15020 Background: Retrospective analyses revealed that survival of ovarian cancer patients treated with NAC followed by IDS was comparable with those treated by standard treatment starting with primary debulking surgery. The purpose is to assess the safety and efficacy of the NAC setting treatment and also to know whether we can accurately diagnose the cancer by imaging studies, cytologic findings and tumor markers without diagnostic laparoscopy (DLS). Methods: The study was performed as a multi-institutional non-randomized phase II trial. Eligibility included stage III/IV müllerian carcinoma (MC) such as ovarian, tubal and peritoneal carcinomas diagnosed by imaging studies (CT and/or MRI), cytology of ascites, pleural effusions or fluids obtained by tumor centesis, CA125 >200 U/ml and CEA<20 ng/ml. After study enrollment, DLS is performed to confirm tumor origin, histology and stage. Four cycles of combination of paclitaxel (175 mg/m2, 3h) and carboplatin (AUC 6) are administered as NAC, followed by IDS and additional 4 cycles of chemotherapy. Primary endpoint is proportion of clinical complete remission (% cCR) with CA 125<20 U/ml among all stage III/IV MC confirmed by DLS (expected % cCR of 40% and threshold % cCR of 20%). Major secondary endpoint is positive predictive value (PPV) of clinical diagnoses concerning origin, histology and stage (expected PPV>90%, then DLS will be omitted in the next phase III study). The planned sample size was 56 eligibles, which gives 10% or lower Bayesian posterior probability that PPV is < 90% in case of three false positives. Results: Fifty six patients were enrolled between Jan/2003 and Feb/2004. All patients had accurate pre-DLS diagnosis concerning origin and histology. In 53 (PPV 94.6%) of 56 patients, tumor stage was accurately diagnosed. Twenty nine (62%) of 47 patients who underwent IDS had complete resection without residual tumors. Nineteen (%cCR 36%) among 53 patients with stage III/IV MC achieved cCR at completion of planned treatment. Conclusions: NAC starting without DLS followed by IDS for advanced MC is a promising treatment to be compared with the current standard treatment in a phase III study. [Table: see text]
Phase III Trial of Upfront Debulking Surgery Versus Neoadjuvant Chemotherapy for Stage III/IV Ovarian, Tubal and Peritoneal Cancers: Japan Clinical Oncology Group Study JCOG0602