Results of a prospective randomized trial with neoadjuvant chemotherapy in stage IB, bulky, squamous carcinoma of the cervix.

A prospective randomized trial was carried out in patients with squamous carcinoma of the cervix uteri, stage Ib bulky. The protocol considers two arms: the control group (75 patients) and the neoadjuvant one (76 patients). All the patients were classified according to the FIGO staging system and in order to determine the tumor size objectively, an ultrasound scanning was done. After this a Wertheim-Meigs operation followed by adjuvant whole-pelvis irradiation was performed. In the neoadjuvant group the same procedures were carried out but three courses of chemotherapy with the "quick" VBP scheme were given before the treatment. The new therapeutic strategy proved to be very useful in bulky tumors in which the clinical examination showed a cervix increased in size and the ultrasound scanning a volume larger than 60 c.c. (> 4 x 4 x 4 cm). In those cases statistically significant differences were found between both groups when free disease interval and survival were considered. These were due to the fact that operability has been improved and the parametrial extension has been decreased as well as other risk factors such as vascular embolism, lymph node involvement, tumor-cervix quotient, and tumor volume. The use of this new strategy is not justified in small tumors (< 3-4 cm in diameter) because in those cases, survival is not improved with neoadjuvant therapy.

RCT Entities:   Population Interventions Outcomes