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

NCT ID: NCT00112086

Last Updated: 2016-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2007-02-28

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.

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Labour and Welfare, Japan

OTHER_GOV

Sponsor Role: collaborator

Japan Clinical Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Japan Clinical Oncology Group

Principal Investigators

Hiroyuki Yoshikawa, MD

Role: STUDY_CHAIR

University of Tsukuba

Locations

National Cancer Center

Tsukiji, 5-1-1, Chuo-ku, Tokyo, Japan

Countries

Japan

References

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.

Reference Type: BACKGROUND

PMID: 15020662 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19181369 (View on PubMed)

Related Links

http://www.jcog.jp/

Related Info

Other Identifiers

C000000005

Identifier Type: -

Identifier Source: secondary_id

JCOG0206

Identifier Type: -

Identifier Source: org_study_id