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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00112086
First received: May 27, 2005
Last updated: February 29, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Drug: Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study of Neoadjuvant Chemotherapy Followed by Interval Cytoreductive Surgery for Stage III/IV Ovarian, Tubal and Peritoneal Cancers: JCOG0206

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • proportion of clinical complete remission

Secondary Outcome Measures:
  • 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.

Enrollment: 56
Study Start Date: January 2003
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112086

Locations
Japan
National Cancer Center
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 1040045
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Hiroyuki Yoshikawa, MD University of Tsukuba
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hiroyuki Yoshikawa , MD, Study Chair, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00112086     History of Changes
Other Study ID Numbers: JCOG0206, C000000005
Study First Received: May 27, 2005
Last Updated: February 29, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:
ovarian neoplasms
laparoscopy
neoadjuvant therapy
interval cytoreductive surgery

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014