Recurrent rectal cancer
Conditions
Interventions
Heavy-ion Particle Radiotherapy
Sponsors
National Institutes for Quantum and Radiological Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.confirmed pelvic recurrence of rectal cancer without distant metastasis 2.had radiographically measurable tumor 3.Age to obtain consent is over 20 yo 4. performance status (ECOG) of 0-2 5. CMP and CBC with adequate hematologic variables as defined by WBC>1000/mm3, platelets>25,000/mm3,Creatinine <1.5 mg/dL,AST and ALT < 2.5 X ULN 6. expected to survive over 3 months 7. All patients must be willing and capable to provide informed consent
Exclusion criteria
Exclusion criteria: 1.Tumor exceeds 15 cm in greatest dimension 2. Subjects receiving other investigational agents they received chemotherapy within 4 weeks of CIRT3. they had an infection at the tumor site 4. The tumor is infiltrating the digestive tract or bladder 5. Prior radiation to the pelvis 6. resectable by radiographic 7. with distant metastasis 8. Active other cancer or within 2 years of disease free period after cancer treatment 9. serious complications 10. difficult to participate in clinical trials because of mental illness 11. Patients who doctors judged that clinical trial participation is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival rate at 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Progression-free survival Toxicity cost-effectiveness Quality-of-life | — |
Countries
Japan
Contacts
Public ContactShigeru Yamada
National Institute of Radiological Sciences Hospital
Outcome results
None listed