title: Prospective randomized study comparing concomitant chemoradiotherapy using weekly cisplatin & paclitaxel versus weekly cisplatin in locally advanced carcinoma cervix.
abstract: BACKGROUND
  To evaluate the benefit with the addition of paclitaxel to cisplatin-based concurrent chemoradiotherapy (C-CRT) for the treatment of locally advanced carcinoma of the uterine cervix in terms of local control, disease free survival (DFS) and overall survival (OS).
  
  
  METHODS
  From 1/7/2011 to 31/5/2012, 81 women (median age of 50 years) with newly diagnosed, histopathologically proven carcinoma cervix with FIGO stages IIA to IIIB were randomized to two arms-cisplatin 40 mg/m(2)/week for 5 weeks was given in single agent cisplatin (control arm), while cisplatin 30 mg/m(2)/week and paclitaxel 50 mg/m(2)/week for 5 weeks were given in cisplatin and paclitaxel (study arm). External beam radiotherapy (EBRT) was delivered to a total dose of 50 Gray (Gy) in 25 fractions (#) followed by intracavitary (I/C) brachytherapy or supplement EBRT at 20 Gy/10# with 2 cycles of respective chemotherapy. This prospective trial was registered with clinicaltrials.gov (NCT01593306).
  
  
  RESULTS
  Patients (n=81) had a maximum follow up of 36 months with a median follow up of 29 months. At first follow up study arm showed complete response in 84% vs. 75.6% in control arm (P=0.4095). An increase in toxicities was observed in the study arm in comparison to the control arm in terms of haematological grade II (35% vs. 12.2%), gastrointestinal (GI) grade III (20% vs. 7.4%) and GI grade IV (12.5% vs. 2.4%) toxicities. At median follow-up, the study arm demonstrated enhanced outcomes over the control arm in terms of DFS (79.5% vs. 64.3%; P=0.07) and OS (87.2% vs. 78.6%; P=0.27).
  
  
  CONCLUSIONS
  Despite the expected increase in manageable toxicities, these early results reveal promise with the inclusion of paclitaxel into the standard cisplatin based chemoradiation regime. Larger multi-institutional studies are justified to confirm a potential for the enhancement of response rates and survival.
authors.affiliation: 1 Department of Radiation Oncology, Regional Cancer Centre, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India ; 2 Department of Radiation Oncology, Regional Cancer Centre, Post graduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Pragyat
authors.initials: P
authors.lastname: Thakur
authors.affiliation: 1 Department of Radiation Oncology, Regional Cancer Centre, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India ; 2 Department of Radiation Oncology, Regional Cancer Centre, Post graduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Rajeev
authors.initials: R
authors.lastname: Seam
authors.affiliation: 1 Department of Radiation Oncology, Regional Cancer Centre, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India ; 2 Department of Radiation Oncology, Regional Cancer Centre, Post graduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Manoj
authors.initials: M
authors.lastname: Gupta
authors.affiliation: 1 Department of Radiation Oncology, Regional Cancer Centre, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India ; 2 Department of Radiation Oncology, Regional Cancer Centre, Post graduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Manish
authors.initials: M
authors.lastname: Gupta
keywords: Intracavitary brachytherapy; disease free survival (DFS); external beam radiotherapy (EBRT); overall survival (OS); toxicity