Locally advanced uterine cervical cancer
Conditions
Interventions
Carbon ion radiotherapy Image-guided brachytherapy Chemotherapy (Cisplatin)
Sponsors
Gunma University Heavy Ion Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically diagnosed adenocarcinoma, adeno-squamous cell carcinoma, or squamous cell carcinoma of uterine cervix. 2) FIGO Stage II (larger than or equal to 4 cm), III, or IV. 3) No para-aortic lymph node with the smaller diameter equal to or larger than 1 cm is observed in CT within 4 weeks before registration. 4) Measurable tumors on CT or MRI. 5) Age >=20 <=75. 6) Performance status 0-2. 7) No prior history of surgery or chemotherapy for uterine cervical cancer. 8) No abnormality in major organ functions. 9) Expected life expectancy of more than 6 months. 10) Informed consent is obtained.
Exclusion criteria
Exclusion criteria: 1) Tumor invasion to gastro-intestinal tract. 2) Past history of chemotherapy. 3) Past history of radiotherapy in pelvis. 4) Uncontrolled infection in pelvis. 5) Severe concomitant diseases. 6) Active concurrent cancers. 7) (Possibly) pregnant patients. 8) Other medically or psychologically unsuitable circumstances are present.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Incidence of dose-limiting toxicity. 2) Incidence rate of acute adverse effects (within 90 days after the start of treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Primary response in pelvis. 2) Incidence rate of late adverse effect (after 90 days from the start of treatment). | — |
Countries
Japan
Contacts
Public ContactTatsuya Ohno
Gunma University Gunma University Heavy Ion Medical Research Center
Outcome results
None listed