Rectal Cancer
Conditions
Keywords
rectal cancer, short-course, chemoradiotherapy
Brief summary
Concurrent chemoradiotherapy (CRT) * Radiotherapy 25 ㏉/5 fractions (start concomitantly at D1) * ↓ ↓ ↓ ↓ ↓ * Radical surgery 6 weeks after completion of chemoradiotherapy * ↑ ↑ ↑ ↑ ↑ D1 - - - - - D5 * 5-Fluorouracil 400㎎/㎡/day + LV 20㎎/㎡/day IV bolus during the radiotherapy
Detailed description
Radiotherapy using tomotherapy is delivered in 5 Gy daily fractions for a total of 25 Gy in 5 fractions. A bolus injection of 5-fluorouracil (400 mg/m2/d)and leucovorin (20 mg/m2/d) is delivered concurrently on day 1-5 during radiotherapy. Total mesorectal excision is performed within 6±2 weeks. The pathological response of downstaing is the study endpoint.
Interventions
RADIATIONRadiation: short-course preoperative chemoradiotherapy
Drug: 5-Fluorouracil 5-Fluorouracil is administered intravenously at a dose of 400 mg/m2 once daily continuous regimen during RT(5 days). Radiation: Localization, simulation and immobilization Radiation dose and planning Total dose 25Gy, 5 fractions (5 Gy/day).
Sponsors
National Cancer Center, Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * Pathologically proven diagnosis of adenocarcinoma of the rectum (located within 8㎝ above the anal verge) * Locally advanced and curatively resectable tumor(cT3-4 classification) evaluated with magnetic resonance imaging(MRI) with or without transrectal ultrasonography(TRUS) * Age ≥18 * Performance Status(ECOG) 0-2 * CBC/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: Hemoglobin ≥ 10 g/dl, Absolute neutrophil count(ANC) ≥ 1,500 cells/㎣, Platelets ≥ 100,000cells/㎣ * Metabolic panel within 14 days prior to registration on study, with adequate liver and renal function defined as follows: AST and ALT ≤ 60 IU/L, bilirubin ≤ 1.5 mg/dl, serum creatinine ≤ 1.5 mg/dl * Patient must provide study-specific informed consent prior to study entry
Exclusion criteria
: * Any evidence of distant metastases(M1) * Prior invasive malignancy (except non-melanomatous skin cancer and uterine cervical cancer in situ) unless disease free to a minimum of 3 years * Hereditary rectal cancer; Familial adenomatous polyposis(FAP), Hereditary non-polyposis colorectal cancer(HNPCC), etc. * Impending obstruction (except the case with colostomy) * Severe, active comorbidity inappropriate to CRT as follows; Acute bacterial or fungal infection, transmural myocardial infarction within the last 6 months, unstable arrhythmia, angina and/or congestive heart failure, unstable arrhythmia * Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception * Unresected synchronous colon carcinoma * Clinically unresectable rectal cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the pathologic response | After surgery with pathology data | downstaging(ypT0-2N0M0)rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor regression grade & MR volumetry | After surgery with pathology data for TRG, at the pretreatment work-up and 1-4 days befor surgery | To evaluate the tumor regression grade & MR volumetry |
| Acute/ late toxicities | preoperative CCRT to 3 months after surgery | To evaluate the acute and late toxicities |
Countries
South Korea
Outcome results
None listed