Overview

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
Phase phase 3
Sponsor Huazhong University of Science and Technology
Collaborator Zhejiang University
Start date November 2012
End date December 2015
Trial size 300 participants
Trial identifier NCT01755897, 2012-GYN/CC-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
radical hysterectomy + pelvic lymph node dissection
paclitaxel
135-175 mg/m(2) intravenously (IV) on day 1
cisplatin
75 mg/m(2) IV on day 2 and 3
(Active Comparator)
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.
radical hysterectomy + pelvic lymph node dissection
cisplatin
35 mg/m(2) IV once a week
pelvic rt
IMRT

Primary Outcomes

Measure
disease-free survival (DFS) of the adjuvant chemotherapy arm (arm A)
time frame: up to 3-year

Secondary Outcomes

Measure
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

Eligibility Criteria

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.

Additional Information

Official title A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Huazhong University of Science and Technology.