A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
Not Applicable
Completed
- Conditions
- Uterine Cervical CancerUterine Cervical NeoplasmsCervical Cancer
- Interventions
- Procedure: radical hysterectomy + pelvic lymph node dissectionRadiation: Pelvic RT
- Registration Number
- NCT01755897
- Lead Sponsor
- Huazhong University of Science and Technology
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 337
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adjuvant Chemotherapy (Arm A) radical hysterectomy + pelvic lymph node dissection Paclitaxel (T): 135-175 mg/m(2) intravenously (IV) on day 1, administrated intravenously over 3 hours; followed by cisplatin 75-85 mg/m(2) IV on day 2 and 3. Patients received at least 3 cycles at 4-week intervals beginning 2-3 weeks after surgery. 3-6 cycles as necessary. Concurrent radiochemotherapy, CCRT (Arm B) radical hysterectomy + pelvic lymph node dissection Pelvic RT is delivered using IMRT technique, 45～50.4 Gy/4～7 weeks, brachytherapy will been given as necessary. Cisplatin 35 mg/m(2) IV once a week. Total treatment time is 6-7 weeks. Concurrent radiochemotherapy, CCRT (Arm B) Pelvic RT Pelvic RT is delivered using IMRT technique, 45～50.4 Gy/4～7 weeks, brachytherapy will been given as necessary. Cisplatin 35 mg/m(2) IV once a week. Total treatment time is 6-7 weeks. Adjuvant Chemotherapy (Arm A) Paclitaxel Paclitaxel (T): 135-175 mg/m(2) intravenously (IV) on day 1, administrated intravenously over 3 hours; followed by cisplatin 75-85 mg/m(2) IV on day 2 and 3. Patients received at least 3 cycles at 4-week intervals beginning 2-3 weeks after surgery. 3-6 cycles as necessary. Adjuvant Chemotherapy (Arm A) Cisplatin Paclitaxel (T): 135-175 mg/m(2) intravenously (IV) on day 1, administrated intravenously over 3 hours; followed by cisplatin 75-85 mg/m(2) IV on day 2 and 3. Patients received at least 3 cycles at 4-week intervals beginning 2-3 weeks after surgery. 3-6 cycles as necessary. Concurrent radiochemotherapy, CCRT (Arm B) Cisplatin Pelvic RT is delivered using IMRT technique, 45～50.4 Gy/4～7 weeks, brachytherapy will been given as necessary. Cisplatin 35 mg/m(2) IV once a week. Total treatment time is 6-7 weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Quality of Life in two arms 3 years 3-year overall survivals (OS) 3-year chemotherapy- and radiotherapy- related adverse effects respectively in two arms 3 years
Trial Locations
- Locations (3)
Qilu Hospital, Shandong University
🇨🇳Jinan, Shandong, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Women's Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China