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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01506856




Registration number
NCT01506856
Ethics application status
Date submitted
20/12/2011
Date registered
10/01/2012
Date last updated
15/09/2023

Titles & IDs
Public title
Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial
Scientific 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
Secondary ID [1] 0 0
UMIN000003670
Secondary ID [2] 0 0
GOTIC-001/JGOG3019
Universal Trial Number (UTN)
Trial acronym
iPocc
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epithelial Ovarian Cancer 0 0
Fallopian Tube Cancer 0 0
Primary Peritoneal Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Paclitaxel(intravenous) + Carboplatin(intravenous)
Treatment: Drugs - Paclitaxel(intravenous) + Carboplatin(intraperitoneal)

Active Comparator: Standard treatment: dd-TCiv therapy - Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IV infusion once every 3 weeks

Experimental: Study treatment: dd-TCip therapy - Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IP injection once every 3 weeks


Treatment: Drugs: Paclitaxel(intravenous) + Carboplatin(intravenous)
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.

Treatment: Drugs: Paclitaxel(intravenous) + Carboplatin(intraperitoneal)
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival(PFS)
Timepoint [1] 0 0
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 [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Tumor response (only patients with evaluable disease)
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Adverse events
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Treatment completion rate
Timepoint [4] 0 0
After the last cycle of the protocol teatment
Secondary outcome [5] 0 0
Quality of Life (QOL) assessments
Timepoint [5] 0 0
baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment
Secondary outcome [6] 0 0
Cost-utility analysis
Timepoint [6] 0 0
baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment

Eligibility
Key inclusion criteria
1. Patients assumed to have a stageII-IV epithelial ovarian, fallopian tube, or primary
peritoneal cancer as a pre-surgery diagnosis

2. 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.)

3. ECOG Performance Status: 0-2

4. Patients who provide consent for placement of the IP port system, if randomized to
Regimen II (Study treatment: dd-TCip therapy)

5. Patients expected to receive the first protocol treatment within 8 weeks after the
comprehensive staging surgery

6. 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)

7. Patients expected to survive longer than 3 months from the start date of the protocol
treatment

8. Patients aged 20 years and older at the time of tentative registration (with no upper
age limit)

9. Patients who provide written informed consent for participation in this trial
Minimum age
20 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients assumed to have a borderline malignancy of the ovary, fallopian tube, or
primary peritoneal cancer

2. Patients who have received previous chemotherapy or radiation therapy to treat the
current disease

3. 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)

4. 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

5. Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated
castor oil

6. Patients with a pleural effusion requiring continuous drainage

7. Patients with an active infection requiring antibiotics

8. Patients who are pregnant, nursing or of child-bearing potential

9. Patients with evidence upon physical examination of brain tumor and any brain
metastases

10. Patients for whom completion of this study and/or follow-up is deemed inappropriate
for any reason

11. Patients with any signs/symptoms of interstitial pneumonia

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/02/2021
Sample size
Target
Accrual to date
Final
655
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania
Country [2] 0 0
Hong Kong
State/province [2] 0 0
High West
Country [3] 0 0
Japan
State/province [3] 0 0
Aichi
Country [4] 0 0
Japan
State/province [4] 0 0
Aomori
Country [5] 0 0
Japan
State/province [5] 0 0
Chiba
Country [6] 0 0
Japan
State/province [6] 0 0
Ehime
Country [7] 0 0
Japan
State/province [7] 0 0
Fukui
Country [8] 0 0
Japan
State/province [8] 0 0
Gunma
Country [9] 0 0
Japan
State/province [9] 0 0
Hiroshima
Country [10] 0 0
Japan
State/province [10] 0 0
Hyogo
Country [11] 0 0
Japan
State/province [11] 0 0
Ibaraki
Country [12] 0 0
Japan
State/province [12] 0 0
Iwate
Country [13] 0 0
Japan
State/province [13] 0 0
Kanagawa
Country [14] 0 0
Japan
State/province [14] 0 0
Mie
Country [15] 0 0
Japan
State/province [15] 0 0
Miyagi
Country [16] 0 0
Japan
State/province [16] 0 0
Nagano
Country [17] 0 0
Japan
State/province [17] 0 0
Nara
Country [18] 0 0
Japan
State/province [18] 0 0
Okinawa
Country [19] 0 0
Japan
State/province [19] 0 0
Osaka
Country [20] 0 0
Japan
State/province [20] 0 0
Saitama
Country [21] 0 0
Japan
State/province [21] 0 0
Shizuoka
Country [22] 0 0
Japan
State/province [22] 0 0
Tochigi
Country [23] 0 0
Japan
State/province [23] 0 0
Tokyo
Country [24] 0 0
Japan
State/province [24] 0 0
Tottori
Country [25] 0 0
Japan
State/province [25] 0 0
Yamaguchi
Country [26] 0 0
Japan
State/province [26] 0 0
Fukuoka
Country [27] 0 0
Japan
State/province [27] 0 0
Kagoshima
Country [28] 0 0
Japan
State/province [28] 0 0
Kyoto
Country [29] 0 0
Japan
State/province [29] 0 0
Nagasaki
Country [30] 0 0
Japan
State/province [30] 0 0
Niigata
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Gongneung-Dong
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Seoul
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Shinchon
Country [34] 0 0
New Zealand
State/province [34] 0 0
Christchurch
Country [35] 0 0
Singapore
State/province [35] 0 0
Bukit Timah
Country [36] 0 0
Singapore
State/province [36] 0 0
Kent Ridge

Funding & Sponsors
Primary sponsor type
Other
Name
Gynecologic Oncology Trial & Investigation Consortium
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Japanese Gynecologic Oncology Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01506856
Trial related presentations / 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.
Neijt 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.
Piccart 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.
Ozols 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.
Katsumata 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.
Alberts 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.
Markman 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.
Armstrong 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.
Miyagi 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.
Fujiwara 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.
Demets DL. Futility approaches to interim monitoring by data monitoring committees. Clin Trials. 2006;3(6):522-9. doi: 10.1177/1740774506073115.
Huang 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.
Calvert 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.
Public notes

Contacts
Principal investigator
Name 0 0
Keiichi Fujiwara, MD, PhD
Address 0 0
Saitama Medical University International Medical Center Comprehensive Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01506856