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

NCT00112086CompletedPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Japan Clinical Oncology Group

Enrollment

56

Start Date

2003-01-01

Completion Date

2007-02-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)

Conditions

Ovarian NeoplasmsFallopian Tube NeoplasmsPeritoneal Neoplasms

Eligibility

Age Range

20 Years – 75 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

proportion of clinical complete remission

Secondary Outcomes

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.

Locations

National Cancer Center, Tsukiji, 5-1-1, Chuo-ku, Japan

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