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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000026063 |
Receipt No. | R000029934 |
Scientific Title | A phase II study for the efficacy of bevacizumab with paclitaxel and carboplatin in patient with stage IVB, recurrent or persistant cervical cancer. |
Date of disclosure of the study information | 2017/02/10 |
Last modified on | 2019/02/11 |
Basic information | ||
Public title | A phase II study for the efficacy of bevacizumab with paclitaxel and carboplatin in patient with stage IVB, recurrent or persistant cervical cancer. | |
Acronym | JGOG1079 | |
Scientific Title | A phase II study for the efficacy of bevacizumab with paclitaxel and carboplatin in patient with stage IVB, recurrent or persistant cervical cancer. | |
Scientific Title:Acronym | JGOG1079 | |
Region |
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Condition | |||
Condition | Stage IVB, recurrent or persistant cervical cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the clinical benefit of Bevacizumab treatment in combination with chemotherapy of Paclitaxel plus Carboplatin for patients with Stage IVB, recurrent or persistant cervical cancer as measured by the investigator assessed progression free survival(PFS). |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Progression Free Survival: PFS |
Key secondary outcomes | Overall Response Rate: ORR
Overall Survival: OS Time to Treatment Failure: TTF Safety |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Paclitaxel 175mg/m2 day1
Carboplatin AUC=5 day1 Bevacizumab 15mg/kg day1 tri-weekly |
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Interventions/Control_2 | ||
Interventions/Control_3 | ||
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Interventions/Control_5 | ||
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Interventions/Control_7 | ||
Interventions/Control_8 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | 1.Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.
2.More than 20 years old 3.ECOG Performance Status: 0-2 4.Life expectancy of >= 90 days 5.Histologically confirmed cervical cancer by histopathologic examination of uterine cervix 6.Patients with a diagnosis of confirmed cervical cancer such as squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma 7.Patients can be included if they have measurable diseases. 8.Adequate following organ function. |
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Key exclusion criteria | 1.Patient who has received any cheotherapy except for CCRT
2.Patient with perforation of the digestive tract and severe fistula within 6 months before registration 3.Patient with a history of hypersensitivity to the drug used in combination to bevacizumab 4.Patient with active infection at registration 5. Patient with uncontrolled hypertension at registration 6.Patient suspected or diagnosed as arterial thromboembolism (cerebral infarction, myocardial infarction, etc.) at registration 7.Patient who is judged inappropriate to participate in this study by the attending physician |
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Target sample size | 70 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Cancer Institute Hospital | ||||||
Division name | Department of Gynecology | ||||||
Zip code | |||||||
Address | 3-8-31, Ariake, Koutou-ku,Tokyo, 135-8550 Japan | ||||||
TEL | 03-3520-0111 | ||||||
nobuhiro.takeshima@jfcr.or.jp |
Public contact | |||||||
Name of contact person |
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Organization | Cancer Institute Hospital | ||||||
Division name | Department of Gynecology | ||||||
Zip code | |||||||
Address | 3-8-31, Ariake, Koutou-ku,Tokyo, 135-8550 Japan | ||||||
TEL | 03-3520-0111 | ||||||
Homepage URL | |||||||
maki.matsumura@jfcr.or.jp |
Sponsor | |
Institute | Japan Gynecologic Oncology Group:JGOG |
Institute | |
Department |
Funding Source | |
Organization | Japan Gynecologic Oncology Group:JGOG |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
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Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029934 |
Research Plan | |
Registered date | File name |
2018/02/10 | JGOG1079_Protcol_Ver.1.1.pdf |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |