jRCT1041250152
Recruiting
Not Applicable
A multicenter prospective study to explore safety and efficacy of drug therapy for recurrent cervical cancer with prior platinum chemotherapy
Not provided0 sites300 target enrollmentStarted: TBD
ConditionsRecurrent cervical cancer.
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 300
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
Eligibility Criteria
- Ages
- 18age old over to No limit (—)
- Sex
- Female
Inclusion Criteria
- •Recurrent cervical cancer with a history of plati num-based systemic chemotherapy (cisplatin used in CCRT is not included in systemic chemotherapy).
- •Previously administered platinum-based systemic chemotherapy must be one line. Postoperative adjuvant chemotherapy is one line, and a history of immune checkpoint inhibitors is not required.
- •The histological subtype is epithelial malignant tumor.
- •Age 18 years or older at the time of registration.
- •Performance status (PS) is 0 or 1 according to ECOG criteria.
- •Patients with measurable lesions.
- •No brain metastasis or meningeal metastasis accompanied by central nervous system symptoms.
- •None of the following I to IV regarding the period since previous treatment apply.
- •I. If prior chemoradiotherapy was administered, the last radiation was exposed within 42 days.
- •II. If radiation therapy (including palliative radiation therapy) was administered as prior treatment, it must be less than 14 days since the last radiation therapy.
Exclusion Criteria
- •Active double cancers (synchronous double cancers/multiple cancers and metachronous double cancers/multiple cancers with a disease-free interval of less than two years that require treatment).
- •Infection requiring systemic treatment.
- •Have a fever of 38.0 degrees Celsius or higher at the time of registration.
- •Are pregnant, possibly pregnant, within 28 days of giving birth, or breastfeeding.
- •Patients who have psychiatric disorders or symptoms that interfere with daily life and are judged to have difficulty participating in the study.
- •A history of severe drug hypersensitivity.
- •Paclitaxel, carboplatin, and cisplatin are contraindicated.
- •Receiving systemic (oral or intravenous) administration of steroids or other immunosuppressants.
- •Have diabetes mellitus treated with continuous insulin use or uncontrolled diabetes mellitus.
- •Have uncontrolled hypertension.
Investigators
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