UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003682 |
|---|---|
| Receipt number | R000004462 |
| Scientific Title | A Phase III randomized controlled clinical trial of CARBOPLATIN and PACLITAXEL(OR GEMCITABINE) alone or in combination with BEVACIZUMAB (NSC #704865, IND #7921) followed by BEVACIZUMAB and secondary cytoredutive surgery in platinum sensitive, recurrent ovarian, peritoneal primary and fallopian tube cancer. |
| Date of disclosure of the study information | 2010/06/01 |
| Last modified on | 2024/09/29 18:55:59 |
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Basic information
Public title
A Phase III randomized controlled clinical trial of CARBOPLATIN and PACLITAXEL(OR GEMCITABINE) alone or in combination with BEVACIZUMAB (NSC #704865, IND #7921) followed by BEVACIZUMAB and secondary cytoredutive surgery in platinum sensitive, recurrent ovarian, peritoneal primary and fallopian tube cancer.
Acronym
GOG-0213
Scientific Title
A Phase III randomized controlled clinical trial of CARBOPLATIN and PACLITAXEL(OR GEMCITABINE) alone or in combination with BEVACIZUMAB (NSC #704865, IND #7921) followed by BEVACIZUMAB and secondary cytoredutive surgery in platinum sensitive, recurrent ovarian, peritoneal primary and fallopian tube cancer.
Scientific Title:Acronym
GOG-0213
Region
| Japan | Asia(except Japan) | North America |
Condition
Condition
PLATINUM-SENSITIVE, RECURRENT OVARIAN, PERITONEAL PRIMARY AND FALLOPIAN TUBE CANCER
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1)To determine if surgical secondary cytoreduction in addition to adjuvant chemotherapy increases the duration of overall survival in patients with recurrent platinum sensitive epithelial ovarian cancer, peritoneal primary or Fallopian tube cancer.
2)To determine if the addition of bevacizumab to the second-line and maintenance phases of treatment increases the duration of overall survival relative to secondline paclitaxel and carboplatin alone in patients with recurrent platinum sensitive epithelial ovarian cancer, peritoneal primary or Fallopian tube cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Overall Survival
Key secondary outcomes
Progression-Free Survival, Adverse Event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
8
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Paclitaxel(175mg/m2) day1 + Carboplatin(AUC5) day1 q21days 6-8cycles
Interventions/Control_2
Paclitaxel(175mg/m2) day1 + Carboplatin(AUC5) day1 + Bevacizumab(15mg/kg) day1 q21days 6-8cycles, followed by Bevacizumab(15mg/kg) q21days until progression
Interventions/Control_3
Cytoreductive surgery, then, Paclitaxel(175mg/m2) day1 + Carboplatin(AUC5) day1 q21days 6-8cycles, then, Bevacizumab(15mg/kg) q21days
Interventions/Control_4
Cytoreductive surgery, then, Paclitaxel(175mg/m2) day1 + Carboplatin(AUC5) day1 + Bevacizumab(15mg/kg) day1 q21days 6-8cycles, followed by Bevacizumab(15mg/kg) q21days until progression
Interventions/Control_5
Gemcitabine 1000mg/m2 d1 & d8+ Carboplatin AUC 4 day 1 q21days 6-8cycles
Interventions/Control_6
Gemcitabine 1000mg/m2 d1 & d8+ Carboplatin AUC 4 day 1 + Bevacizumab(15mg/kg) day1 q21days 6-8cycles, followed by Bevacizumab(15mg/kg) q21days until progression
Interventions/Control_7
Cytoreductive surgery, then, Gemcitabine 1000mg/m2 d1 & d8+ Carboplatin AUC 4 day 1 q21days 6-8cycles
Interventions/Control_8
Cytoreductive surgery, then, Gemcitabine 1000mg/m2 d1 & d8+ Carboplatin AUC 4 day 1 q21days 6-8cycles , then, Bevacizumab(15mg/kg) q21days
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1)Patients enrolled after August 28, 2011 must be candidates for cytoreductive surgery and consent to have their surgical treatment determined by randomization.
2)Patients must have histologic diagnosis of epithelial ovarian carcinoma, peritoneal primary or Fallopian tube carcinoma, which is now recurrent.
3)Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous denocarcinoma,
undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified.
