drugset / Trial / NCT02288195
CONVERT: Neoadjuvant Chemotherapy Alone Versus Preoperative Chemoradiation for Locally Advanced Rectal Cancer Patients
Phase 3
Unknown
663 enrolled
Sun Yat-sen University
Affiliated Cancer Hospital of Shantou University Medical College · collabCancer Hospital of Guangxi Medical University · collabFirst Affiliated Hospital of Chongqing Medical University · collabFirst Affiliated Hospital of Kunming Medical University · collabFujian Cancer Hospital · collabGuangdong Provincial Hospital of Traditional Chinese Medicine · collabGuangdong Provincial People's Hospital · collabHenan Cancer Hospital · collabHubei Cancer Hospital · collabJiangmen Central Hospital · collabLiaoning Cancer Hospital & Institute · collabLongyan City First Hospital · collabMeizhou People's Hospital · collabShantou Central Hospital · collabShengjing Hospital · collabThe First Affiliated Hospital of Guangzhou Medical University · collabThe First Affiliated Hospital with Nanjing Medical University · collabThe Third Affiliated Hospital of Kunming Medical College. · collabWest China Hospital · collabZhejiang Cancer Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Although neoadjuvant radiotherapy greatly decreases local recurrence in locally advanced rectal cancer patients undergoing surgery, it inevitably results in short-term and long-term toxicities. More importantly, it has not been confirmed that neoadjuvant radiotherapy could improve overall survival. The purpose of this study is to compare the effects of chemotherapy alone using a combination regimen known as XELOX (capecitabine and oxaliplatin ) and selective use of the standard treatment to the standard treatment of chemotherapy and radiation.
Timeline
- Start
- 2014-08-13
- Primary completion
- 2021-03-17
- Completion
- 2024-03
Outcome
Missed primary endpoint
paper The non-inferiority of nCT was not confirmed with a very low incidence of local recurrence in both group. PMID 41712876 ↗
Publications
- Results Mei WJ, Wang XZ, Li YF, Sun YM, Yang CK, Lin JZ, Wu ZG, Zhang R, Wang W, Li Y, Zhuang YZ, Lei J, Wan XB, Ren YK, Cheng Y, Li WL, Wang ZQ, Xu DB, Mo XW, Ju HX, Ye SW, Zhao JL, Zhang H, Gao YH, Zeng ZF, Xiao WW, Zhang XP, Zhang X, Xie E, Feng YF, Tang JH, Wu XJ, Chen G, Li LR, Lu ZH, Wan DS, Bei JX, Pan ZZ, Ding PR. Neoadjuvant Chemotherapy With CAPOX Versus Chemoradiation for Locally Advanced Rectal Cancer With Uninvolved Mesorectal Fascia (CONVERT): Initial Results of a Phase III Trial. Ann Surg. 2023 Apr 1;277(4):557-564. doi: 10.1097/SLA.0000000000005780. Epub 2022 Dec 20.
- Mei WJ, Wang XZ, Zhang X, Sun YM, Yang CK, Lin JZ, Wu ZG, Zhang R, Wang W, Li Y, Zhuang YZ, Lei J, Wan XB, Ren YK, Cheng Y, Li WL, Wang ZQ, Xu DB, Mo XW, Ju HX, Ye SW, Zhao JL, Zhang H, Gao YH, Zeng ZF, Xiao WW, Zhang XP, Li YF, Xie E, Feng YF, Tang JH, Wu XJ, Chen G, Li LR, Lu ZH, Wan DS, Bei JX, Pan ZZ, Yu JH, Ding PR. Neoadjuvant Chemotherapy With CAPOX Versus Chemoradiation for Locally Advanced Rectal Cancer With Uninvolved Mesorectal Fascia (CONVERT): Final Results of a Phase III Trial. J Clin Oncol. 2026 Apr 10;44(11):970-980. doi: 10.1200/JCO-25-00731. Epub 2026 Feb 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 825 mg/m2 | Oral |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |