Clinical trial NCT00112086: OVCA-NAC-P2: Study of Chemotherapy Followed by Cytoreductive Surgery for Ovarian, Tubal and Peritoneal Cancers: JCOG0206
Official title: Feasibility Study of Neoadjuvant Chemotherapy Followed by Interval Cytoreductive Surgery for Stage III/IV Ovarian, Tubal and Peritoneal Cancers: JCOG0206
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Keywords: ovarian neoplasms
laparoscopy
neoadjuvant therapy
interval cytoreductive surgery
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-05-30
Enrollment: 56
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: proportion of clinical complete remission
Secondary outcomes:
measure: positive predictive value (PPV) of prelaparoscopic diagnosis concerning the origin and histology
measure: proportion of the patients diagnosed as müllerian carcinoma by laparoscopic inspection and histopathology of biopsy specimen among those diagnosed by prelaparoscopic findings
measure: 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
measure: 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
measure: response rate to NAC among patients whose clinical diagnosis is confirmed by laparoscopy
measure: proportion of patients who received interval cytoreductive surgery (ICS) among patients whose clinical diagnosis is confirmed by laparoscopy
measure: progression-free survival among patients whose clinical diagnosis is confirmed by laparoscopy
measure: operative morbidity among all enrolled patients
measure: adverse events among all enrolled patients, and
measure: overall survival among all enrolled patients.
Other outcomes:
Locations:
city: Tsukiji, 5-1-1, Chuo-ku
country: Japan
facility: National Cancer Center
state: Tokyo
Study officials:
affiliation: University of Tsukuba
name: Hiroyuki Yoshikawa, MD
role: STUDY_CHAIR
References:
citation: Onda T, Kamura T, Ishizuka N, Katsumata N, Fukuda H, Yoshikawa H; Japan Clinical Oncology Group Study JCOG0206. Feasibility study of neoadjuvant chemotherapy followed by interval cytoreductive surgery for stage III/IV ovarian, tubal and peritoneal cancers: Japan Clinical Oncology Group Study JCOG0206. Jpn J Clin Oncol. 2004 Jan;34(1):43-5. doi: 10.1093/jjco/hyh007.
citation: Onda T, Kobayashi H, Nakanishi T, Hatae M, Iwasaka T, Konishi I, Shibata T, Fukuda H, Kamura T, Yoshikawa H. Feasibility study of neoadjuvant chemotherapy followed by interval debulking surgery for stage III/IV ovarian, tubal, and peritoneal cancers: Japan Clinical Oncology Group Study JCOG0206. Gynecol Oncol. 2009 Apr;113(1):57-62. doi: 10.1016/j.ygyno.2008.12.027. Epub 2009 Jan 31.