Epithelial Ovarian CancerPhase 2/3iPoccNCT01506856
Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial
A Phase 2/3 study testing Paclitaxel(intravenous) + Carboplatin(intravenous) and Paclitaxel(intravenous) + Carboplatin(intraperitoneal) in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Gynecologic Oncology Trial & Investigation Consortium at 62 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- What is being tested?
- Paclitaxel(intravenous) + Carboplatin(intravenous) and Paclitaxel(intravenous) + Carboplatin(intraperitoneal)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 655 participants
- Where
- 62 sitesin 6 countries
- Study dates
- May 2010to 28 Feb 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
62 sites in 6 countries.
62 sites in 6 countries
Japan52 sites
Hyogo Cancer Center
Akashi, Hyōgo, 673-0021
Juntendo University Hospital
Bunkyo, Tokyo, 113-0033
The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, 113-8655
Aichi Cancer Center Hospital
Chikusa, Aichi-ken, 464-0021
NHO Kyusyu Medical center
Fukuoka, 810-8563
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298
Japanese Red Cross Society Himeji Hospital
Himeji, Hyōgo, 670-0063
Hirosaki University School of Medicine & Hospital
Hirosaki-shi, Aomori, 036-8203
JA Hiroshima General Hospital
Hiroshima, 730-0051
Tokai University Hospital
Isehara, Kanagawa, 259-1143
Kagoshima City Hospital
Kagoshima, 892-8580
Kaizuka City Hospital
Kaizuka, Osaka, 597-0015
Nara Medical Univeｒsity Hospital
Kashihara, Nara, 634-8522
The Jikei University School of Medicine, Kashiwa Hospital
Kashiwa, Chiba, 277-8567
Saitama Medical University Saitama Medical Center
Kawagoe, Saitama, 350-8550
Nippon Medical University Musasi Kosugi Hospital
Kawasaki-shi, Kanagawa, 211-8533
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
The Jikei University Daisan Hospital
Komae, Tokyo, 201-8601
The Cancer Institute Hospital Of JFCR
Koto-Ku, Tokyo, 135-8550
NHO Kure Medical Center And Chugoku Cancer Center
Kure, Hiroshima, 737-0023
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, 602-0841
Gunma University Hospital
Maebashi, Gunma, 371-8511
Shinshu University Hospital
Matsumoto, Nagano, 390-0802
NHO Shikoku Cancer Center
Matsuyama, Ehime, 791-0245
The Jikei University Hospital
Minato-Ku, Tokyo, 105-8471
Miyoshi Central Hospital
Miyoshi, Hiroshima, 728-8502
Iwate Medical University Hospital
Morioka, Iwate, 020-8505
Saiseikai Nagasaki Hospital
Nagasaki, 850-0003
Shizuoka Cancer Center
Nakatogari, Shizuoka, 411-8777
Niigata Cancer Center Hospital
Niigata, 951-8133
Niigata University Medical & Dental Hospital
Niigata, 951-8520
Hyogo Medical College Hospital
Nishinomiya, Hyōgo, 663-8501
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, 537-8511
Gunma Prefectural Cancer Center
Ōta, Gunma, 373-8550
Tohoku University Hospital
Sendai, Miyagi, 980-0872
Jichi Medical University Hospital
Shimotsuke, Tochigi, 329-0498
Showa University Hospital
Shinagawa-Ku, Tokyo, 142-8666
Keio University Hospital
Shinjuku-Ku, Tokyo, 160-8582
Tokyo Women's Medical University Medical Center East
Shinjuku-Ku, Tokyo, 162-0054
Osaka University Hospital
Suita, Osaka, 565-0871
Osaka Medical College Hospital
Takatsuki, Osaka, 569-0801
Ehime University Hospital
Toon-shi, Ehime, 791-0204
Tottori Municipal Hospital
Tottori, 680-0873
Mie University Hospital
Tsu, Mie-ken, 514-8507
Tsukuba University Hospital
Tsukuba, Ibaraki, 305-8576
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505
Okinawa Prefectural Chubu Hospital
Uruma, Okinawa, 904-2293
Tochigi Cancer Center
Utsunomiya, Tochigi, 320-0834
Mie Prefectural General Medical Center
Yokkaichi, Mie-ken, 510-8561
Yokohama Municipal Citizen's Hospital
Yokohama, Kanagawa, 240-8555
Tottori University
Yonago, Tottori, 683-8504
University of Fukui Hospital
Yoshida, Fukui, 910-1104
South Korea5 sites
Gangnam Severance Hospital in Korea
Dogok, Seoul, 250
Asan Medical Center
P’ungnap-tong, Seoul, 138-736
Korea Cancer Center Hospital
Seoul, Gongneung-Dong, 139-706
Shinchon Severance Hospital
Seoul, Shinchon, 03722
Ewha Womans University Medical Center
Yangcheon, Seoul, 1071
Singapore2 sites
KK Women's and Children's Hospital
Bukit Timah, 229899
National University Hospital of Singapore
Kent Ridge, 119074
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, Pa 15213
New Zealand1 site
University of Otago - Christchurch/Christchurch Women's Hospital
Christchurch
About this study
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
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.
