OVCA-NAC-P2: Study of Chemotherapy Followed by Cytoreductive Surgery for Ovarian, Tubal and Peritoneal Cancers: JCOG0206
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A feasibility study of neoadjuvant chemotherapy (NAC) followed by interval cytoreductive surgery (ICS) and postoperative chemotherapy for stage III/IV mullerian carcinomas such as ovarian, tubal and peritoneal carcinomas.
Drug: Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)
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.
positive predictive value (PPV) of prelaparoscopic diagnosis concerning the origin and histology
proportion of the patients diagnosed as müllerian carcinoma by laparoscopic inspection and histopathology of biopsy specimen among those diagnosed by prelaparoscopic findings
PPV of prelaparoscopic diagnosis concerning clinical stage; proportion of the patients diagnosed as stage III or IV by laparoscopic inspection among those diagnosed by prelaparoscopic findings
PPV of overall prelaparoscopic diagnosis; proportion of the patients diagnosed as stage III or IV müllerian carcinoma by laparoscopic inspection and histopathology of biopsy specimen among those diagnosed by prelaparoscopic findings
response rate to NAC among patients whose clinical diagnosis is confirmed by laparoscopy
proportion of patients who received interval cytoreductive surgery (ICS) among patients whose clinical diagnosis is confirmed by laparoscopy
progression-free survival among patients whose clinical diagnosis is confirmed by laparoscopy
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Ages Eligible for Study:
20 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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
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