Objectives The aim of this trial is to compare response rate and survivals of locally advanced stage cervical cancer patients with residual lesions who had Concurrent Chemoradiation therapy (CCRT) alone to those who had adjuvant chemotherapy after CCRT.
Methods The CQGOG0102 study is a single-center, randomized controlled trial. 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.
Results In our center, a retrospective study found that residual lesion after CCRT was one of the most important prognostic factors in patients with LACC. PFS and OS was decreased when the size of the residual lesion was over 10 mm. A further study showed that patients with residual lesion after CCRT treated with ACT had a significantly longer PFS compared to patients without ACT (22.4m vs. 12m, p <0.05). So, we designed the randomized controlled trial, CQGOG0102, to evaluate the efficacy of ACT in LACC with residual lesions after CCRT. At present, 30 patients have been enrolled. Pathological evidence of cervical residual lesion was identified in 23.3% (7/30). This trial is currently open and enrolling patients.
Conclusions ACT may improve the prognosis of LACC who has the residual lesion after CCRT. We will report the primary, midterm and final results about this study in the future. Clinical trial information: NCT04409860
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