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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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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