Read the 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.
- Being tested
- Paclitaxel(intravenous) + Carboplatin(intravenous), Paclitaxel(intravenous) + Carboplatin(intraperitoneal)
- Keywords
- Epithelial ovarian cancer, Fallopian tube cancer, peritoneal cancer, intraperitoneal therapy, Carboplatin, Paclitaxel
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel(intravenous) + Carboplatin(intravenous)Drug
Also called Paclitaxel(Sawai),(NK), Paraplatin(BMS), Carboplatin(SANDOZ)
Paclitaxel(intravenous) + Carboplatin(intravenous) Paclitaxel : 80mg/m2, IV infusion, Day1, 8, and 15 Carboplatin: AUC=6.0, IV infusion, Day1 A total of 6 to 8 cycles will be repeated.
Paclitaxel(intravenous) + Carboplatin(intraperitoneal)Drug
Also called Paclitaxel(Sawai),(NK), Paraplatin(BMS), Carboplatin(SANDOZ)
Paclitaxel(intravenous) + Carboplatin(intraperitoneal) Paclitaxel : 80mg/m2, IV infusion, Day1, 8, and 15 Carboplatin: AUC=6.0, IP injection, Day1 A total of 6 to 8 cycles will be repeated.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment: dd-TCiv therapy | Active comparator | Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IV infusion once every 3 weeks Receives: Drug: Paclitaxel(intravenous) + Carboplatin(intravenous) |
| Study treatment: dd-TCip therapy | Experimental | Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IP injection once every 3 weeks Receives: Drug: Paclitaxel(intravenous) + Carboplatin(intraperitoneal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS)
Measured: 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 outcomes (6)
Overall survival (OS)
Measured: 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)
Measured: 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
Measured: 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
Measured: After the last cycle of the protocol teatment
Quality of Life (QOL) assessments
Measured: baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment
Cost-utility analysis
Measured: baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startMay 2010
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 655 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Trial & Investigation Consortium
- Sponsor type
- Research network
- Collaborators
- Japanese Gynecologic Oncology Group
- Responsible party
- Sponsor
- Investigators
- Keiichi Fujiwara, MD, PhD, Study chair, Saitama Medical University International Medical Center Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506856
- Sponsor's protocol ID
- GOTIC-001/JGOG3019
- Other IDs
- UMIN000003670, jRCTs031180141
- Acronym
- iPocc
- Status last verified
- Sep 2022
- First submitted
- 20 Dec 2011
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bristow RE, Tomacruz RS, Armstrong DK, Trimble EL, Montz FJ. Survival effect of maximal cytoreductive surgery for advanced ovarian carcinoma during the platinum era: a meta-analysis. J Clin Oncol. 2002 Mar 1;20(5):1248-59. doi: 10.1200/JCO.2002.20.5.1248.
PubMed 11870167Neijt JP, Engelholm SA, Tuxen MK, Sorensen PG, Hansen M, Sessa C, de Swart CA, Hirsch FR, Lund B, van Houwelingen HC. Exploratory phase III study of paclitaxel and cisplatin versus paclitaxel and carboplatin in advanced ovarian cancer. J Clin Oncol. 2000 Sep;18(17):3084-92. doi: 10.1200/JCO.2000.18.17.3084.