4)Patients must have had a complete response to front-line platinum-taxane therapy (at least 3 cycles).
5)Patients must have recurrence documented by clinically evident measurable recurrent disease.
6)ANC greater than or equal to 1,500/mm3
7)PLT greater than or equal to 100,000/mm3.
8)Creatinine(non-IDMS) less than or equal to 1.5 x institutional upper limit normal(ULN),CTCAE G1
9)Total bilirubin less than or equal to 1.5 x ULN
10)SGOT/AST and ALP less than or equal to 2.5 times the upper limit of normal in the absence of liver metastasis. SGOT/AST and ALP <5.0 times ULN in the presence of liver metastasis.
11)UPCR < 1.0mg/dL.
12) (This eligibility criterion does not apply to patients enrolled after August 7,
2011).Patients who are not candidates for surgical cytoreduction are eligible for the chemotherapy randomization. Patients are not considered candidates for surgical cytoreduction if complete cytoreduction in the estimation of the investigator is impossible or a medical infirmity precludes exploration and debulking.
13)Patients must have met the pre-entry requirements specified in protocol Section 7.0.
14)Patients must have signed an approved informed consent and authorization permitting release of personal health information.
15)GOG PS: 0-2
16)Age: 18 or older
Key exclusion criteria
1)More than 1 previous regimen of chemo
2)Receiving concurrent immunotherapy or radiotherapy
3)Prior radiotherapy to any portion of the abdominal cavity or pelvis
4)Evidence of partial bowel obstruction or perforation
5)Prior chemo for any abdominal or pelvic tumor
6)Synchronous primary endometrial cancer, or a past history of primary endometrial cancer
7)Secondary cytoreduction for recurrent disease
8)Uncontrolled infection
9)Concurrent severe medical problems unrelated to the malignancy
10)More than grade2 peripheral neuropathy
11)History of allergic reactions to carboplatin and/or paclitaxel or chemically similar compounds.
12)Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
13)Childbearing potential, not practicing adequate contraception, pregnant or nursing
14)Other invasive malignancies, with the exception of non-melanoma skin cancer, within the last 5 yrs
15)Active bleeding or pathologic conditions that carry high risk of bleeding
16)History or evidence upon physical examination of CNS disease
17)Significant cardiac conduction abnormalities
18)Uncontrolled hypertension, defined as systolic >150mmHg or diastolic >90mmHg
19)Myocardial infarction, cardiac arrhythmia or unstable angina < 6mo prior to registration
20)NYHA Grade2 or greater congestive heart failure
21)Serious cardiac arrhythmia requiring medication
22)Grade2 or greater peripheral vascular disease
23)History of CVA within 6mo
24)Patients who have had a major surgical procedure, open biopsy, dental extractions or other dental surgery/procedure that results in an open wound, or significant traumatic injury within 28days prior to the treatment on this study, or anticipation of need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within 7days prior to the treatment on this study.
Target sample size
1050
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Robert L. Coleman, M.D. |
Organization
UT MD Anderson Cancer Center
Division name
Department of Gynecologic Oncology
Zip code
Address
P.O. Box 301439, Houston TX 77230 1439
TEL
716-845-5702
support@gogstats.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichi Fujiwara, MD.,PhD |
Organization
Saitama Medical University International Medical Center
Division name
Department of Gynecologic Oncology
Zip code
Address
1397-1, Yamane, HIdaka-city, Saitama
TEL
042-984-4111
Homepage URL
http://www.gog.org
nrg-japan@newkast.or.jp
Sponsor or person
Institute
Gynecologic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Gynecologic Oncology Group
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT00565851
Org. issuing International ID_1
National Cancer Institute (NCI)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
埼玉医科大学国際医療センター（埼玉県）、鳥取大学医学部附属病院（鳥取県）、東京慈恵会医科大学附属病院（東京都）、鹿児島市立病院（鹿児島県）、近畿大学医学部附属病院（大阪府）、国立がん研究センター中央病院（東京都）、四国がんセンター（愛媛県）、東北大学病院（宮城県）、北海道大学病院（北海道）、岩手医科大学附属病院（岩手県）、広島大学病院（広島県）、新潟大学医歯学総合病院（新潟県）、慶應義塾大学病院（東京）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2009 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004462
