Status:
COMPLETED
OVCA-NAC-P2: Study of Chemotherapy Followed by Cytoreductive Surgery for Ovarian, Tubal and Peritoneal Cancers: JCOG0206
Lead Sponsor:
Japan Clinical Oncology Group
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Eligibility:
FEMALE
20-75 years
Phase:
PHASE2
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 p...
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00112086
Start Date
January 1 2003
End Date
February 1 2007
Last Update
August 31 2016
Active Locations (1)
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1
National Cancer Center
Tsukiji, 5-1-1, Chuo-ku, Tokyo, Japan, 1040045