapy- related adverse effects respectively in two arms | 3 years |
Countries
China
Outcome results
None listed