Comparison of outcomes and side effects for neoadjuvant chemotherapy with weekly cisplatin and paclitaxel followed by chemoradiation vs. chemoradiation alone in stage IIB–IVA cervical cancer: study protocol for a randomized controlled trial
Abstract Background Currently, the standard treatment for locally advanced cervical cancer is concurrent chemoradiation (CCRT). The effect of neoadjuvant chemotherapy in advanced cervical cancer is controversial. Studies have shown that the addition of a weekly regimen of neoadjuvant chemotherapy (N...
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2022-01-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-021-05986-z |
| _version_ | 1798026510464974848 |
|---|---|
| author | Jing Li Hua Liu Ya Li Jian Li Lifei Shen Wenqing Long Chenmin Yang Haoping Xu Wenqi Xi Rong Cai Weiwei Feng |
| author_facet | Jing Li Hua Liu Ya Li Jian Li Lifei Shen Wenqing Long Chenmin Yang Haoping Xu Wenqi Xi Rong Cai Weiwei Feng |
| author_sort | Jing Li |
| collection | DOAJ |
| description | Abstract Background Currently, the standard treatment for locally advanced cervical cancer is concurrent chemoradiation (CCRT). The effect of neoadjuvant chemotherapy in advanced cervical cancer is controversial. Studies have shown that the addition of a weekly regimen of neoadjuvant chemotherapy (NACT) followed by CCRT may be superior to a thrice-weekly regimen of NACT and CCRT. Among patients who had not received prior cisplatin, a cisplatin and paclitaxel (TP) regimen resulted in longer overall survival than other regimens. This study aims to investigate the feasibility, safety, and efficacy of NACT with weekly TP followed by CCRT. Methods This is a prospective, randomized, open-labeled, multicentered phase III study. Based on a 65% of 2-year disease-free survival (DFS) rate in the CCRT group and 80% of that in NACT followed by CCRT group, and on prerequisite conditions including an 8% loss to follow-up, a two-sided 5% of type I error probability, and an 80% of power, a total of 300 cases were required for enrollment. Patients with IIB–IVA cervical cancer will be randomly allocated in a 1:1 ratio to one of two intervention arms. In the study arm, patients will receive dose-dense cisplatin (40 mg/m2) and paclitaxel (60 mg/m2) weekly for 4 cycles followed by CCRT (45 Gy in 5 weeks concurrent with cisplatin 40 mg/m2 weekly) plus image-guided adaptive brachytherapy (IGBRT). In the control arm, patients will undergo CCRT treatment. The primary endpoint of the study is 2-year disease-free survival (DFS); the secondary endpoints are 5-year overall survival (OS) and disease-free survival (DFS), the response rate 3 months after treatment completion, grade III/IV adverse effects, and quality of life, and potential biomarkers for predicting treatment response will also be studied. Discussion The data gathered from the study will be used to determine whether NACT with weekly TP followed by CCRT may become an optimized treatment for locally advanced cervical cancer. Trial registration Chinese Clinical Trial Registry ChiCTR1900025327. Registered on 24 August 2019. medresman.org.cn ChiCTR1900025326 |
| first_indexed | 2024-04-11T18:36:35Z |
| format | Article |
| id | doaj.art-9243c139ee6d46a5b0029462e2752c83 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-11T18:36:35Z |
| publishDate | 2022-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-9243c139ee6d46a5b0029462e2752c832022-12-22T04:09:14ZengBMCTrials1745-62152022-01-012311910.1186/s13063-021-05986-zComparison of outcomes and side effects for neoadjuvant chemotherapy with weekly cisplatin and paclitaxel followed by chemoradiation vs. chemoradiation alone in stage IIB–IVA cervical cancer: study protocol for a randomized controlled trialJing Li0Hua Liu1Ya Li2Jian Li3Lifei Shen4Wenqing Long5Chenmin Yang6Haoping Xu7Wenqi Xi8Rong Cai9Weiwei Feng10Department of Gynecology and Obstetrics, Ruijin Hospital, Shanghai Jiaotong University School of