Clinical trial · Interventional
OVCA-NAC-P2: Study of Chemotherapy Followed by Cytoreductive Surgery for Ovarian, Tubal and Peritoneal Cancers: JCOG0206
Feasibility Study of Neoadjuvant Chemotherapy Followed by Interval Cytoreductive Surgery for Stage III/IV Ovarian, Tubal and Peritoneal Cancers: JCOG0206
NCT00112086CI-TRIAL-00023729completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Neoplasms | Fallopian Tube Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Peritoneal Neoplasms | Peritoneal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant chemotherapy (Paclitaxel and Carboplatin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- proportion of clinical complete remission
Secondary outcomes (10)
- measure
- positive predictive value (PPV) of prelaparoscopic diagnosis concerning the origin and histology
- measure
- proportion of the patients diagnosed as müllerian carcinoma by laparoscopic inspection and histopathology of biopsy specimen among those diagnosed by prelaparoscopic findings
- measure
- 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
- measure
- 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
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDOnda 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. PMID 15020662
- DERIVEDOnda 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. PMID 19181369