Table 1 Inclusion and exclusion criteria

1)

A tumor located below the peritoneal reflection or a rectal tumor reaching the peritoneal reflection

1)

Patients with a history of drug hypersensitivity

2)

Patients with histologically confirmed adenocarcinoma

2)

Patients for whom UFT/UZEL is contraindicated

3)

Patients judged to fall under any of the following by a preoperative diagnosis using MRI or CT

3)

Patients for whom the administration of CPT-11 is contraindicated

(1) Infiltration into the surrounding organs (T4b, any N)

4)

Patients with UGT1A1*6/*6, UGT1A1*28/*28, and heterozygotes (UGT1A1*6/*28)

(2) Suspected advanced lymph node metastasis, such as lateral lymph node metastasis

5)

Patients for whom the administration of 5-FU is contraindicated

(3) Suspected extramural venous invasion

6)

Patients for whom the administration of LV is contraindicated

4)

Patients without distant organ metastasis

7)

Patients for whom the administration of L-OHP is contraindicated

5)

Patients aged between 20 and 80 years (at the time of obtaining consent)

8)

Patients for whom the administration of capecitabine is contraindicated

6)

Patients in whom radiation therapy, chemotherapy, or hormone therapy has not been performed as a pretreatment

9)

Patients receiving flucytosine, phenytoin, and potassium warfarin

7)

Patients who ingest food and may be orally administered drugs

10)

Patients with active infectious diseases (fever 38.0 °C or higher)

8)

Patients in whom the functions of the major organs are sufficiently maintained.

11)

Patients with serious complications

The doctor will make a judgment based on the following values:

12)

Patients with diarrhea (more than 4 times a day or watery stools)

a. White blood cell count: 4,000/mm³ and higher, and 12,000/mm³ and lower

13)

Patients with clinical brain metastases and those with a history of brain metastases

b. Number of neutrophils: 2,000/mm³ or higher

Patients with simultaneous double cancer or metachronous double cancer with a disease-free period of 5 years or less

c. Platelet count: 100,000/mm³ or higher

14)

Pregnant or lactating women or those with the desire to become pregnant

d. Hemoglobin: 9.0 g/dl or higher

15)

Men who wish to have children

e. Total bilirubin: 1.5 mg/dl or lower

16)

Other patients that the doctor in charge deems inappropriate as a target

f. AST (GOT)/ALT (GPT): 100 IU/L and lower

g. Serum creatinine clearance using the Cockcroft-Gault estimation formula: 60.0 mL/min and more

* * If creatinine clearance by 24-hour urine collection is measured, that value is used.

If there is no measured value, calculate the estimated value using the Cockcroft-Gault estimation formula:

Male: creatinine clearance = body weight × (140-age) / (72 × serum creatinine level)

Female: creatinine clearance = 0.85 × {weight × (140-age) / (72 × serum creatinine level)}

9)

Patients with no abnormal electrocardiogram findings (abnormalities without clinical issues are acceptable)

10)

Patients with an Eastern Cooperative Oncology Group Performance Status of 0 to 1

11)

Patients without sensory neuropathy

12)

The research subject has given written consent to participate in the study