advanced rectal cancer
Conditions
Interventions
S-1:80mg/m2 day1-5, day8-12, day15-19, day22-26, day29-day33 Panitumumab: 6mg/kg day1, day15, day29 Radiation:1.8 Gy of consecutive 5 days total 25 fractions, 45.0 Gy
Sponsors
Juntendo University Faculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with histologically proven rectal (adenocarcinoma) cancer. 2) Meet all of the following cases in less than four weeks prior to registration. Patients who are clinical stage T3-4 by diagnosis (the presence or absence of lymph node metastasis does not matter) The main site the tumor is occupying is Rb. The lower edge of the tumor is within 5cm from the anal verge. 3) Patients it is determined that K-ras gene is wild type by mutation analysis.( For patients with mutant K-ras after obtaining informed consent, preoperative chemoradiotherapy combined TS-1 is to conducted for usual treatment.) 4) Patients with no liver metastasis, peritoneal metastasis, and distant metastases. 5) Patients over 20 years of age at registration. 6) Patients who have not been conducted before treatment (radiation therapy, chemotherapy, etc.) against the target site. 7) Patients with adequate main organ function. (To meet all of the following within 14 days prior to the registration.) WBC >=4,000/mm3 Neutrophil count >=2,000/mm3 Platelet count >=100,000/mm3 Hemoglobin >= 9.0 g / dl Total bilirubin <= 1.5 mg / dl (GPT) (GOT); ALT AST <= 2 x times UNL Serum creatinine <= UNL Estimated creatinine clearance (by the formula of Cockcroft-Gault) at least 50 ml / min 8) Eastern Cooperative Oncology Group performance status of 0 or 1 9) Patients is possible oral administration of drugs and dietary intake. 10) Patient was explain of this trial and put patient's signature to a document.
Exclusion criteria
Exclusion criteria: 1) Patients with a history of serious drug allergy. 2) Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ. 3) Patiens receiving flucytosine (a pyrimidine system antifungal agent fluoride). 4) Patients with active infection (fever over 38). 5) Patients with serious complications (intestinal paralysis, intestinal obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes, uncontrolled hypertension, heart failure, renal failure, liver failure, etc.) 6) Patients with a history of interstitial pneumonia. 7) Patients with ascites, pleural effusion requiring treatment. 8) Patients with gastrointestinal bleeding. 9) Patients with diarrhea. 10) Patients with perforation, penetration. 11) Women with (making) the possibility of pregnancy, pregnant or lactating women. Patients with no intention to contraception. 12) Any other cases who are regarded as inadequate for study enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission (PCR) rate, Overall survival, Relapse free survival | — |
Countries
Japan
Contacts
Public ContactMasaki Hata
Juntendo University Faculty of Medicine Department of Coloproctological Surgery
Outcome results
None listed