The aim of this trial was to evaluate the efficacy of adjuvant chemotherapy in the locally advanced cervical cancer with residual lesions after concurrent chemoradiation therapy.
1. Objective: To compare response rate and survivals of locally advanced stage cervical cancer patients with residual lesions who had CCRT alone to those who had adjuvant chemotherapy after CCRT. 2. Patients: 1. Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma 2. Complete CCRT(Radiation Does: A point 85Gy(+/-10%), B点50Gy(+/-10%), concurrent platinum-containing chemotherapy(cisplatin or carboplatin) 3. MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm). 3. Methods: The patients who have residual lesions after CCRT are randomized to arm A by observation or arm B by adjuvant chemotherapy with paclitaxel plus cisplatin every 3 weeks for 3 cycles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)
The regimen of adjuvant chemotherapy following CCRT is Paclitaxel(150mg/m2 D1), Cisplatin(60mg/m2 D1) , q3w, three cycles.
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGPFS
Progression-free survival
Time frame: 2 years
OS
5 years overall survival
Time frame: 5 years
ORR
To evaluate the objective response rate(CR+PR) of adjuvant chemotherapy in cervical cancer
Time frame: 3 months
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