title: Low-dose fractionated radiation and chemotherapy prior to definitive chemoradiation in locally advanced carcinoma of the uterine cervix: Results of a prospective phase II clinical trial.
abstract: BACKGROUND
  We investigated the feasibility of neoadjuvant low-dose radiation and chemotherapy with paclitaxel and carboplatin (LDCRT) before radical chemoradiation (CRT) and assessed the feasibility, efficacy, and response rate to such a regimen.
  
  
  METHODS
  This is a single-arm phase II trial of 24 patients, with locally advanced squamous cell carcinoma of the cervix (stage IIB-IIIB). Patients received low-dose fractionated radiotherapy, carboplatin (AUC×5) and paclitaxel (175 mg/m(2)), three weekly for two cycles followed by CRT. The primary end point was overall and disease-free survival.
  
  
  RESULTS
  Mean age of the patients at diagnosis was 50 years; Radiological complete or partial response rate was 40% and 60%, respectively, post-LDCRT. The median follow-up was 30 months (24-36 months). Both overall and progression-free survivals at 2.5 years were 84%. Grade 3/4 toxicities were 24% hematological toxicity during LDCRT and 46% during CRT (hematological: 42%, non-hematological: 4%).
  
  
  CONCLUSIONS
  A good response rate is achieved by low-dose radiation and chemotherapy with carboplatin and paclitaxel followed by radical CRT. This treatment regimen is feasible and effective as evidenced by the acceptable toxicity and 84% local control at 2.5 years.
authors.affiliation: Department of Radiation Oncology, Christian Medical College Vellore, India. Electronic address: saikat@cmcvellore.ac.in.
authors.forename: Saikat
authors.initials: S
authors.lastname: Das
authors.affiliation: Department of Radiation Oncology, Christian Medical College Vellore, India.
authors.forename: J
authors.initials: J
authors.lastname: Subhashini
authors.affiliation: Department of Radiation Oncology, Christian Medical College Vellore, India.
authors.forename: Jeba Karunya
authors.initials: JK
authors.lastname: Rami Reddy
authors.affiliation: Department of Radiation Oncology, Christian Medical College Vellore, India.
authors.forename: Suparna
authors.initials: S
authors.lastname: KantiPal
authors.affiliation: Department of Radiation Oncology, Christian Medical College Vellore, India.
authors.forename: Rajesh
authors.initials: R
authors.lastname: Isiah
authors.affiliation: Department of Nuclear Medicine, Christian Medical College Vellore, India.
authors.forename: Regi
authors.initials: R
authors.lastname: Oommen
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D059248:Chemoradiotherapy; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D004307:Dose-Response Relationship, Radiation; D005260:Female; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D011446:Prospective Studies; D015996:Survival Rate; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*
chemical_list: D016190:Carboplatin; D017239:Paclitaxel
keywords: Chemo-radiotherapy; Induced radioresistance; Low-dose radiation; Neoadjuvant therapy; Uterine cervical neoplasm