JPRN-jRCTs031180165
Recruiting
Phase 2
Concurrent paclitaxel and carboplatin-based chemoradiotherapy for stage III or IVA cervical cancer with renal dysfunction
Imai Yuichi0 sites32 target enrollmentFebruary 27, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Imai Yuichi
- Enrollment
- 32
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age 20 years or older.
- •2\. Patient must have been pathologically diagnosed with squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix.
- •3\. Patients must have clinical stage III to IVA disease.
- •4\. Patients must have renal dysfunction (less than 60 ml/min of eGFR).
- •5\. Patients must not have previously received radiation therapy, chemotherapy or surgery for the current disease.
- •6\. ECOG performance status must be 0 or 1\.
- •7\. Patients must have adequate organ functions except renal function.
- •8\. Patients must have provided written informed consent.
Exclusion Criteria
- •1\. Patients with vaginal stump cancer.
- •2\. Patients with active infectious disease.
- •3\. Patients with severe complications: for example, uncontrolled hypertension, diabetes, active bleeding or collagen disease for which steroid therapy is required.
- •4\. Patients who have received radiation therapy at the pelvis.
- •5\. Patients who have received chemotherapy with paclitaxel or carboplatin.
- •6\. Patients with any active concurrent malignancies.
- •7\. Patients who need hemodialysis or peritoneal dialysis continuously.
- •8\. Patients who are pregnant, may become pregnant, or hope to become pregnant.
- •9\. Patients who are breast\-feeding.
- •10\. Patients considered to be inappropriate for any reason by their attending physicians.
Outcomes
Primary Outcomes
Not specified
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