Concurrent paclitaxel and carboplatin-based chemoradiotherapy for stage III or IVA cervical cancer with renal dysfunctio

Phase 2

Recruiting

• Conditions: Cervical cancer

• Registration Number: JPRN-jRCTs031180165
• Lead Sponsor: Imai Yuichi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 32

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified