Spots Global Cancer Trial Database for Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial
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Trial Identification
Brief Title: Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial
Official Title: A Randomized Phase II/III Trial of Intravenous (IV) Paclitaxel Weekly Plus IV Carboplatin Once Every 3 Weeks Versus IV Paclitaxel Weekly Plus Intraperitoneal (IP) Carboplatin Once Every 3 Weeks in Women With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Study ID: NCT01506856
Study Description
Brief Summary: The purpose of this study is: Phase A: To confirm the feasibility of paclitaxel administered by intravenous (IV) infusion weekly plus concurrent carboplatin administered by intraperitoneal (IP) injection once every 3 weeks (dd-TCip therapy). Phase B: To compare the efficacy and safety of the following two treatment regimens as first-line chemotherapy in women with epithelial ovarian, Fallopian tube or primary peritoneal cancer.
Detailed Description: This is a randomized, multicenter international study. Patient are stratified according to Residual tumor diameter(\[0cm(No residual)\] vs. \[0cm\<residual\<1cm\] vs. \[1cm\<residual\<2cm\] vs. \[\>2 cm\]), FIGO stage(StageII vs. III vs. IV) and institution. Patient randomized to one of the treatment arms described below. RegimenI(Standard treatment: dd-TCiv therapy): Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IV infusion once every 3 weeks RegimenII(Study treatment: dd-TCip therapy): Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IP injection once every 3 weeks The 3-week period (21 days) is 1 cycle. Protocol treatment basically comprises 6 cycles. IDS is allowed to be performed after 3, 4 or 5 cycles of the protocol treatment. In such cases, the protocol treatment must be restarted within 8 weeks after IDS. If IDS is performed, patients can receive up to 3 additional cycles of the protocol treatment after IDS. If interval debulking surgery (IDS) is performed after 3, 4 or 5 cycles, the patients can receive up to 3 additional cycles of the protocol treatment. A total of 6 to 8 cycles will be repeated. The analysis of efficacy will be performed on all randomized subjects in accordance with the intention-to-treat (ITT) principle. In order to assess the robustness of the results, the same analyses will be done using all randomized subjects who satisfy the eligibility criteria. The analysis of safety will be performed on all subjects who have received at least one dose of study treatment.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
Queen Mary Hospital, Hong Kong, High West, Hong Kong
Aichi Cancer Center Hospital, Chikusa, Aichi, Japan
Hirosaki University School of Medicine & Hospital, Hirosaki-shi, Aomori, Japan
The Jikei University School of Medicine, Kashiwa Hospital, Kashiwa, Chiba, Japan
NHO Shikoku Cancer Center, Matsuyama, Ehime, Japan
Ehime University Hospital, Toon-shi, Ehime, Japan
University of Fukui Hospital, Yoshida, Fukui, Japan
Gunma University Hospital, Maebashi, Gunma, Japan
Gunma Prefectural Cancer Center, Ōta, Gunma, Japan
NHO Kure Medical Center And Chugoku Cancer Center, Kure, Hiroshima, Japan
Miyoshi Central Hospital, Miyoshi, Hiroshima, Japan
Hyogo Cancer Center, Akashi, Hyogo, Japan
Japanese Red Cross Society Himeji Hospital, Himeji, Hyogo, Japan
Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan
Hyogo Medical College Hospital, Nishinomiya, Hyogo, Japan
Tsukuba University Hospital, Tsukuba, Ibaraki, Japan
Iwate Medical University Hospital, Morioka, Iwate, Japan
Tokai University Hospital, Isehara, Kanagawa, Japan
Nippon Medical University Musasi Kosugi Hospital, Kawasaki-shi, Kanagawa, Japan
Yokohama Municipal Citizen's Hospital, Yokohama, Kanagawa, Japan
Mie University Hospital, Tsu, Mie, Japan
Mie Prefectural General Medical Center, Yokkaichi, Mie, Japan
Tohoku University Hospital, Sendai, Miyagi, Japan
Shinshu University Hospital, Matsumoto, Nagano, Japan
Nara Medical Univeｒsity Hospital, Kashihara, Nara, Japan
Okinawa Prefectural Chubu Hospital, Uruma, Okinawa, Japan
Kaizuka City Hospital, Kaizuka, Osaka, Japan
Osaka University Hospital, Suita, Osaka, Japan
Osaka Medical College Hospital, Takatsuki, Osaka, Japan
Saitama Medical University International Medical Center, Hidaka, Saitama, Japan
Saitama Medical University Saitama Medical Center, Kawagoe, Saitama, Japan
Shizuoka Cancer Center, Nagaizumi, Shizuoka, Japan
Jichi Medical University Hospital, Shimotsuke, Tochigi, Japan
Tochigi Cancer Center, Utsunomiya, Tochigi, Japan
Juntendo University Hospital, Bunkyo, Tokyo, Japan
The University of Tokyo Hospital, Bunkyō-Ku, Tokyo, Japan
The Jikei University Daisan Hospital, Komae, Tokyo, Japan
The Cancer Institute Hospital Of JFCR, Koto-Ku, Tokyo, Japan
The Jikei University Hospital, Minato-Ku, Tokyo, Japan
Showa University Hospital, Shinagawa-Ku, Tokyo, Japan
Keio University Hospital, Shinjuku-Ku, Tokyo, Japan
Tokyo Women's Medical University Medical Center East, Shinjuku-Ku, Tokyo, Japan
Tottori University, Yonago, Tottori, Japan
Yamaguchi University Hospital, Ube, Yamaguchi, Japan
NHO Kyusyu Medical center, Fukuoka, , Japan
JA Hiroshima General Hospital, Hiroshima, , Japan
Kagoshima City Hospital, Kagoshima, , Japan
University Hospital, Kyoto Prefectural University of Medicine, Kyoto, , Japan
Saiseikai Nagasaki Hospital, Nagasaki, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Niigata University Medical & Dental Hospital, Niigata, , Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, , Japan
Tottori Municipal Hospital, Tottori, , Japan
Korea Cancer Center Hospital, Seoul, Gongneung-Dong, Korea, Republic of
Gangnam Severance Hospital in Korea, Dogok, Seoul, Korea, Republic of
Asan Medical Center, P'ungnap-tong, Seoul, Korea, Republic of
Ewha Womans University Medical Center, Yangcheon, Seoul, Korea, Republic of
Shinchon Severance Hospital, Seoul, Shinchon, Korea, Republic of
University of Otago - Christchurch/Christchurch Women's Hospital, Christchurch, , New Zealand
KK Women's and Children's Hospital, Bukit Timah, , Singapore
National University Hospital of Singapore, Kent Ridge, , Singapore
Contact Details
Name: Keiichi Fujiwara, MD, PhD
Affiliation: Saitama Medical University International Medical Center Comprehensive Cancer Center
Role: STUDY_CHAIR
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