Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer
Study Details
Study Description
Brief Summary
Concurrent chemoradiotherapy (CRT)
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Radiotherapy 25 ㏉/5 fractions (start concomitantly at D1)
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↓ ↓ ↓ ↓ ↓
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Radical surgery 6 weeks after completion of chemoradiotherapy
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↑ ↑ ↑ ↑ ↑ D1 - - - - - D5
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5-Fluorouracil 400㎎/㎡/day + LV 20㎎/㎡/day IV bolus during the radiotherapy
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: short-course CRT-5FU
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Radiation: Radiation: 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).
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Outcome Measures
Primary Outcome Measures
- To evaluate the pathologic response [After surgery with pathology data]
downstaging(ypT0-2N0M0)rate
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria :
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Pathologically proven diagnosis of adenocarcinoma of the rectum (located within 8㎝ above the anal verge)
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Locally advanced and curatively resectable tumor(cT3-4 classification) evaluated with magnetic resonance imaging(MRI) with or without transrectal ultrasonography(TRUS)
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Age ≥18
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Performance Status(ECOG) 0-2
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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/㎣
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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
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Patient must provide study-specific informed consent prior to study entry
Exclusion Criteria :
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Any evidence of distant metastases(M1)
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Prior invasive malignancy (except non-melanomatous skin cancer and uterine cervical cancer in situ) unless disease free to a minimum of 3 years
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Hereditary rectal cancer; Familial adenomatous polyposis(FAP), Hereditary non-polyposis colorectal cancer(HNPCC), etc.
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Impending obstruction (except the case with colostomy)
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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
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Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
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Unresected synchronous colon carcinoma
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Clinically unresectable rectal cancer
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | National Cancer Center Korea | Goyang-si | Gyeonggi-do | Korea, Republic of | 410-769 |
Sponsors and Collaborators
- National Cancer Center, Korea
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCCCTS-10-458