title: A Randomized Controlled Trial Comparing Clinical Outcomes and Toxicity of Lobaplatin- Versus Cisplatin-Based Concurrent Chemotherapy Plus Radiotherapy and High-Dose-Rate Brachytherapy for FIGO Stage II and III Cervical Cancer.
abstract: BACKGROUND
  We designed this randomized controlled trial (RCT) to assess whether lobaplatin-based concurrent chemotherapy might be superior to cisplatin-based concurrent chemotherapy for FIGO stage II and III cervical cancer in terms of efficacy and safety.
  
  
  METHODS
  This prospective, open-label RCT aims to enroll 180 patients with FIGO stage II and III cervical cancer, randomly allocated to one of the three treatment groups (cisplatin 15mg/m2, cisplatin 20mg/m2 and lobaplatin 35mg/m2), with 60 patients in each group. All patients will receive external beam irradiation (EBRT) and high-dose-rate intracavitary brachytherapy (HDR-ICBT). Patients in cisplatin 15mg/m2 and 20mg/m2 groups will be administered four cycles of 15mg/m2 or 20mg/m2 cisplatin intravenously once weekly from the second week to the fifth week during EBRT, while patients inthe lobaplatin 35mg/m2 group will be administered two cycles of 35mg/m2 lobaplatin intravenously in the second and fifth week respectively during pelvic EBRT. All participants will be followed up for at least 12 months. Complete remission rate and progression-free survival (PFS) will be the primary endpoints. Overall survival (OS), incidence of adverse events (AEs), and quality of life will be the secondary endpoints.
  
  
  RESULTS
  Between March 2013 and March 2014, a total of 61 patients with FIGO stage II and III cervical cancer were randomly assigned to cisplatin 15mg/m2 group (n=21), cisplatin 20mg/m2 group (n=21) and lobaplatin 35mg/m2 group (n=19). We conducted a preliminary analysis of the results. Similar rates of complete remission and grades 3-4 gastrointestinal reactions were observed for the three treatment groups (P=0.801 and 0.793, respectively). Grade 3-4 hematologic toxicity was more frequent in the lobaplatin group than the cisplatin group.
  
  
  CONCLUSIONS
  This proposed study will be the first RCT to evaluate whether lobaplatin-based chemoraiotherapy will have beneficial effects, compared with cisplatin-based chemoradiotherapy, on complete remission rate, PFS, OS, AEs and quality of life for FIGO stage II and III cervical cancer.
authors: Department of Radiotherapy Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China E-mail : liuzmail@163.com.
authors: Ji-Quan
authors: JQ
authors: Wang
authors: Tao
authors: T
authors: Wang
authors: Fan
authors: F
authors: Shi
authors: Yun-Yi
authors: YY
authors: Yang
authors: Jin
authors: J
authors: Su
authors: Yan-Lan
authors: YL
authors: Chai
authors: Zi
authors: Z
authors: Liu
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001918:Brachytherapy / Q000009:adverse effects*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000473:pathology / Q000628:therapy; D059248:Chemoradiotherapy / Q000009:adverse effects*; D002945:Cisplatin / Q000008:administration & dosage; D003503:Cyclobutanes / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D005767:Gastrointestinal Diseases / Q000209:etiology* / Q000401:mortality / Q000473:pathology; D006801:Humans; D007970:Leukopenia / Q000209:etiology* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D011379:Prognosis; D011879:Radiotherapy Dosage; D013921:Thrombocytopenia / Q000209:etiology* / Q000401:mortality / Q000473:pathology; D002583:Uterine Cervical Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*
chemical_list: D003503:Cyclobutanes; D009944:Organoplatinum Compounds; C066228:lobaplatin; D002945:Cisplatin