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

Sponsor

Japan Clinical Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00112086

Collaborator

Ministry of Health, Labour and Welfare, Japan (Other)

Enrollment

Location

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Neoplasms Fallopian Tube Neoplasms Peritoneal Neoplasms	Drug: Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Feasibility Study of Neoadjuvant Chemotherapy Followed by Interval Cytoreductive Surgery for Stage III/IV Ovarian, Tubal and Peritoneal Cancers: JCOG0206

Study Start Date :

Jan 1, 2003

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Outcome Measures

Primary Outcome Measures

proportion of clinical complete remission []

Secondary Outcome Measures

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 []
operative morbidity among all enrolled patients []
adverse events among all enrolled patients, and []
overall survival among all enrolled patients. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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