OVCA-NAC-P2: Study of Chemotherapy Followed by Cytoreductive Surgery for Ovarian, Tubal and Peritoneal Cancers: JCOG0206

The purposes are to assess the safety and efficacy of the treatment starting with NAC and to know whether we can accurately diagnose these advanced carcinomas by imaging studies, cytologic findings and tumor markers without staging laparotomy or laparoscopy. Fifty-six patients with advanced mullerian carcinomas will be recruited to the study. After confirmation of diagnosis by laparoscopic inspection and biopsies, patients undergo 4 cycles of chemotherapy as NAC followed by ICS and additional 4 cycles of postsurgical chemotherapy. The primary endpoint is proportion of clinical complete remission after accomplishment of the protocol treatment and the major secondary endpoint is positive predictive value of diagnosis before laparoscopy regarding tumor origin, histology and stage. Based on the result of this study, we will conduct a phase III study to compare the treatment starting with NAC and primary cytoreductive surgery followed by postsurgical chemotherapy.

Inclusion criteria

• Stage III or IV müllerian carcinoma by prelaparoscopic clinical findings including imaging studies (CT, MRI or ultrasonography)
• Cytology of ascites, pleural effusions, or fluids obtained by tumor centesis
• Malignancies of other origins, such as breasts and digestive tract, should be excluded by endoscopy, opaque enema, or ultrasonography when these malignancies are suspected from symptoms, physical examinations or imaging diagnosis.
• CA125>200U/ml and CEA<20ng/ml.
• Clinically deemed to be a candidate for debulking surgery without evidence of brain, bone, bone marrow metastases, multiple lung, or multiple liver metastases
• Presence of at least one measurable lesion
• Previously untreated for these malignancies and no history of treatment with chemotherapy or radiotherapy even for other diseases
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3,
• Adequate bone marrow, hepatic, renal, cardiac and respiratory functions, and
• Written informed consent.

Exclusion criteria

• Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
• Pregnant or nursing
• Severe mental disorders
• Systemic and continuous use of steroidal drugs
• Active infections
• Uncontrolled hypertension
• Diabetes mellitus, uncontrolled or controlled with insulin
• History of cardiac failure, unstable angina, myocardial infarction within 6 months prior to the registration
• Liver cirrhosis or bleeding tendency contraindicating debulking surgery
• Intestinal occlusion necessary for surgical treatment
• Hypersensitivity to alcohol