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

Ovarian Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00112086
• Other study ID #: JCOG0206
• Secondary ID: C000000005
• Status: Completed
• Phase: Phase 2
• First received: May 27, 2005
• Last updated: August 30, 2016
• Start date: January 2003
• Est. completion date: February 2007

Study information

• Verified date: August 2016
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Neoplasms
• Neoplasms
• Ovarian Neoplasms
• Peritoneal Neoplasms

Intervention

Drug:
• Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)

Locations

Country	Name	City	State
Japan	National Cancer Center	Tsukiji, 5-1-1, Chuo-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Japan Clinical Oncology Group	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of clinical complete remission
Secondary	positive predictive value (PPV) of prelaparoscopic diagnosis concerning the origin and histology
Secondary	proportion of the patients diagnosed as müllerian carcinoma by laparoscopic inspection and histopathology of biopsy specimen among those diagnosed by prelaparoscopic findings
Secondary	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
Secondary	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
Secondary	response rate to NAC among patients whose clinical diagnosis is confirmed by laparoscopy
Secondary	proportion of patients who received interval cytoreductive surgery (ICS) among patients whose clinical diagnosis is confirmed by laparoscopy
Secondary	progression-free survival among patients whose clinical diagnosis is confirmed by laparoscopy
Secondary	operative morbidity among all enrolled patients
Secondary	adverse events among all enrolled patients, and
Secondary	overall survival among all enrolled patients.

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