Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial
- Conditions
- Epithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal Carcinoma
- Interventions
- Drug: Paclitaxel(intravenous) + Carboplatin(intraperitoneal)Drug: Paclitaxel(intravenous) + Carboplatin(intravenous)
- Registration Number
- NCT01506856
- Lead Sponsor
- Gynecologic Oncology Trial & Investigation Consortium
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 655
-
Patients assumed to have a stageII-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer as a pre-surgery diagnosis
-
Patients scheduled to undergo laparotomy
*Both optimal and suboptimal patients will be eligible for the study (Suboptimal patients, as well as those who undergo only exploratory laparotomy, are eligible.)
-
ECOG Performance Status: 0-2
-
Patients who provide consent for placement of the IP port system, if randomized to Regimen II (Study treatment: dd-TCip therapy)
-
Patients expected to receive the first protocol treatment within 8 weeks after the comprehensive staging surgery
-
Lab data and clinical examination: Data within 28 days before the scheduled date of surgery
- Neutrophil count ≧ 1,500 /mm3
- Platelet count ≧ 100,000 /mm3
- AST (GOT) ≦ 100 IU/L
- ALT (GPT) ≦ 100 IU/L
- Total bilirubin < 1.5 mg/dL
- Serum Creatinine < 1.5 mg/dL
- Electrocardiogram (ECG): Patients with normal ECG, Asymptomatic patients with abnormal ECGs not requiring medical intervention
- Neuropathy(Both motor and sensory) ≦ Grade1 (CTCAE Version 4.0)
-
Patients expected to survive longer than 3 months from the start date of the protocol treatment
-
Patients aged 20 years and older at the time of tentative registration (with no upper age limit)
-
Patients who provide written informed consent for participation in this trial
- Patients assumed to have a borderline malignancy of the ovary, fallopian tube, or primary peritoneal cancer
- Patients who have received previous chemotherapy or radiation therapy to treat the current disease
- Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy (Patients with basal and squamous cell carcinoma of the skin, as well as carcinoma in situ, and intramucosal carcinoma cured by local treatment, are eligible for the study)
- Patients with serious medical complications, such as serious heart disease, cerebrovascular accidents, uncontrolled diabetes mellitus, uncontrolled hypertension, pulmonary fibrosis, interstitial pneumonitis, active bleeding, an active gastrointestinal ulcer, or a serious neurological disorder
- Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil
- Patients with a pleural effusion requiring continuous drainage
- Patients with an active infection requiring antibiotics
- Patients who are pregnant, nursing or of child-bearing potential
- Patients with evidence upon physical examination of brain tumor and any brain metastases
- Patients for whom completion of this study and/or follow-up is deemed inappropriate for any reason
- Patients with any signs/symptoms of interstitial pneumonia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study treatment: dd-TCip therapy Paclitaxel(intravenous) + Carboplatin(intraperitoneal) Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IP injection once every 3 weeks Standard treatment: dd-TCiv therapy Paclitaxel(intravenous) + Carboplatin(intravenous) Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IV infusion once every 3 weeks
- Primary Outcome Measures
Name Time Method Progression-free survival(PFS) From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed until 510 events are observed or until 3 years from the last patient is randomized to the study
- Secondary Outcome Measures
