A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients

Conditions
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Uterine Cervical Neoplasms, Cervical Cancer, Uterine Cervical Cancer

Intervention / Treatment
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* Procedure: radical hysterectomy + pelvic lymph node dissection
* Drug: Paclitaxel
* Drug: Cisplatin
* Drug: Cisplatin
* Radiation: Pelvic RT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adjuvant Chemotherapy (Arm A)<br>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. | Procedure: radical hysterectomy + pelvic lymph node dissection<br> <br> Drug: Paclitaxel<br>* 135-175 mg/m(2) intravenously (IV) on day 1<br>Drug: Cisplatin<br>* 75 mg/m(2) IV on day 2 and 3<br>|
| Active Comparator: Concurrent radiochemotherapy, CCRT (Arm B)<br>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. | Procedure: radical hysterectomy + pelvic lymph node dissection<br> <br> Drug: Cisplatin<br>* 35 mg/m(2) IV once a week<br>Radiation: Pelvic RT<br>* IMRT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival (DFS) | 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. | up to 3-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |