JGOG1079

JRCT ID: jRCTs051180157

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Stage IVB, recurrent or persistant cervical cancer
• Date of first enrollment: 06/03/2017
• Target sample size: 70
• Study type: Interventional

Intervention(s)

Paclitaxel 175mg/m2 day1
Carboplatin AUC=5 day1
Bevacizumab 15mg/kg day1
tri-weekly

Outcome(s)

• Primary Outcome: Progression Free Survival: PFS

Secondary Outcome

Overall Response Rate: ORR
Overall Survival: OS
Time to Treatment Failure: TTF
Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include 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.

Exclude criteria

1.Patient who has received any cheotherapy except for CCRT
2.Patients with a history of anti-VEGF and anti-VEGFR treatment
3.Patients with multiple cancers whose disease-free period is less than 5 years
4.Patient with perforation of the digestive tract and severe fistula within 6 months before registration
5.Patients with bilateral hydronephrosis that cannot be alleviated by ureteral stents or percutaneous drainage
6.Patients who have a high possibility of bleeding due to congenital hemorrhage or other factors
7.Patient suspected or diagnosed as arterial thromboembolism (cerebral infarction, myocardial infarction, etc.) at registration
8.Patients with metastases to the central nervous system
9. Patient with uncontrolled hypertension at registration 10,11,12 Patient with a history of hypersensitivity to the drug used in platinum preparations, combination to bevacizumab and Against drugs or other recombinant humanized antibodies derived from Chinese hamster ovary cells
13. Patients for whom invasive surgery has been or may be performed
14. Patients who are pregnant or nursing, patients who have a positive pregnancy test
15.Patients who have clinical symptoms or findings of intestinal obstruction and need instillation or central venous nutrition
16.CTCAE ver.4.03 Patients with a complication of peripheral neuropathy of Grade 3 or more
17.CTCAE ver. 4.03 Patients who have a merger of 2 or more Grade 2 blood clots or a history of less than 1 month prior to registration
18.Patient with active infection at registration
19.Patients who are positive for HIV antibody, HBs antigen, HCV antibody
20.Patient who is judged inappropriate to participate in this study by the attending physician

Related Information

• Primary Sponsor: TAKESHIMA Nobuhiro
• Source(s) of Monetary Support: Japanese Gynecologic Oncology Group
• Secondary ID(s): UMIN000026063