Perioperative chemotherapy for locally advanced colorectal cancer.

JRCT ID: jRCTs051180167

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: locally advanced colon cancer
• Date of first enrollment: 16/01/2017
• Target sample size: 35
• Study type: Interventional

Intervention(s)

1) All RAS wild-type: 6 courses of cetuximab+mFOLFOX6 or 4 courses of cetuximab+SOX is performed, followed by curative operarion.
2) All RAS mutant-type: 6 courses of FOLFOXIRI or SOXIRI is performed, followed by curative operation.

Outcome(s)

• Primary Outcome: Response rate (judged by enhanced CT and MRI on 12 weeks after initiation of chemotherapy), Induction rate of curative operation
• Secondary Outcome: Overall survival, Relapse free survival. Incidence rate of adverse event, Postperative complication, Pathological complete response rate.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1) Written informed consent
2) Investigator determines that the appropriate
3) Histologically confirmed colorectal cancer(Excluding the appendix)
4) RAS wild-type or mutant.
5) With measurable lesion
6) Irinotecan case of use UGT1A1 *6 *28 is a wild type or single hetero.
7) Without chemotherapy history (Including the hepatic arterial infusion / radiation therapy). However, with regard to the post-operative adjuvant chemotherapy, to be registered if it passed more than 6 months from the end of treatment.
8) Performance Status (ECOG) 0-2 (Possible outpatient treatment)
9) Age over 20 years
10) Survival period more than 3 months
11) Adequate organ function (Inspection of within 14 days before)
1. WBC: >=3000/mm3 and 12,000/mm3
2. Neutrophil: >=1,500/mm3
3. Platelet: >=100,000/mm3
4. Hemoglobin: >=9.0g/dL
5. T Bil: <=2.0mg/dL
6. AST,ALT: <100IU/L
7. Serum creatinine: <=1.5mg/dL
12) With ability of oral intake

Exclude criteria

1) Patients with severe drug allergy (hypersensitivity)
2) Clinical problem infection
3) Liver dysfunction (jaundice) / Severe renal dysfunction
4) Uncontrolled high blood pressure, Diabetes, Hypercalcemia
5) Severe lung disease (Interstitial pneumonia, Pulmonary fibrosis, Advanced emphysema, etc)
6) Patient who need drainage of peritoneal, pleural or pericardial effusion.
7) Brain metastases (Diarrhea a hindrance to daily life in the patient who has a colostomy)
8) Diarrhea (watery stool)
9) Hepatitis B / C virus-positive
10) In addition, cases in which the investigator or the examination doctor judged it to be inappropriate for this study.

Related Information

• Primary Sponsor: Tokuhara Katsuji
• Secondary ID(s): UMIN000024323