Feasibility Study of Neoadjuvant Chemotherapy Followed by Interval Cytoreductive Surgery for Stage III/IV Ovarian, Tubal and Peritoneal Cancers: JCOG0206
20 Years
75 Years
Female
Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms
Trial Information
Feasibility Study of Neoadjuvant Chemotherapy Followed by Interval Cytoreductive Surgery for Stage III/IV 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
proportion of clinical complete remission
Principal Investigator
Hiroyuki Yoshikawa, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Tsukuba
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
JCOG0206
NCT ID:
NCT00112086
Start Date:
January 2003
Completion Date:
February 2007
Related Keywords:
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- ovarian neoplasms
- laparoscopy
- neoadjuvant therapy
- interval cytoreductive surgery
- Neoplasms
- Fallopian Tube Neoplasms
- Ovarian Neoplasms
- Peritoneal Neoplasms
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