Back to resultsOVCA-NAC-P2: Study of Chemotherapy Followed by Cytoreductive Surgery for Ovarian, Tubal and Peritoneal Cancers: JCOG0206
Primary Purpose
Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Neoplasms focused on measuring ovarian neoplasms, laparoscopy, neoadjuvant therapy, interval cytoreductive surgery
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
Sites / Locations
- National Cancer Center
Outcomes
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.
Full Information
NCT ID
NCT00112086
First Posted
May 27, 2005
Last Updated
August 30, 2016
Sponsor
Japan Clinical Oncology Group
Collaborators
Ministry of Health, Labour and Welfare, Japan
1. Study Identification
Unique Protocol Identification Number
NCT00112086
Brief Title
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
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Japan Clinical Oncology Group
Collaborators
Ministry of Health, Labour and Welfare, Japan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms
Keywords
ovarian neoplasms, laparoscopy, neoadjuvant therapy, interval cytoreductive surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)
Primary Outcome Measure Information:
Title
proportion of clinical complete remission
Secondary Outcome Measure Information:
Title
positive predictive value (PPV) of prelaparoscopic diagnosis concerning the origin and histology
Title
proportion of the patients diagnosed as müllerian carcinoma by laparoscopic inspection and histopathology of biopsy specimen among those diagnosed by prelaparoscopic findings
Title
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
Title
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
Title
response rate to NAC among patients whose clinical diagnosis is confirmed by laparoscopy
Title
proportion of patients who received interval cytoreductive surgery (ICS) among patients whose clinical diagnosis is confirmed by laparoscopy
Title
progression-free survival among patients whose clinical diagnosis is confirmed by laparoscopy
Title
operative morbidity among all enrolled patients
Title
adverse events among all enrolled patients, and
Title
overall survival among all enrolled patients.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroyuki Yoshikawa, MD
Organizational Affiliation
University of Tsukuba
Official's Role
Study Chair
Facility Information:
Facility Name
National Cancer Center
City
Tsukiji, 5-1-1, Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
1040045
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
15020662
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.
Results Reference
background
PubMed Identifier
19181369
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.
Results Reference
derived
Links:
URL
http://www.jcog.jp/
Description
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OVCA-NAC-P2: Study of Chemotherapy Followed by Cytoreductive Surgery for Ovarian, Tubal and Peritoneal Cancers: JCOG0206
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