Rectal cancer
Conditions
Interventions
(1) Chemoradiotherapy:
Capecitabine 1,650 mg/m2/day twice daily after breakfast and dinner for 5 days, followed by 2 days off for 6 weeks.
Radiation (45 Gy/25 whole pelvis + primary tumor boost 5.4
Sponsors
KANEMITSU Yukihide
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Endoscopic biopsy from a primary rectal lesion has been histologically diagnosed as tubular adenocarcinoma (well or moderately differentiated). Or endoscopic biopsy from a primary lesion in the anal canal has been histologically diagnosed as adenocarcinoma (rectal type) and further diagnosed as well differentiated or moderately differentiated. (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-cT3 by abdominal and pelvic contrast CT* and pelvic contrast MRI* with a slice thickness of 5 mm or less. (JSCCR guideline, 9th Edition) *Contrast-enhanced CT or contrast-enhanced MRI are preferred, but plain CT or plain MRI is acceptable, respectively. (5) No lymph node satisfying either 1. or 2. below is present on comprehensive diagnosis by contrast-enhanced CT* of the chest, abdomen, and pelvic region with a slice thickness of 5 mm or less and contrast-enhanced MRI* of the pelvic region. 1. 10 mm or more in short diameter 2. 7 mm or more in short diameter and one or more 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 2. Hemoglobin >= 9.0 g/dL (no blood transfusion within 14 days prior to the date of blood collection for the test used for registration) 3. Platelet count >=100,000/mm3 4. Total bilirubin <= 2.0 mg/dL 5. AST<=100 U/L 6. ALT<=100 U/L 7. Serum creatinine <= 1.5 mg/dL (15) 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 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 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 |
|---|---|
| Phase II : cCR rate at final response evaluation Phase III : Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II part: cCR+nearCR rate at final response evaluation, rectal preservation rate (W&W strategy + local therapy patients), adverse event rate (chemoradiation, consolidation chemotherapy), surgical complication rate, concordance rate between central and each facility in efficacy assessment Phase III part: Progression-free survival, local progression-free survival, rectal preservation survival, 5-year no-stoma survival rate, cCR rate at final response evaluation, cCR + nearCR rate at final response evaluation, concordance rate between central and each facility for efficacy, local regrowth rate of W&W strategy cases, rectal sparing rate (W&W strategy + local resection patients), R0 resection rate in radical surgery cases, adverse event rate (chemoradiotherapy, consolidation chemotherapy), surgical complication rate, anorectal defecation function score (Wexner score), urinary drainage score (I-PSS), sexual function score (IIEF5) | — |
Contacts
Public ContactEriko SATOMI
National Cancer Center Hospital
Outcome results
None listed