Two-week Course Versus Conventionally Fractionated Chemoradiotherapy in Rectal Cancer
NCT ID: NCT02484040
Last Updated: 2017-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
370 participants
INTERVENTIONAL
2015-12-31
2021-07-31
Brief Summary
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Detailed Description
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* Radiotherapy, 33 Gy/10 fractions for 2 weeks
↓↓↓↓↓ ↓↓↓↓↓ Radical surgery 6 weeks after completion of chemoradiotherapy D1----------------------D12
* Capecitabine 825 mg/m2, twice daily
1.2 control arm
Standard concurrent chemoradiotherapy (CRT)
* Radiotherapy, 50.4 Gy/28 fractions for 6 weeks
↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓ Radical surgery D1--------------------------------------------------------------------------D38
* Bolus 5-FU, 400 mg/ m2 and leucovorin, 20 mg/ m2 during week 1 and 5
* Capecitabine, 825 mg/ m2, bid
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Two-week course arm
Experimental arm receive 33 Gy in 10 fractions of radiation for 2 weeks with oral capecitabine.
Two-week course of radiation, 33 Gy/10 fx and oral capecitabine, 825 mg/m2, bid
Two-week course of radiation
33 Gy in 10 fractions for 2 weeks
Two-week course of radiation
oral capecitabine, 825mg/m2, bid
Conventional arm
conventionally fractionated radiation of 50.4 Gy/28 fx and 5-FU, 500 mg/m2 and leucovorin, 20 mg/m2 for 5 days, monthly or Capecitabine, 825 mg/m2, bid
No interventions assigned to this group
Interventions
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Two-week course of radiation
33 Gy in 10 fractions for 2 weeks
Two-week course of radiation
oral capecitabine, 825mg/m2, bid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. distal margin of the tumor located \< 10 cm from the anal verge;
3. cT3-4N0-2 classification as determined by magnetic resonance imaging (MRI) and/or endorectal ultrasonography (EUS);
4. no evidence of distant metastasis;
5. Karnofsky performance score over 70;
6. adequate bone marrow, liver, and renal function (leucocytes \>4000/mm3, hemoglobin \>10 g/dL, platelets \>100,000/mm3; serum bilirubin \<1.5 mg/dL, serum transaminase \<2.5 times the upper normal limit; serum creatinine \<1.5 mg/dL).
Exclusion Criteria
2. No complete resection of tumor (R2)
20 Years
80 Years
ALL
Yes
Sponsors
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Jong Hoon Lee
OTHER
Responsible Party
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Jong Hoon Lee
Mr.
Principal Investigators
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Jong Hoon Lee, MD
Role: PRINCIPAL_INVESTIGATOR
St. Vincent's Hospital, The Catholic University of Kora
Locations
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Lee Jong Hoon
Suwon, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Lee JH, Kim JG, Oh ST, Lee MA, Chun HG, Kim DY, Kim TH, Kim SY, Baek JY, Park JW, Oh JH, Park HC, Choi DH, Park YS, Kim HC, Chie EK, Jang HS. Two-week course of preoperative chemoradiotherapy followed by delayed surgery for rectal cancer: a phase II multi-institutional clinical trial (KROG 11-02). Radiother Oncol. 2014 Jan;110(1):150-4. doi: 10.1016/j.radonc.2013.11.013. Epub 2014 Jan 7.
Other Identifiers
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TwoArc trial
Identifier Type: -
Identifier Source: org_study_id
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