Patients with radioresistant cervical cancer after radiotherapy with or without chemotherapy, or for local recurrence of vagina stump after radiotherapy
Conditions
Interventions
The newly developed laser thermotherapy equipment 1. Thermotherapy is one time a week. 2. Heating time is from 40 to 50 minutes at 43-45 degrees. 3. Thermotherapy is done 5 or 6 times.
Sponsors
Nagoya University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1)A patient with superficial lesion and a little tumor amount. (2)A patient with no recurrent lesion except for recurrence of uterine cervix in pelvis, or a patients with an expected survival of more than 6 months after this treatment. (3)A patient without distant metastasis. (4))A patient with difficulty of additional radiation therapy. (5)A patient with difficulty of operation or with refusal of operation. (6)A patient without indication of chemotherapy or with refusal of chemotherapy. (7)A patient who has been diagnosed with recurrent or residual cancer of the uterine cervix based on histology (biopsy). (8)A patient who has squamous cell carcinoma, adenosquamous cell carcinoma, or adenocarcinoma is limited. (9)A patient with an expected survival of more than 6 months. (10)A female patient aged 20 years or older at the time of enrollment and a patient who has provided written informed consent to partcipate in this study.
Exclusion criteria
Exclusion criteria: (1)A patient who cannot be inserted this equipment through the vagina and can be hard to attain to a lesion. (2)A patient with collagen disease. (3)A patient with active double cancer. (4)A patient whom the investigator considers to be ineligible as a subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of safety -Measured by incidence of adverse events before, in and after treatment and until 6 months after the treatment. | — |
Countries
Japan
Contacts
Public ContactYoshiyuki Itoh
Nagoya University Hospital Dept. of Radiology
Outcome results
None listed