Rectal cancer
Conditions
Interventions
Radiotherapy with fractions of 1.8 Gy/day, given 5 days per week for 25days. The total dose of radiation will be 45 Gy. S-1 will be given orally two times per day on Days 1-5, 8-12, 15-19, 22-26, 29
Sponsors
Department of frontier surgery Graduate school of medicine, Chiba University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1). Histopathologically confirmed as rectal cancer (adenocarcinoma) 2). diagnosed as partial advance lower rectal cancer (adenocarcinoma) 3). without distant metastases 4). Clinical stage T3 or T4, and/or lymph node positive. 5). treatment is not enforced before the radiation exposure in chemotherapy or the pelvis from head to foot. 6). Age at the time of the registration is a case 20 years or older 7). Eastern Cooperative Oncology Group performance status 0-1 8). more than three months than the treatment starting date is expected 9). a main organ (marrow, lungs, liver, kidney) does not have a high obstacle 10). organ functions are secured for less than 14 days before registration by inspection of (possible as for the inspection of the same day two weeks before the registration day) (1) leukocytes: Less than more than 4,000 /mm3 and 12,000 /mm3 (2) neutrophils: More than 2,000 /mm3 (3) platelets: More than 100,000 /mm3 (4) haemoglobin: More than 9.0 g/dL (5) AST(GOT)/ALT(GPT): 100IU/L or less (6) total bilirubin: Lower than 1.5 mg/dL (7) creatinine clearance: More than 60 mL/min 11). Ability to ingestion intake and drug administration orally. 12). Informed consent is obtained.
Exclusion criteria
Exclusion criteria: 1). Even if is an overlap cancer case of the activity or heterochrony; a treatment-free and disease-free period the case (but cancer in the epithelium and the skin cancer are excluded) less than five years 2). It is a case with a history of the radiation therapy including the irradiation after art for a lesion 3). with the diarrhea (water-like flight) 4). receiving flucytosine 5). It is a case with the past of hypersensitivity for S-1, an ingredient of celecoxib 6). The case (diabetes having poor heart, kidney, liver failure, control) with serious complications 7). Aspirin asthma or a case with the past 8). with peptic ulcer of the activity 9). uses an NSAID regularly 10). hydrothorax, abdominal dropsy to need urgent treatment 11). having an infectious disease of the activity few for tumor in itself 12). having the intestinal tract paralysis, ileus 13). with the possibility (intention) of the pregnancy, a pregnant woman or a nursing girl, a case without the intention to prevent conception 14). A perioperative patient of the coronary bypass rebuilding art 15). In addition, the case that I judged to be inappropriate though the examination medical attendant carried out the final examination safely
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD and RD are determined by Phase I part. Histopathological effect are primary endpoint of Phase II part. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I part: Histopathological effect Phase II part: Response rate, Progression-free survival, Overall survival, Rate of adverse events, R0 resection, sphincter preserving, Down Staging, value of COX2 expression for tumor regression | — |
Countries
Japan
Contacts
Public ContactGaku Ohira
Graduate school of medicine, Chiba University Department of frontier surgery
Outcome results
None listed