UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011154 |
|---|---|
| Receipt number | R000013058 |
| Scientific Title | A PHASE III RANDOMIZED TRIAL OF PULSE ACTINOMYCIN-D VERSUS MULTI-DAY METHOTREXATE FOR THE TREATMENT OF LOW-RISK GESTATIONAL TROPHOBLASTIC NEOPLASIA |
| Date of disclosure of the study information | 2013/07/16 |
| Last modified on | 2024/09/29 18:56:33 |
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Basic information
Public title
A PHASE III RANDOMIZED TRIAL OF PULSE ACTINOMYCIN-D VERSUS MULTI-DAY METHOTREXATE FOR THE TREATMENT OF LOW-RISK GESTATIONAL TROPHOBLASTIC NEOPLASIA
Acronym
GOG-0275
Scientific Title
A PHASE III RANDOMIZED TRIAL OF PULSE ACTINOMYCIN-D VERSUS MULTI-DAY METHOTREXATE FOR THE TREATMENT OF LOW-RISK GESTATIONAL TROPHOBLASTIC NEOPLASIA
Scientific Title:Acronym
GOG-0275
Region
| Japan | North America |
Condition
Condition
LOW-RISK GESTATIONAL TROPHOBLASTIC NEOPLASIA
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that treatment with multi-day methotrexate is inferior to treatment with pulse actinomycin-D in patients with low-risk gestational trophoblastic disease with respect to complete response
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete response vs treatment failure
Key secondary outcomes
Severity of adverse events, W.H.O. risk score, choriocarcinoma histology, uterine artery pulsatility index
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
IV pulse actinomycin-D (1.25mg/m2) every 14 days. (2mg max dose)
Interventions/Control_2
IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose)
Interventions/Control_3
IM methotrexate (50mg) on Days 1, 3, 5, 7
(4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
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 who meet F.I.G.O. Stage I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN): post molar GTN or choriocarcinoma.
2)W.H.O. risk score 0-6 (See Appendix II-W.H.O. Risk Scoring Criteria).
3)Patients must be willing to practice effective contraception for the duration of the study.
4)Patients must have normal hepatic, hematologic, and renal function:
WBC >-; 3,000 cells/mcl;
Granulocytes >-; 1500/mcl;
Platelets >-; 100,000/mcl;
Creatinine <-; 2.0 mg/dcl; Bilirubin <-; 1.5x institutional normal;
ALT, AST and alkaline phosphatase <-; 3x institutional normal.
5)Patients must have signed an approved informed consent and authorization permitting release of personal health information.
6)Patients must be 18 years of age and older.
Key exclusion criteria
1)Patients who do not have GTN as defined in Key inclusion criteria 1).
2)Patients with non-gestational choriocarcinoma.
3)Patients who have previously been treated with cytotoxic chemotherapy. However, patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study.
4)Patients who have received prior pelvic radiation.
5)Patients with placental site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT).
6)Patients with GOG Performance status of 3 or 4.
7)Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
8)Patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up.
9)Patients who wish to breast-feed during treatment.
Target sample size
384
Research contact person
Name of lead principal investigator
| 1st name | JULIAN C. |
| Middle name | |
| Last name | SCHINK, M.D |
Organization
SPECTRUM MEDICAL GROUP
Division name
Gynecologic Oncology
Zip code
9999999
Address
648 MONROE AVE NW, SUITE 115 GRAND RAPIDS, MI 49503
TEL
616-267-7095
julian.schink@spectrumhealth.org
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Sato, M.D.,Ph.D. |
Organization
Tottori University, School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
683-8504
Address
36-1 Nishicho, Yonago-City, Tottori
TEL
085-938-6647
Homepage URL
http://www.gog.org
sshinya@med.tottori-u.ac.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
USA
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tottori University Hospital IRB #2
Address
36-1, Nishi-cho, Yonago, Tottori
Tel
0859-38-7021
cert.office@ml.med.tottori-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01535053
Org. issuing International ID_1
National Cancer Institute (NCI)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
鹿児島市立病院（鹿児島県）、鳥取大学医学部附属病院（鳥取県）、埼玉医科大学国際医療センター（埼玉県）、近畿大学医学部附属病院（大阪府）、東北大学病院（宮城県）、北海道大学病院（北海道）、呉医療センター・中国がんセンター（広島県）、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）、琉球大学医学部付属病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 16 | Day |
Related information
URL releasing protocol
https://clinicaltrials.gov/ct2/show/NCT01535053?term=GOG-0275&draw=2&rank=1
Publication of results
Published
Result
URL related to results and publications
Schink JC, et al. Gynecol Oncol 2020; 158(2): 354-360
Number of participants that the trial has enrolled
6
Results
Schink JC, et al. Gynecol Oncol 2020; 158(2): 354-360
Results date posted
| 2020 | Year | 09 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 08 | Month | 18 | Day |
Baseline Characteristics
Schink JC, et al. Gynecol Oncol 2020; 158(2): 354-360
Participant flow
Schink JC, et al. Gynecol Oncol 2020; 158(2): 354-360
Adverse events
Schink JC, et al. Gynecol Oncol 2020; 158(2): 354-360
Outcome measures
Schink JC, et al. Gynecol Oncol 2020; 158(2): 354-360
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 06 | 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
| 2013 | Year | 07 | Month | 09 | 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=R000013058
