lower advanced rectal cancer rectal cancer
Conditions
Interventions
Radical surgery will be performed following preoperative chemoradiotherapy (CRT) with UFT / UZEL + CPT-11, and FOLFOX therapy (3 courses) or CAPOX therapy (2 courses) will be performed in the period b
E02, E04
total neoadjuvant therapy, preoperative chemoradiotherapy, adjuvant chemotherapy
Sponsors
Ishihara Soichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Those who meet all of the following selection criteria are targeted. 1) The below rectum tumor or even if the above rectal tumor reaches the below rectum 2) Cases confirmed to be adenocarcinoma histologically 3) Cases judged to fall under any of the following by preoperative diagnosis using MRI or CT (1) Cases of infiltration into surrounding organs (T4b, anyN) (2) Cases with suspected advanced lymph node metastasis such as lateral lymph node metastasis (3) Cases diagnosed with suspicion of Extramural Venous Invasion (EMVI) 4) Cases without distant organ metastasis 5) Cases of age 20 to 80 years (at the time of obtaining consent) 6) Cases in which radiation therapy, chemotherapy, or hormone therapy is not performed as pretreatment 7) Cases in which food can be ingested and drugs can be orally administered 8) Cases in which the functions of major organs (bone marrow, heart, lungs, liver, kidneys, etc.) are sufficiently maintained: The doctor makes a judgment based on the following values. a. White blood cell count: 4,000 / mm3 and more, and 12,000 / mm3 and less b. Number of neutrophils: 2,000 / mm3 or more c. Platelet count: 100,000 / mm3 or more d. Hemoglobin: 9.0 g / dl or higher e. Total bilirubin: 1.5 mg / dl or less f. AST (GOT) / ALT (GPT): 100 IU / L and less g. Serum creatinine clearance: 60.0 mL / min and more * * If the creatinine clearance by 24-hour urine collection is actually measured, use that value. If there is no measured value, calculate the estimated value using the following Cockcroft-Gault estimation formula Male: creatinine clearance = body weight x (140-age) / (72 x serum creatinine level) Female: creatinine clearance = 0.85 x {weight x (140-age) / (72 x serum creatinine level)} 9) Cases with no abnormal findings on the electrocardiogram (abnormalities without clinical problems are acceptable) 10) Cases with a general performance status (P.S.) of 0 to 1 11) Cases without sensory neuropathy 12) Cases in which the research subject has given written consent to participate in the study
Exclusion criteria
Exclusion criteria: Those who meet any of the following exclusion criteria will be excluded from the target. 1) Cases with a history of drug hypersensitivity 2) Cases where UFT / UZEL is contraindicated 3) Cases where administration of CPT-11 is contraindicated 4) Cases of UGT1A1 *6/*6, UGT1A1 *28/*28 and heterozygotes (UGT1A1*6/*28) 5) Cases where 5-FU administration is contraindicated 6) Cases where administration of LV is contraindicated 7) Cases where L-OHP administration is contraindicated 8) Cases where administration of Capecitabine is contraindicated 9) Cases receiving flucytosine, phenytoin, and potassium warfarin 10) Cases with active infectious diseases (fever 38.0 degree or higher) 11) Cases with serious complications (intestinal palsy, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, poor control or severe diabetes, heart failure, renal failure, liver failure, autoimmune disease, etc.) 12) Cases with diarrhea (more than 4 times a day or watery stool) 13) Patients with clinical brain metastases and cases with a history of brain metastases 14) Cases with simultaneous double cancer or metachronous double cancer with a disease-free period of 5 years or less 15) Pregnant or lactating women, or with the potential (will) to become pregnant 16) Men who wish to have children 17) Other cases that the doctor in charge deems inappropriate as a target
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of adverse events at the end of postoperative adjuvant therapy FOLFOX therapy or CAPOX therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Therapeutic effect a. down-staging rate b. pCR rate c. Dose intensity d. Treatment completion rate (2) Prognosis a. Perioperative safety (incidence of adverse events occurring by 30 days after surgery) b. Local recurrence rate c. Distant metastasis recurrence rate d. Recurrence-free survival e. Overall survival | — |
Contacts
Public ContactShinya Abe
the University of Tokyo Hospital
Outcome results
None listed