Uterine cervical cancer
Conditions
Interventions
Patients receive radiotherapy and intravenous administration of CPT-11 and CDDP once a week, simultaneously. Traetment repeats weekly for 5 courses in the absence of unacceptable toxicity.
Sponsors
Kansai Clinical Oncology Group (KCOG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed primary uterine cervical cancer. 2) Clinical stage III to IVa and IVb by para-aortic lymphnode metastasis. 3) Disease with measurable lesion according to RECIST. 4) ECOG Performance Status 0-1. 5) No prior chemothrapy and radiotherapy. 6) Adequate bone marrow, cardiac, liver, lung, kidney functions. a) WBC> 3,000/mm3, 10.0g/dl, c) Platelets > 100,000/mm3, d) T-Bil normal lower limits, j) PaO2> 60torr, k) ECG normal. 7) Expected survival more than 3months. 8) Fully written informed consent.
Exclusion criteria
Exclusion criteria: 1) Severe complications: a) infections, diarrhea (watery), ileus, interstistial pneumonitis, lung fibrosis, b) massive pleural effusion or ascites, c) uncontrollable diabetes mellitus, d) other complications which suffer from progressing study. 2) Co-existence of active other malignancies. 3) The patients with prior radiotherapy whose treatment area of irradiation will be overlaid to ex-treatment area. 4) Pregnant or expected to be pregnant and breast feeding mother. 5) Known severe hypersensitivity to agent. 6) Whom the investigator think unappropriate as a candidate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events Feasibility Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival Overall survival | — |
Countries
Japan
Contacts
Public ContactKimihiko Ito
Kansai Rosai Hospital Obstetrics and Gynecology
Outcome results
None listed