A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
This trial is active, not recruiting.
|Conditions||uterine cervical neoplasms, cervical cancer, uterine cervical cancer|
|Treatments||radical hysterectomy + pelvic lymph node dissection, paclitaxel, cisplatin, pelvic rt|
|Sponsor||Huazhong University of Science and Technology|
|Start date||November 2012|
|End date||December 2015|
|Trial size||300 participants|
|Trial identifier||NCT01755897, 2012-GYN/CC-01|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Wuhan, China||Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology||no longer recruiting|
|Jinan, China||Qilu Hospital, Shandong University||no longer recruiting|
|Hangzhou, China||Women's Hospital, School of Medicine, Zhejiang University||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
disease-free survival (DFS) of the adjuvant chemotherapy arm (arm A)
time frame: up to 3-year
DFS of the adjuvant CCRT arm (arm B)
time frame: 1-year DFS and 3-year DFS
3-year overall survivals (OS) of the arm A and the arm B
time frame: 3-year
Quality of Life in two arms
time frame: 3 years
chemotherapy- and radiotherapy- related adverse effects respectively in two arms
time frame: 3 years
Female participants up to 60 years old.
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.
|Official title||A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients|
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