OVCA-NAC-P2: Study of Chemotherapy Followed by Cytoreductive Surgery for Ovarian, Tubal and Peritoneal Cancers: JCOG0206
This study has been completed.
Sponsor:
Japan Clinical Oncology Group
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
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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) |
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
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:
|
Neoplasms Fallopian Tube Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Fallopian Tube Diseases Adnexal Diseases Genital Diseases, Female Endocrine Gland Neoplasms Ovarian Diseases Endocrine System Diseases Gonadal Disorders |
Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 21, 2013