Fallopian Tube Neoplasms, Ovarian Neoplasms, Peritoneal Neoplasms
Conditions
Keywords
ovarian neoplasms, laparoscopy, neoadjuvant therapy, interval cytoreductive surgery
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.
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.
Interventions
Sponsors
Ministry of Health, Labour and Welfare, Japan
Japan Clinical Oncology Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proportion of clinical complete remission | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| 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 | — |
| 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 | — |
| overall survival among all enrolled patients. | — |
| adverse events among all enrolled patients, and | — |
Countries
Japan
Outcome results
None listed