cervical intraepithelial neoplasia
Conditions
Sponsors
Murakami Hirotake
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Female patients over 20 years old when obtaining consent 2)The subjects were patients who were diagnosed with CIN2 or CIN3 based on cervical cytology and histology findings and whose lesions were confirmed macroscopically by colposcopy. 3) Patients who do not wish to receive treatment other than PDT including 4) Eastern Cooperative Oncology Group performance status; 0-1 5) Patients with adequate bone marrow function 1.White blood cell count ; >3,000/mm3 2.Platelet count ; >100,000/mm3 3.Both alanine aminotransferase and aspartate aminotransferase ; Less than twice the facility standard 4.Serum total bilirubin level ; <2.0 mg/dL 5.Blood urea nitrogen and serum creatinine; Less than 1.5 times the facility standard 6) Provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1) patients with AGC (atypical glandular cells), AIS (adenocarcinoma in situ), invasive squamous cell carcinoma or other cervical malignant tumor 2) patients diagnosed with UCF (Unsatisfactory colposcopic findings) or TZ type3 by colposcopy 3) patients with other cancer 4) significant cardiovascular diseases (uncontrolled hypertension, myocardial infarction, unstable angina, congestive heart failure), uncontrolled diabetes mellitus, or severe liver cirrhosis, severe renal failure 5) preexisting of sun photosensitivity 6) porphyria 7) history of treatment with PDT using porfimer sodium or talaporfin sodium 8) pregnant or nursed women, and woman want to pregnancy within this trial period 9) unwillingness to use of contraception 10) participating in other clinical trials or within 3 months after retirement of prior clinical trial 11) judged by investigator that enrollment was inappropriate for the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response | — |
Secondary
| Measure | Time frame |
|---|---|
| the clearance rate of HPV the clearance rate of HPV 12 weeks after PDT recurrence-free interval, recurrence rate overall survival preterm birth rate, threatened premature delivery rate, and changes in cervical length | — |
Contacts
Public ContactHirotake Murakami
Hamamatsu University Hospital
Outcome results
None listed