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24 UTERUS-11 STUDY: A randomized clinical trial on surgical staging versus ct-staging prior to primary chemoradiation in patients with FIGO2009 stages IIB-IVA cervical cancer
  1. S Marnitz-Schulze1,
  2. A Tsunoda2,
  3. P Martus3,
  4. MV Vieira4,
  5. R Affonso5,
  6. JS Nunes6,
  7. V Budach7,
  8. A Schneider8,
  9. H Hertel9,
  10. A Mustea10,
  11. J Sehouli11,
  12. A Plaikner12,
  13. A Ebert13 and
  14. C Köhler14
  1. 1Uniklinik Köln, Klinik und Poliklinik für Strahlentherapie, Köln, Germany
  2. 2Hospital Erasto Gaertner, Gynecologic Oncology, Curitiba, Brazil
  3. 3Tübingen University, Institute for Clinical Epidemiology and Applied Biometry, tübingen, Germany
  4. 4Hospital de Amor Barretos, Gynecologic Oncology, Barretos, Brazil
  5. 5Hospital de Amor Barretos, Radiation Oncology, Barretos, Brazil
  6. 6Hospital Erasto Gaertner, Medical Oncology, Curitiba, Brazil
  7. 7Charité – Universitätsmedizin Berlin, Radiation Oncology, Berlin, Germany
  8. 8Fürstenberg-Karree Berlin, Gynecologic Oncology, Berlin, Germany
  9. 9Hannover Medical School, Oncology, Hannover, Germany
  10. 10Greifswald Medical University, Gynecologic Oncology, Greifswald, Germany
  11. 11Charité – Universitätsmedizin Berlin, Gynecologic Oncology, Berlin, Germany
  12. 12Asklepios Klinik Altona, Gynecologic Oncology, Hamburg, Germany
  13. 13Practice for Women’s Health, Gynecology and Obstetrics, Berlin, Germany
  14. 14Asklepios Kliniken, Gynecologic Oncology, Hamburg, Germany


Objectives Surgical staging potentially modifies radiation field in locally advanced cervical cancer (LACC), although a survival benefit has never been proved in a randomized clinical trial.

Uterus-11 Study (German GOG and Radiation Oncology Group) is a RCT designed to evaluate the impact of surgical staging compared to standard clinical/radiological staging, followed by chemoradiation (CR). Primary endpoint was disease free survival (DFS), secondary was overall survival (OS).

Methods From 2009 to 2013, a total of 255 LACC patients (FIGO2009 IIB-IVA) were randomized to surgical staging and CR (ArmA), or clinical staging followed by CR (ArmB). CR consisted in pelvic external beam radiotherapy with weekly cisplatin (40mg/m2) and brachytherapy. Extended-field radiation was performed in cases of confirmed paraaortic metastases.

Results Among 240 patients (n=121 ArmA;n=119 ArmB), 236(98.3%) received CR. Arms were balanced. Surgical approach was transperitoneal laparoscopy in 93.4%(mean 19pelvic/17paraaortic lymph nodes (LN). CR started 7–21days after surgery. Surgery upstaged 40/121(33%). Median follow-up: 66.5months. ArmA was superior for PFS (HR=1.38 ArmB vs. ArmA,p=0.115) and OS (HR=1.29,p=0.24). Clinically or surgically LN+ negatively impacted PFS (pelvic:HR=2.38,p=0.007; paraaortic:HR=2.84,p=0.001; anyLN+:HR=2.83,p=0.003) and OS (pelvic:HR=2.90,p=0.003; paraaortic:HR=3.03,p=0.001; anyLN+:HR=3.51,p=0.001). Adeno/adenosquamous were comparable to squamous cell carcinomas (PFS:HR=1.26, p=0.44, OS:HR=1.35, p=0.32). Stages III/IV had worse prognosis than IIb (PFS:HR=1.86, p=0.003; OS:HR=2.07, p=0.001).

Conclusions Although statistical significance could not be reached, surgical staging in LACC lead to superior DFS and OS compared to clinical staging with acceptable morbidity and no significant CR delay. The high risk of distant metastases in both arms underlies the need for further treatment intensification.

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