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Clinical Trials/JPRN-jRCTs031180165
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.

Registry
who.int
Start Date
February 27, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Imai Yuichi

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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