PubMed 10963636Piccart MJ, Bertelsen K, James K, Cassidy J, Mangioni C, Simonsen E, Stuart G, Kaye S, Vergote I, Blom R, Grimshaw R, Atkinson RJ, Swenerton KD, Trope C, Nardi M, Kaern J, Tumolo S, Timmers P, Roy JA, Lhoas F, Lindvall B, Bacon M, Birt A, Andersen JE, Zee B, Paul J, Baron B, Pecorelli S. Randomized intergroup trial of cisplatin-paclitaxel versus cisplatin-cyclophosphamide in women with advanced epithelial ovarian cancer: three-year results. J Natl Cancer Inst. 2000 May 3;92(9):699-708. doi: 10.1093/jnci/92.9.699.
PubMed 10793106Ozols RF, Bundy BN, Greer BE, Fowler JM, Clarke-Pearson D, Burger RA, Mannel RS, DeGeest K, Hartenbach EM, Baergen R; Gynecologic Oncology Group. Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2003 Sep 1;21(17):3194-200. doi: 10.1200/JCO.2003.02.153. Epub 2003 Jul 14.
PubMed 12860964Katsumata N, Yasuda M, Takahashi F, Isonishi S, Jobo T, Aoki D, Tsuda H, Sugiyama T, Kodama S, Kimura E, Ochiai K, Noda K; Japanese Gynecologic Oncology Group. Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomised controlled trial. Lancet. 2009 Oct 17;374(9698):1331-8. doi: 10.1016/S0140-6736(09)61157-0. Epub 2009 Sep 18.
PubMed 19767092Alberts DS, Liu PY, Hannigan EV, O'Toole R, Williams SD, Young JA, Franklin EW, Clarke-Pearson DL, Malviya VK, DuBeshter B. Intraperitoneal cisplatin plus intravenous cyclophosphamide versus intravenous cisplatin plus intravenous cyclophosphamide for stage III ovarian cancer. N Engl J Med. 1996 Dec 26;335(26):1950-5. doi: 10.1056/NEJM199612263352603.
PubMed 8960474Markman M, Bundy BN, Alberts DS, Fowler JM, Clark-Pearson DL, Carson LF, Wadler S, Sickel J. Phase III trial of standard-dose intravenous cisplatin plus paclitaxel versus moderately high-dose carboplatin followed by intravenous paclitaxel and intraperitoneal cisplatin in small-volume stage III ovarian carcinoma: an intergroup study of the Gynecologic Oncology Group, Southwestern Oncology Group, and Eastern Cooperative Oncology Group. J Clin Oncol. 2001 Feb 15;19(4):1001-7. doi: 10.1200/JCO.2001.19.4.1001.
PubMed 11181662Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985.
PubMed 16394300Miyagi Y, Fujiwara K, Kigawa J, Itamochi H, Nagao S, Aotani E, Terakawa N, Kohno I; Sankai Gynecology Study Group (SGSG). Intraperitoneal carboplatin infusion may be a pharmacologically more reasonable route than intravenous administration as a systemic chemotherapy. A comparative pharmacokinetic analysis of platinum using a new mathematical model after intraperitoneal vs. intravenous infusion of carboplatin--a Sankai Gynecology Study Group (SGSG) study. Gynecol Oncol. 2005 Dec;99(3):591-6. doi: 10.1016/j.ygyno.2005.06.055. Epub 2005 Aug 10.
PubMed 16095677Fujiwara K, Armstrong D, Morgan M, Markman M. Principles and practice of intraperitoneal chemotherapy for ovarian cancer. Int J Gynecol Cancer. 2007 Jan-Feb;17(1):1-20. doi: 10.1111/j.1525-1438.2007.00809.x.
PubMed 17291226Demets DL. Futility approaches to interim monitoring by data monitoring committees. Clin Trials. 2006;3(6):522-9. doi: 10.1177/1740774506073115.
PubMed 17170036Huang HQ, Brady MF, Cella D, Fleming G. Validation and reduction of FACT/GOG-Ntx subscale for platinum/paclitaxel-induced neurologic symptoms: a gynecologic oncology group study. Int J Gynecol Cancer. 2007 Mar-Apr;17(2):387-93. doi: 10.1111/j.1525-1438.2007.00794.x.
PubMed 17362317Calvert AH, Newell DR, Gumbrell LA, O'Reilly S, Burnell M, Boxall FE, Siddik ZH, Judson IR, Gore ME, Wiltshaw E. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol. 1989 Nov;7(11):1748-56. doi: 10.1200/JCO.1989.7.11.1748.
