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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031180165
Enrollment
32
Registered
2019-02-27
Start date
2017-07-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical cancer Cervical cancer

Interventions

Concurrent chemoradiotherapy

Sponsors

Imai Yuichi
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Discontinuance rate (defined as the rate of patients which are unable to continue the protocol therapy for any adverse events)

Secondary

MeasureTime frame
1.PFS 2.Completion rate (defined as the rate of performed chemo or radiation dosage prescribed in protocol within 8 weeks) 3.Overall response rate to the protocol therapy

Contacts

Public ContactYuichi Imai

Yokohama City University Hospital

you11sep@yokohama-cu.ac.jp+81-45-787-2800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026