JCOG2304: A randomized controlled trial comparing transverse colectomy with extended right hemicolectomy for Stage II/III transverse colon cancer (TACTICS)
JCOG2304: A randomized controlled trial comparing transverse colectomy with extended right hemicolectomy for Stage II/III transverse colon cancer (TACTICS)
INOMATA Masafumi
Oita University Hospital
1-1 Idai-ga-oka, Hasama-machi, Yufu City, Oita 879-5593, Japan
+81-97-586-5842
inomata@oita-u.ac.jp
AKAGI Tomonori
Oita University Hospital
1-1 Idai-ga-oka, Hasama-machi, Yufu City, Oita 879-5593, Japan
+81-97-586-5843
tomakagi@oita-u.ac.jp
Recruiting
Nov. 12, 2024
510
Interventional
randomized controlled trial
open(masking not used)
active control
parallel assignment
treatment purpose
The first registration inclusion criteria
(1) Endoscopic biopsy from a primary colorectal lesion has been histologically diagnosed as adenocarcinoma according to the 9th edition of the Japanese Classification of Colorectal Tumors (papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma, mucinous carcinoma, signet ring cell carcinoma, medullary carcinoma).
(2) The tumor is predominantly located in the transverse colon (T).
(3) Comprehensive diagnosis of cStage II/III by chest-abdominal pelvis contrast CT.
(4) The tumor's responsible blood vessel satisfies both (i) and (ii) in the following abdominal and pelvic CT scan with a slice thickness of 1.25 mm or less.
(i) The responsible blood vessel for the tumor is the middle colonic artery.
(ii) The responsible blood vessel is classified as type a or type b, depending on the position of the tumor and the dominant artery.
(5) No evidence of advanced organ invasion on abdominal and pelvic contrast CT.
(6) No enlarged lymph nodes (short diameter 10 mm or more, short diameter 7 mm or more with irregular margins/internal heterogeneity/oval shape) are seen in the area other than the middle colonic artery region (221, 222rt, 222lt, 223) on CT of the abdomen and pelvis with slice thickness of 1.25 mm or less.
(7) Comprehensive diagnosis using colonoscopy and imaging studies (barium enema, abdominal/pelvic contrast CT, or CT colonography) does not reveal multiple carcinomas. However, cTis and cT1a (cancer is expected to remain in the submucosal layer and invade less than 1,000 micrometre) lesions that are expected to be curatively resectable by endoscopic resection are not considered multiple carcinomas.
(8) Aged 18 to 80 years old on the day of the registration.
(9) Performance status of ECOG is 0 or 1.
(10) No history of intestinal resection.
(11) No intestinal obstruction requiring decompression treatment or perforation. If the intestinal obstruction has been relieved by the insertion of an ileus tube, transanal drainage tube, or stent for intestinal obstruction, registration is possible.
(12) No history of chemotherapy for the underlying disease.
(13) No history of radiation therapy to the abdomen, including treatment for other types of cancer.
(14) Based on the patient's medical history, he does not have familial adenomatous polyposis (FAP) or Lynch syndrome.
(15) The latest blood examination result within 28 days prior to the first registration (the same day of the week 4 weeks before the registration is acceptable) meets all of the following.
(i) neutrophil count >= 1,500/mm3
(ii) Platelet count >= 100,000/mm3
(iii) Total bilirubin <= 2.0 mg/dL
(iv) AST <=100 U/L
(v) ALT<=100 U/L
(vi) Serum creatinine <= 1.5 mg/dL
(16) Written consent to participate in the study has been obtained from the patient.
The second registration inclusion criteria
(1) Primary registration for this test and secondary registration within 28 days of the primary registration date (up to the same day of the week four weeks later is acceptable).
(2) No liver metastasis or peritoneal dissemination was observed during abdominal cavity observation.
(3) No other findings suggest lymph node metastasis outside the area of the middle colonic artery.
(4) R0 resection is judged to be possible.
(1) Active multiple cancers (simultaneous multiple cancers and multiple cancers with a disease-free interval of 5 years or less. However, multiple cancers do not include stage I prostate cancer, stage 0 or stage I laryngeal cancer that has had a complete response to radiotherapy, or cancer that has been completely resected with a 5-year relative survival rate equivalent to 95% or greater).
(2) Infectious diseases requiring systemic treatment.
(3) Have a fever of 38.0 degrees Celsius or higher at the time of registration.
(4) Pregnant, possibly pregnant, within 28 days postpartum, or lactating. Males whose partners wish to become pregnant.
(5) Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and make it difficult for them to participate in the study.
(6) Receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive drugs.
(7) Complicated with unstable angina (angina with onset or worsening within the last 3 weeks) or a history of myocardial infarction within the last 6 months.
(8) Poorly controlled valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
(9) Has one or more of the following complications diagnosed by chest CT: interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
18age old over
80age old under
Both
Transverse colon cancer
Arm A: Extended right hemicolectomy
Arm B: Transverse colectomy
Recurrence-free survival
Overall survival, disease-free survival, incidence of surgical complications, incidence of serious adverse events, number of bowel movements (daytime, night time), number of fecal incontinence episodes, PRO-CTCAE (abdominal distension, abdominal pain), anal defecation function score (Wexner score, LARS score).
