Phase I-II trial of preoperative chemoradiation in locally advanced cervical carcinorna

Salvatore Mancuso, Daniela Smaniotto, Pierluigi Benedetti Panici, Barbara Favale, Stefano Greggi, Riccardo Manfredi, P. Alessandro Margariti, Alessio G. Morganti, Giovanni Scambia, Francesca Tortoreto, Vincenzo Valentini, Numa Cellini

Research output: Contribution to journalArticlepeer-review


Background. 5-Fluorouracil and cisplatin are characterized by in vitro synergism as well as radiosensitization. A phase I-II study was carried out on patients with invasive cervical carcinoma (FIGO IIB-IIIA) undergoing concomitant chemoradiation with 5-fluorouracil and cisplatin followed by radical surgery. Methods. Twenty-six patients of 53 years median age, 24 with IIB rumor and 2 with IIIA tumor, all with squamous carcinoma, entered the study. The chemoradiation protocol included external radiotherapy to the pelvis: 39.6 Gy (180 cGy/daily); 5-fluorouracil: 1 g/m2/daily, in continuous intravenous infusion days 1-4 and 27-30; cisplatin: 20 mg/m2/daily days 1-4 and 27-30. Four weeks after the end of chemoradiotherapy, patients underwent restaging and then radical surgery with pelvic and lumboaortic lymphadenectomy. Results. Twenty-six patients are evaluable for acute toxicity and 24 are evaluable for objective and pathologic response. Grade 3-4 thrombocytopenia or leukopenia was observed in 6 patients and grade 3 acute gastrointestinal toxicity in 3. After chemoradiation CR and PR were observed in 64 and 36% of cases, respectively (CR + PR = 100%). Two patients were excluded from surgery for other diseases. The remaining 24 patients were operated on; 23/24 patients showed negative section margins. The histology of the surgical specimen showed the absence of disease in 13 patients (54.2%), microscopic residual tumor in 4 patients (16.6%), residual disease ≤1 cm in 5 patients, and residual disease >1 cm in 2 patients. Median follow up was 33 months. Two-year actuarial local control was 91.7%. Conclusions. This study showed a particularly high rate of pathologic responses (complete + Tmic: 70.8%) and local control (2 years = 91.7%) in patients with advanced cervical cancer undergoing moderate doses of radiotherapy with concomitant chemotherapy followed by radical surgery. (C) 2000 Academic Press.

Original languageEnglish
Pages (from-to)324-328
Number of pages5
JournalGynecologic Oncology
Issue number3 I
Publication statusPublished - 2000


  • Cervical neoplasms
  • Combined modality therapy
  • Concomitant chemoradiation
  • Surgery

ASJC Scopus subject areas

  • Obstetrics and Gynaecology
  • Oncology


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