Name Time Method Quality of Life (QOL) assessments baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment Cost-utility analysis baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment Overall survival (OS) weekly during the protocl treatment, then every 3 months for the first 2 years, 6-month for the following 2 years, and once a year thereafter Tumor response (only patients with evaluable disease) every 2 cycles [after 2 cycles, after 4 cycles, after 6 cycles, (after 8 cycles)], the time of discontinuation of the protocol treatment and then at least annually during follow-up Adverse events weekly during the protocl treatment, then every 3 months for the first 2 years, 6-month for the following 2 years, and once a year thereafter Treatment completion rate After the last cycle of the protocol teatment
Trial Locations
- Locations (62)
NHO Kyusyu Medical center
🇯🇵Fukuoka, Japan
JA Hiroshima General Hospital
🇯🇵Hiroshima, Japan
Gunma University Hospital
🇯🇵Maebashi, Gunma, Japan
Miyoshi Central Hospital
🇯🇵Miyoshi, Hiroshima, Japan
Queen Mary Hospital
🇭🇰Hong Kong, High West, Hong Kong
Mie Prefectural General Medical Center
🇯🇵Yokkaichi, Mie, Japan
University Hospital, Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Kagoshima City Hospital
🇯🇵Kagoshima, Japan
Gangnam Severance Hospital in Korea
🇰🇷Dogok, Seoul, Korea, Republic of
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Hirosaki University School of Medicine & Hospital
🇯🇵Hirosaki-shi, Aomori, Japan
Aichi Cancer Center Hospital
🇯🇵Chikusa, Aichi, 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 Prefectural Cancer Center
🇯🇵Ōta, Gunma, Japan
NHO Kure Medical Center And Chugoku Cancer Center
🇯🇵Kure, Hiroshima, Japan
Hyogo Cancer Center
🇯🇵Akashi, Hyogo, Japan
Hyogo Medical College Hospital
🇯🇵Nishinomiya, Hyogo, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe, Hyogo, Japan
Japanese Red Cross Society Himeji Hospital
🇯🇵Himeji, Hyogo, Japan
Tsukuba University Hospital
🇯🇵Tsukuba, Ibaraki, Japan
Iwate Medical University Hospital
🇯🇵Morioka, Iwate, Japan
Tokai University Hospital
🇯🇵Isehara, Kanagawa, Japan
Yokohama Municipal Citizen's Hospital
🇯🇵Yokohama, Kanagawa, Japan
Nippon Medical University Musasi Kosugi Hospital
🇯🇵Kawasaki-shi, Kanagawa, Japan
Mie University Hospital
🇯🇵Tsu, Mie, Japan
Shinshu University Hospital
🇯🇵Matsumoto, Nagano, Japan
Tohoku University Hospital
🇯🇵Sendai, Miyagi, Japan
Okinawa Prefectural Chubu Hospital
🇯🇵Uruma, Okinawa, Japan
Nara Medical Univeｒsity Hospital
🇯🇵Kashihara, Nara, Japan
Kaizuka City Hospital
🇯🇵Kaizuka, Osaka, Japan
Osaka Medical College Hospital
🇯🇵Takatsuki, Osaka, Japan
Shizuoka Cancer Center
🇯🇵Nagaizumi, Shizuoka, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka, Saitama, Japan
Saitama Medical University Saitama Medical Center
🇯🇵Kawagoe, Saitama, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke, Tochigi, Japan
Tochigi Cancer Center
🇯🇵Utsunomiya, Tochigi, Japan
The Jikei University Hospital
🇯🇵Minato-Ku, Tokyo, Japan
Keio University Hospital
🇯🇵Shinjuku-Ku, Tokyo, Japan
Showa University Hospital
🇯🇵Shinagawa-Ku, Tokyo, Japan
Tottori University
🇯🇵Yonago, Tottori, Japan
Yamaguchi University Hospital
🇯🇵Ube, Yamaguchi, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata, Japan
Saiseikai Nagasaki Hospital
🇯🇵Nagasaki, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
🇯🇵Osaka, Japan
Niigata University Medical & Dental Hospital
🇯🇵Niigata, Japan
Asan Medical Center
🇰🇷P'ungnap-tong, Seoul, Korea, Republic of
Tottori Municipal Hospital
🇯🇵Tottori, Japan
KK Women's and Children's Hospital
🇸🇬Bukit Timah, Singapore
National University Hospital of Singapore
🇸🇬Kent Ridge, Singapore
University of Otago - Christchurch/Christchurch Women's Hospital
🇳🇿Christchurch, New Zealand
Ewha Womans University Medical Center
🇰🇷Yangcheon, Seoul, Korea, Republic of
Shinchon Severance Hospital
🇰🇷Seoul, Shinchon, Korea, Republic of
Osaka University Hospital
🇯🇵Suita, Osaka, Japan
Korea Cancer Center Hospital
🇰🇷Seoul, Gongneung-Dong, Korea, Republic of
The Cancer Institute Hospital Of JFCR
🇯🇵Koto-Ku, Tokyo, Japan
Juntendo University Hospital
🇯🇵Bunkyo, Tokyo, Japan
The Jikei University Daisan Hospital
🇯🇵Komae, Tokyo, Japan
The University of Tokyo Hospital
🇯🇵Bunkyō-Ku, Tokyo, Japan
Tokyo Women's Medical University Medical Center East
🇯🇵Shinjuku-Ku, Tokyo, Japan