Locally advanced adenocarcinoma of the uterine
Conditions
Interventions
1) Carbon-ion Radiotherapy
3.0Gy (RBE) per day, A dose of 36.0Gy (RBE) / 12 fractions 4.8Gy (RBE) per day, A dose of 38.4Gy (RBE) / 8 fractions A total dose of 74.4Gy (RBE) / 20 fractions 2) Carbon-ion Radiotherapy intraca
3.0Gy (RBE) per day, A dose of 36.0Gy (RBE) / 12 fractions 4.8Gy (RBE) per day, A dose of 38.4Gy (RBE) / 4 fractions A total dose of 55.2Gy (RBE) / 16 fractions Intracavitary irradiation
5.5Gy per day, A total dose of 16.5Gy (EQD2
21.3Gy10) / 3 fractions Chemotherapy
cisplatin (40mg / m2 / week) for 5 weeks
Sponsors
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: In common with carbon-ion radiotherapy simultaneous combination arm and the Carbon-ion radiotherapy single arm, all the following items shall be satisfied 1) Diagnosed as adeno-squamous cell carcinoma or adenocarcinoma of uterine cervix by cytology or histpathology 2) International Federation of Gynecology and Obstetrics (FIGO, 2008) stage IIB, III, IVA disease 3) No para-aortic lymph nodes >= within 4 weeks before registration 1 cm in minimum diameter on CT images 4) Without obvious organ metastasis by diagnostic imaging 5) Aged 20 or above at the time of registration 6) 0 to 2 of performance status (ECOG) 7) Patients with unresectable cases due to lesion status, age, complications or deny the resection 8) Patients who has no pretreatment history of chemical therapy and operation for cervical cancer 9) Patients who is ineligible for other clinical trials including Advanced Medicine Program B (Sen-shin Iryo B) 10) Written consent obtained for the participation in this study In addition to the above criteria, the following conditions are all satisfied for the arm to be used simultaneously with carbon-ion irradiation chemotherapy simultaneous combination. All the laboratory date are measured within 8 days before trial registration 1) Aged 75 or less at the time of registration 2) White blood cells >= 3,500 /mm3 3) Hemoglobin >= 9.0 g/dl 4) Platelet >= 100,000 /mm3 5) Albumin >= 3.0 g/dl 6) Total bilirubin =< 2 mg/dl 7) GOT(AST) =< 100 IU 8) Serum creatinine =< 1.5 mg/dl 9) Creatinine clearance >= 60 ml/min (Cockcroft & Gault equation)
Exclusion criteria
Exclusion criteria: 1) Severe complication such as severe heart disease, high blood pressure, diabetes, intractable infections, acute peptic ulcer, severe psychiatric disease 2) Active double cancer including concurrent or metachronous tumor within five years, except for lesion equivalent to carcinoma in situ or intramucosal cancer which is completely treated by local therapeutic procedure 3) Patients with tumor directly infected rectum 4) Previous history of radiotherapy for targeted lesion 5) Conditions that attending physicians consider unsuitable for this clinical study due to medical or psychological issues
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse free survival at 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Local control survival 2) Local response rate 3) Adverse event rate 4) Overall survival | — |
Countries
Japan
Contacts
Public ContactDr. Daisaku Yoshida
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization Ion-beam Radiation Oncology Center
Outcome results
None listed