Consolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After Neoadjuvant Concurrent Chemoradiotherapy
NCT ID: NCT02843191
Last Updated: 2024-12-27
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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ACTIVE_NOT_RECRUITING
PHASE3
358 participants
INTERVENTIONAL
2016-12-07
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Adjuvant chemotherapy
After neoadjuvant chemoradiotherapy, patients will receive surgery followed by eight cycles of chemotherapy.
Chemotherapy
5-FU, Leucovorin, and Oxaliplatin (FOLFOX regimen)
Consolidation chemotherapy
After neoadjuvant chemoradiotherapy, patients will receive three cycles of chemotherapy. Thereafter, they will receive surgery followed by five cycles of chemotherapy.
Chemotherapy
5-FU, Leucovorin, and Oxaliplatin (FOLFOX regimen)
Interventions
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Chemotherapy
5-FU, Leucovorin, and Oxaliplatin (FOLFOX regimen)
Eligibility Criteria
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Inclusion Criteria
2. Locally advanced rectal cancer confirmed by image (i.e. Magnetic resonance image)
* Clinical stage T1-3N1or2 on MRI
* Clinical stage cT3N0 (or depth of perirectal invasion by tumor \>5mm on MRI)
* Suspicious of circumferential invasion on MRI (or circumferential margin \<1mm)
3. ECOG performance status of 0-2
4. ASA grade ≤ 3
5. An informed consent has been signed by the patient
Exclusion Criteria
2. Clinical stage T1or2N0 on MRI
3. Clinical stage T4Nany on MRI
4. Clinical stage TanyNanyM1 by image or histology
5. The patient received chemotherapy or radiotherapy during the past 6 months
6. The patient received any therapy for colorectal cancer or another malignancy during the past 5 years
7. The patient has severe underlying diseases or poor condition to receive chemotherapy or radiotherapy
8. Pregnant of breastfeeding women
9. The patient who participate in another clinical trial, or receives any drug for the trial
10. Uncontrolled peripheral neuropathy (more than grade 2)
11. Any unhealed wound, fracture, peptic ulcer, or intraabdominal abscess
12. Active gastrointestinal bleeding
13. Patients with an active infection, which needs antibiotic therapy, during the randomization period
20 Years
75 Years
ALL
No
Sponsors
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Korean Society of ColoProctology
UNKNOWN
Pharmbio Korea Inc.
UNKNOWN
Samjin Pharmaceutical Co., Ltd.
INDUSTRY
Boryung Pharmaceutical Co., Ltd
INDUSTRY
JW Pharmaceutical
INDUSTRY
Kyung Hee University Hospital at Gangdong
OTHER
Responsible Party
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Suk-Hwan Lee
Professor
Principal Investigators
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Suk-Hwan Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
892 Dongnam-ro, Gangdong-gu, Seoul, Korea. Kyung Hee University Hospital at Gangdong
Chang Woo Kim, MD, PhD
Role: STUDY_DIRECTOR
164 Worldcup-ro, Yeongtong-gu, Suwon, Korea. Ajou University School of Medicine
Locations
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Inje University Busan Paik hospital
Busan, , South Korea
Soonchunhyang University Cheonan Hospital
Cheonan, , South Korea
Chuncheon Sacred Heart Hospital, Hallym University College of Medicine
Chuncheon, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Wonkwang University Hospital
Iksan, , South Korea
Inje University Sanggye Paik Hospital
Seoul, , South Korea
Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul, , South Korea
Seoul St. Mary's Hospital, The Catholic University College of Medicine
Seoul, , South Korea
Ajou University School of Medicine
Suwon, , South Korea
Uijeongbu St. Mary's Hospital, The Catholic University College of Medicine
Uijeongbu-si, , South Korea
Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine
Wŏnju, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Countries
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References
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Other Identifiers
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KSCP2016
Identifier Type: -
Identifier Source: org_study_id