MedicineDepartment of Gynecology and Obstetrics, Ruijin Hospital, Shanghai Jiaotong University School of MedicineDepartment of Radiology, Ruijin Hospital, Shanghai Jiaotong University School of MedicineClinical Research Center, Ruijin Hospital, Shanghai Jiaotong University School of MedicineDepartment of Gynecology and Obstetrics, Ruijin Hospital, Shanghai Jiaotong University School of MedicineDepartment of Gynecology and Obstetrics, Ruijin Hospital, Shanghai Jiaotong University School of MedicineDepartment of Gynecology and Obstetrics, Ruijin Hospital, Shanghai Jiaotong University School of MedicineDepartment of Radiotherapy, Ruijin Hospital, Shanghai Jiaotong University School of MedicineDepartment of Oncology, Ruijin Hospital, Shanghai Jiaotong University School of MedicineDepartment of Radiotherapy, Ruijin Hospital, Shanghai Jiaotong University School of MedicineDepartment of Gynecology and Obstetrics, Ruijin Hospital, Shanghai Jiaotong University School of MedicineAbstract Background Currently, the standard treatment for locally advanced cervical cancer is concurrent chemoradiation (CCRT). The effect of neoadjuvant chemotherapy in advanced cervical cancer is controversial. Studies have shown that the addition of a weekly regimen of neoadjuvant chemotherapy (NACT) followed by CCRT may be superior to a thrice-weekly regimen of NACT and CCRT. Among patients who had not received prior cisplatin, a cisplatin and paclitaxel (TP) regimen resulted in longer overall survival than other regimens. This study aims to investigate the feasibility, safety, and efficacy of NACT with weekly TP followed by CCRT. Methods This is a prospective, randomized, open-labeled, multicentered phase III study. Based on a 65% of 2-year disease-free survival (DFS) rate in the CCRT group and 80% of that in NACT followed by CCRT group, and on prerequisite conditions including an 8% loss to follow-up, a two-sided 5% of type I error probability, and an 80% of power, a total of 300 cases were required for enrollment. Patients with IIB–IVA cervical cancer will be randomly allocated in a 1:1 ratio to one of two intervention arms. In the study arm, patients will receive dose-dense cisplatin (40 mg/m2) and paclitaxel (60 mg/m2) weekly for 4 cycles followed by CCRT (45 Gy in 5 weeks concurrent with cisplatin 40 mg/m2 weekly) plus image-guided adaptive brachytherapy (IGBRT). In the control arm, patients will undergo CCRT treatment. The primary endpoint of the study is 2-year disease-free survival (DFS); the secondary endpoints are 5-year overall survival (OS) and disease-free survival (DFS), the response rate 3 months after treatment completion, grade III/IV adverse effects, and quality of life, and potential biomarkers for predicting treatment response will also be studied. Discussion The data gathered from the study will be used to determine whether NACT with weekly TP followed by CCRT may become an optimized treatment for locally advanced cervical cancer. Trial registration Chinese Clinical Trial Registry ChiCTR1900025327. Registered on 24 August 2019. medresman.org.cn ChiCTR1900025326https://doi.org/10.1186/s13063-021-05986-zDose-dense neoadjuvant chemotherapyWeekly cisplatin/paclitaxelConcurrent chemoradiotherapy (CCRT)Stage IIB–IVA cervical cancer |
| spellingShingle | Jing Li Hua Liu Ya Li Jian Li Lifei Shen Wenqing Long Chenmin Yang Haoping Xu Wenqi Xi Rong Cai Weiwei Feng Comparison of outcomes and side effects for neoadjuvant chemotherapy with weekly cisplatin and paclitaxel followed by chemoradiation vs. chemoradiation alone in stage IIB–IVA cervical cancer: study protocol for a randomized controlled trial Trials Dose-dense neoadjuvant chemotherapy Weekly cisplatin/paclitaxel Concurrent chemoradiotherapy (CCRT) Stage IIB–IVA cervical cancer |
| title | Comparison of outcomes and side effects for neoadjuvant chemotherapy with weekly cisplatin and paclitaxel followed by chemoradiation vs. chemoradiation alone in stage IIB–IVA cervical cancer: study protocol for a randomized controlled trial |
