Rectal cancer Lower rectal cancer
Conditions
Interventions
Chemoradiotherapy followed by consolidation chemotherapy
Chemoradiotherapy
Radiotherapy:45-50.4Gy in 25-28 fractions (5 fractions per week) to the pelvis.
Chemotherapy: Capecitabine according to the b
Chemoradiotherapy, Chemotherapy, Adjuvant
Chemoradiotherapy, Consolidation chemotherapy
Sponsors
Miura Takuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed rectal adenocarcinoma 2) Tumor lower margin is located at lower rectum or anal canal (Rb or P) and palpable by digital examination 3) High resolution MRI examination is possible and the risk factor of recurrence is noted greater than 5mm spread from mucularis propria, lymph node metastasis, positive EMVI, positive CRM, positive intersphincteric plane 4) No distant metastases 5) Eastern Cooperative Oncology Group performance status (PS) 0-1 6) Aged 20 years and older 7) Adequate hematological, hepatic, renal and metabolic function parameters 8) Written informed concent
Exclusion criteria
Exclusion criteria: 1) Tumor lower margin is located at middle rectum (Ra) and not palpable by digital examination 2) Distant metastasis 3) MRI contraindications (Pace maker, cerebral artery clipping etc.) 4) Myelosuppresion (neutrophil count < 1,500/mm3, platlet count < 100,000/mm3) 5) Serious renal dysfunction (Creatinine Clearance < 30mL/min) 6) History of chemotherapy fot rectal cancer 7) History of radiotheraphy to the pelvic region 8) Known allergic reactions on study medication 9) Major surgery within the last 4 weeks prior to enrolment 10) Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, congestive heart failure, brain stroke, pulmonary embolism, etc.) within the last 6 months before enrolment 11) Serious concurrent diseases (incl. Interstitial pneumoniae, pulmonary fibrosis, severe liver function disorders, active and uncontrolled infections, etc.) 12) Pregnant or lactating women, women who are capable of pregnancy and intend to get pregnant or men who want to get their partners pregnant 13) Physician will determine that the patient is inappropriate participate in this trail for the safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 2 year clinical complete response rate, local regrowth rate, non-regrowth disease-free survival, overall survival, pathological complete response rate, down-staging rate, R0 rate, local recurrence rate after rectal resection, disease-free survival after rectal resection, defecation QOL, urination QOL, rate of definitive stoma | — |
Contacts
Public ContactTakuya Miura
Hirosaki University Hospital
Outcome results
None listed