PubMed 2681557
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01506856
- Acronym / sponsor ID
- iPocc / GOTIC-001/JGOG3019
- Keywords
- Epithelial ovarian cancer, Fallopian tube cancer, peritoneal cancer, intraperitoneal therapy, Carboplatin, Paclitaxel
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 655 participants (actual)
- Lead sponsor
- Gynecologic Oncology Trial & Investigation ConsortiumResearch network
- Collaborators
- Japanese Gynecologic Oncology Group
- Study start
- May 2010
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 10 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment: dd-TCiv therapy | Active comparator | Drug: Paclitaxel(intravenous) + Carboplatin(intravenous)Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IV infusion once every 3 weeks |
| Study treatment: dd-TCip therapy | Experimental | Drug: Paclitaxel(intravenous) + Carboplatin(intraperitoneal)Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IP injection once every 3 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel(intravenous) + Carboplatin(intravenous)Also: Paclitaxel(Sawai),(NK), Paraplatin(BMS), Carboplatin(SANDOZ)Paclitaxel(intravenous) + Carboplatin(intravenous) Paclitaxel : 80mg/m2, IV infusion, Day1, 8, and 15 Carboplatin: AUC=6.0, IV infusion, Day1 A total of 6 to 8 cycles will be repeated. | Drug | Standard treatment: dd-TCiv therapy |
| Paclitaxel(intravenous) + Carboplatin(intraperitoneal)Also: Paclitaxel(Sawai),(NK), Paraplatin(BMS), Carboplatin(SANDOZ)Paclitaxel(intravenous) + Carboplatin(intraperitoneal) Paclitaxel : 80mg/m2, IV infusion, Day1, 8, and 15 Carboplatin: AUC=6.0, IP injection, Day1 A total of 6 to 8 cycles will be repeated. | Drug | Study treatment: dd-TCip therapy |
Primary outcome
Progression-free survival(PFS)
Time frame: 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
6 secondary outcomes
Overall survival (OS)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: After the last cycle of the protocol teatment
Quality of Life (QOL) assessments
Time frame: baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment
Cost-utility analysis
Time frame: baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Background: PubMed 11870167Bristow RE, Tomacruz RS, Armstrong DK, Trimble EL, Montz FJ. Survival effect of maximal cytoreductive surgery for advanced ovarian carcinoma during the platinum era: a meta-analysis. J Clin Oncol. 2002 Mar 1;20(5):1248-59. doi: 10.1200/JCO.2002.20.5.1248.
- Background: PubMed 10963636Neijt JP, Engelholm SA, Tuxen MK, Sorensen PG, Hansen M, Sessa C, de Swart CA, Hirsch FR, Lund B, van Houwelingen HC. Exploratory phase III study of paclitaxel and cisplatin versus paclitaxel and carboplatin in advanced ovarian cancer. J Clin Oncol. 2000 Sep;18(17):3084-92. doi: 10.1200/JCO.2000.18.17.3084.
- Background: PubMed 10793106Piccart MJ, Bertelsen K, James K, Cassidy J, Mangioni C, Simonsen E, Stuart G, Kaye S, Vergote I, Blom R, Grimshaw R, Atkinson RJ, Swenerton KD, Trope C, Nardi M, Kaern J, Tumolo S, Timmers P, Roy JA, Lhoas F, Lindvall B, Bacon M, Birt A, Andersen JE, Zee B, Paul J, Baron B, Pecorelli S. Randomized intergroup trial of cisplatin-paclitaxel versus cisplatin-cyclophosphamide in women with advanced epithelial ovarian cancer: three-year results. J Natl Cancer Inst. 2000 May 3;92(9):699-708. doi: 10.1093/jnci/92.9.699.
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- Japanese Gynecologic Oncology GroupLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keiichi Fujiwara, MD, PhD study chair
Saitama Medical University International Medical Center Comprehensive Cancer Center
62 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Paclitaxel(intravenous) + Carboplatin(intravenous) and Paclitaxel(intravenous) + Carboplatin(intraperitoneal) in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Gynecologic Oncology Trial & Investigation Consortium at 62 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in Japan, South Korea, Singapore, United States, Hong Kong and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival(PFS) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01506856, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.