Rectal cancer
Conditions
Interventions
Arm A: Surgery (TME + lateral lymphadenectomy) + adjuvant chemotherapy
(1) Surgical therapy: total mesorectal excision (TME) and bilateral lateral lymph node dissection (LLND).
(2) Postoperative adjuv
Sponsors
OHUE Masayuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Endoscopic biopsy from a primary rectal lesion has been histologically diagnosed as adenocarcinoma, (papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma, mucinous carcinoma, signet ring cell carcinoma, medullary carcinoma) or adenosqamous cell carcinoma. Or endoscopic biopsy from a primary lesion in the anal canal has been histologically diagnosed as adenocarcinoma (rectal type) or adenosquamous cell carcinoma. (2) The tumor is predominantly located in the upper rectum (Ra), lower rectum (Rb), or anal canal (P). (3) The lower margin of the tumor is located between the perineal reflection and the anal verge (Rb-P). (4) Comprehensive diagnosis of cT2-cT4b by abdominal and pelvic CT* and pelvic MRI*. Among cT4b, cases with suspected organ infiltration of one or more of the following are excluded. (a) Trigone of bladder, (b) urethra, (c) sacrum. *Contrast-enhanced CT or contrast-enhanced MRI are preferred, but plain CT or plain MRI is acceptable, respectively. (5) Lymph node satisfying at least one of (i) - (iii) is present on comprehensive diagnosis by CT* of the chest, abdomen, and pelvic region with a slice thickness of 1.25 mm or less and MRI* of the pelvic region with a slice thickness of 5mm or less. (i) 10 mm or more in short diameter (ii) 7 mm or more in short diameter and one or mor e of the following (a)-(c). (a) Irregular margins (b) MRI shows internal inhomogeneous low-signal areas (c) Circular (long to short diameter ratio = 1,500/mm3 3. Platelet count >= 100,000/mm3 4. Total bilirubin = 30 mL/min (13) Written consent to participate in the study has been obtained from the patient.
Exclusion criteria
Exclusion criteria: (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 po stpartum, or lactating. Males whose partners wish to become pregnant. Female who wish to become pregnant in the future. Female who cannot tolerate early menopause with radiation therapy. (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 poorly controlled diabetes mellitus. (8) Patient has uncontrolled hypertension. (9) 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. (10) Poorly controlled valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. (11) HBs antigen positive. (12) HIV antibody positive. (13) Has one or more of the following complications diagnosed by chest CT: interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival, progression-free survival, local progression-free survival, proportion of patients with R0 resection, response rate of total neoadjuvant therapy (arm B only), proportion of patients with pathological complete response (arm B only), proportion of patients without combined resection of other organ, anal preservation rate, anal preservation rate without stoma, protocol treatment completion rate, TNT completion rate (arm B only), adjuvant chemotherapy completion rate (arm A only), adverse event rate, severe adverse event rate, surgical complication rate, anorectal defecation function score (Wexner score, LARS score), urinary drainage score (I-PSS), sexual function score (IIEF-5) | — |
Contacts
Public ContactMasayuki OHUE
Osaka International Cancer Institute
Outcome results
None listed