The purposes of this study are to assess the safety and efficacy of the treatment starting with neoadjuvant chemotherapy (NAC) with paclitaxel and carboplatin (CBDCA) for a phase III study comparing NAC therapy with current standard procedures, and to know whether we can accurately diagnose these advanced carcinomas by imaging studies, cytologic findings, and tumor markers without staging laparotomy or laparoscopy.

Condition	Treatment or Intervention	Phase
Ovarian Neoplasms Fallopian Tube Neoplasms	Drug: Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)	Phase II

Further Study Details: 

Primary Outcomes: proportion of clinical complete remission
Secondary Outcomes: 1) 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; 2) 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; 3) 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; 4) response rate to NAC among patients whose clinical diagnosis is confirmed by laparoscopy; 5) proportion of patients who received ICS among patients whose clinical diagnosis is confirmed by laparoscopy; 6) progression-free survival among patients whose clinical diagnosis is confirmed by laparoscopy; 7) operative morbidity among all enrolled patients; 8) adverse events among all enrolled patients, and; 9) overall survival among all enrolled patients.
Expected Total Enrollment:  56

Ages Eligible for Study:  20 Years   -   75 Years,  Genders Eligible for Study:  Female

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00112086

Takashi Onda, MD      81-3-3542-2511    webmaster@ml.jco.jp
Hiroyuki Yoshikawa, MD      81-29-853-3049    webmaster@ml.jco.jp

Japan, Tokyo
      National Cancer Center, 5-1-1,Tsukiji,Chuo-ku,  Tokyo,  1040045,  Japan; Recruiting

Study ID Numbers:  JCOG0206
Record last reviewed:  May 2005
Last Updated:  May 27, 2005
Record first received:  May 27, 2005
ClinicalTrials.gov Identifier:  NCT00112086
Health Authority: Japan: Ministry of Health, Labor and Welfare (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-05-31