| title_full | Comparison of outcomes and side effects for neoadjuvant chemotherapy with weekly cisplatin and paclitaxel followed by chemoradiation vs. chemoradiation alone in stage IIB–IVA cervical cancer: study protocol for a randomized controlled trial |
| title_fullStr | Comparison of outcomes and side effects for neoadjuvant chemotherapy with weekly cisplatin and paclitaxel followed by chemoradiation vs. chemoradiation alone in stage IIB–IVA cervical cancer: study protocol for a randomized controlled trial |
| title_full_unstemmed | Comparison of outcomes and side effects for neoadjuvant chemotherapy with weekly cisplatin and paclitaxel followed by chemoradiation vs. chemoradiation alone in stage IIB–IVA cervical cancer: study protocol for a randomized controlled trial |
| title_short | Comparison of outcomes and side effects for neoadjuvant chemotherapy with weekly cisplatin and paclitaxel followed by chemoradiation vs. chemoradiation alone in stage IIB–IVA cervical cancer: study protocol for a randomized controlled trial |
| title_sort | comparison of outcomes and side effects for neoadjuvant chemotherapy with weekly cisplatin and paclitaxel followed by chemoradiation vs chemoradiation alone in stage iib iva cervical cancer study protocol for a randomized controlled trial |
| topic | Dose-dense neoadjuvant chemotherapy Weekly cisplatin/paclitaxel Concurrent chemoradiotherapy (CCRT) Stage IIB–IVA cervical cancer |
| url | https://doi.org/10.1186/s13063-021-05986-z |
| work_keys_str_mv | AT jingli comparisonofoutcomesandsideeffectsforneoadjuvantchemotherapywithweeklycisplatinandpaclitaxelfollowedbychemoradiationvschemoradiationaloneinstageiibivacervicalcancerstudyprotocolforarandomizedcontrolledtrial AT hualiu comparisonofoutcomesandsideeffectsforneoadjuvantchemotherapywithweeklycisplatinandpaclitaxelfollowedbychemoradiationvschemoradiationaloneinstageiibivacervicalcancerstudyprotocolforarandomizedcontrolledtrial AT yali comparisonofoutcomesandsideeffectsforneoadjuvantchemotherapywithweeklycisplatinandpaclitaxelfollowedbychemoradiationvschemoradiationaloneinstageiibivacervicalcancerstudyprotocolforarandomizedcontrolledtrial AT jianli comparisonofoutcomesandsideeffectsforneoadjuvantchemotherapywithweeklycisplatinandpaclitaxelfollowedbychemoradiationvschemoradiationaloneinstageiibivacervicalcancerstudyprotocolforarandomizedcontrolledtrial AT lifeishen comparisonofoutcomesandsideeffectsforneoadjuvantchemotherapywithweeklycisplatinandpaclitaxelfollowedbychemoradiationvschemoradiationaloneinstageiibivacervicalcancerstudyprotocolforarandomizedcontrolledtrial AT wenqinglong comparisonofoutcomesandsideeffectsforneoadjuvantchemotherapywithweeklycisplatinandpaclitaxelfollowedbychemoradiationvschemoradiationaloneinstageiibivacervicalcancerstudyprotocolforarandomizedcontrolledtrial AT chenminyang comparisonofoutcomesandsideeffectsforneoadjuvantchemotherapywithweeklycisplatinandpaclitaxelfollowedbychemoradiationvschemoradiationaloneinstageiibivacervicalcancerstudyprotocolforarandomizedcontrolledtrial AT haopingxu comparisonofoutcomesandsideeffectsforneoadjuvantchemotherapywithweeklycisplatinandpaclitaxelfollowedbychemoradiationvschemoradiationaloneinstageiibivacervicalcancerstudyprotocolforarandomizedcontrolledtrial AT wenqixi comparisonofoutcomesandsideeffectsforneoadjuvantchemotherapywithweeklycisplatinandpaclitaxelfollowedbychemoradiationvschemoradiationaloneinstageiibivacervicalcancerstudyprotocolforarandomizedcontrolledtrial AT rongcai comparisonofoutcomesandsideeffectsforneoadjuvantchemotherapywithweeklycisplatinandpaclitaxelfollowedbychemoradiationvschemoradiationaloneinstageiibivacervicalcancerstudyprotocolforarandomizedcontrolledtrial AT weiweifeng comparisonofoutcomesandsideeffectsforneoadjuvantchemotherapywithweeklycisplatinandpaclitaxelfollowedbychemoradiationvschemoradiationaloneinstageiibivacervicalcancerstudyprotocolforarandomizedcontrolledtrial |