Phase III trial of upfront debulking surgery vs. neoadjuvant chemotherapy for stage III/IV ovarian, tubal and peritoneal cancers (JCOG0602, OV-NACTC-P3)

Conditions

stage III/IV mullerian carcinomas such as ovarian, tubal and peritoneal carcinomas

Takashi Onda, Yumiko Tanaka, Satomi Kitai, Tomoko Manabe, Mitsuya Ishikawa et al. (12 authors)

Japanese Journal of Clinical Oncology2020-08-1215 citations

Comparison of survival between primary debulking surgery and neoadjuvant chemotherapy for stage III/IV ovarian, tubal and peritoneal cancers in phase III randomised trial.

Onda T, Satoh T, Ogawa G, Saito T, Kasamatsu T, Nakanishi T, Mizutani T, Takehara K, Okamoto A, Ushijima K, Kobayashi H, Kawana K, Yokota H, Takano M, Kanao H, Watanabe Y, Yamamoto K, Yaegashi N, Kamura T, Yoshikawa H, Japan Clinical Oncology Group.

2020-03-13142 citations

10.1016/j.ejca.2020.02.020

Comparison of survival between upfront primary debulking surgery versus neoadjuvant chemotherapy for stage III/IV ovarian, tubal and peritoneal cancers in phase III randomized trial: JCOG0602.

Takashi Onda, Toyomi Satoh, Toshiaki Saito, Takahiro Kasamatsu, Toru Nakanishi et al. (20 authors)

Journal of Clinical Oncology2018-05-2045 citations

10.1200/jco.2018.36.15_suppl.5500

Comparison of treatment invasiveness between upfront debulking surgery versus interval debulking surgery following neoadjuvant chemotherapy for stage III/IV ovarian, tubal, and peritoneal cancers in a phase III randomised trial: Japan Clinical Oncology Group Study JCOG0602.

Onda T, Satoh T, Saito T, Kasamatsu T, Nakanishi T, Nakamura K, Wakabayashi M, Takehara K, Saito M, Ushijima K, Kobayashi H, Kawana K, Yokota H, Takano M, Takeshima N, Watanabe Y, Yaegashi N, Konishi I, Kamura T, Yoshikawa H, Japan Clinical Oncology Group.

2016-06-17166 citations

10.1016/j.ejca.2016.05.017

Accuracy of preoperative imaging diagnosis as a possible new staging system in advanced ovarian, tubal, and peritoneal cancer: Using data from Japan Clinical Oncology Group study JCOG0602.

Takashi Onda, Yumiko Tanaka, Mitsuya Ishikawa, Yoko Hasumi, Satomi Kitai et al. (17 authors)

Journal of Clinical Oncology2016-05-20

10.1200/jco.2016.34.15_suppl.e17074

Comparison of treatment invasiveness between upfront debulking surgery versus interval debulking surgery following neoadjuvant chemotherapy for stage III/IV ovarian, tubal, and peritoneal cancers in phase III randomized trial: JCOG0602.

Takashi Onda, Hiroyuki Yoshikawa, Taro Shibata, Kenichi Nakamura, Toyomi Satoh et al. (20 authors)

Journal of Clinical Oncology2014-05-2015 citations

10.1200/jco.2014.32.15_suppl.5508

Interventions

A: Primary debulking surgery followed by chemotherapy B: Neoaduvant chemptherapy followed by interval debulking surgery

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) stage III or IV mullerian carcinoma by clinical findings including imaging studies (CT or MRI) and cytology of ascites, pleural effusions, or fluids obtained by tumor centesis 2) clinically deemed to be a candidate for debulking surgery without evidence of brain, bone, bone marrow metastasis 3) CA125>200U/mL and CEA<20ng/mL 4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3 5) presence of any measurable lesions is not required 6) previously untreated for these malignancies and no history of treatment with chemotherapy nor radiotherapy even for other diseases 7) adequate bone marrow, hepatic, renal, cardiac and respiratory functions 8) written informed consent

Exclusion criteria

Exclusion criteria: 1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 2) pregnant or nursing 3) severe mental disorders 4) systemic and continuous use of steroidal drugs 5) positive for serum hepatitis B surface antigen 6) active infections 7) uncontrolled hypertension 8) diabetes mellitus, uncontrolled or controlled with insulin 9) history of cardiac failure, unstable angina, myocardial infarction within 6 months prior to the registration 10) hypersensitivity to polyoxyethylated castor oill 11) intestinal occlusion necessary for surgical treatment 12) hypersensitivity to alcohol

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
proportion of clinical complete remission, progression free survival, response rate, adverse event, surgical invasiveness	—

Countries

Japan

Contacts

Public ContactTakashi Onda

JCOG0602 Coordinating Office Department of Obstetrics and Gynecology School of Medicine, Kitasato University Hospital

JCOG_sir@ml.jcog.jp042-778-8111

Outcome results

None listed