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NCT02843191Active, not recruitingPhase 3

Consolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After Neoadjuvant Concurrent Chemoradiotherapy

KCSP Trial of CONsolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After NeoadjUvant Concurrent ChemoraDiothErapy: a Multicenter, Randomized Controlled Trial (KONCLUDE)

Source: ClinicalTrials.gov · Last updated 27 Dec 2024

Brief summary (registry, in English)

This trial is to assess the efficacy and feasibility of consolidation chemotherapy after neoadjuvant chemoradiotherapy for locally advanced mid or low rectal cancer.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
358 (actual)
First submitted
19 Jul 2016
Start date
7 Dec 2016
Primary completion date
15 Jul 2023
Lead sponsor
Kyung Hee University Hospital at Gangdong
NCT number
NCT02843191

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 358
  • From 7 Dec 2016 to the primary completion date, 15 Jul 2023
  • 14 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The patient received chemotherapy or radiotherapy during the past 6 months
  • The patient received any therapy for colorectal cancer or another malignancy during the past 5 years
  • The patient who participate in another clinical trial, or receives any drug for the trial

Other illness

  • Upper rectal cancer
  • The patient has severe underlying diseases or poor condition to receive chemotherapy or radiotherapy
  • Any unhealed wound, fracture, peptic ulcer, or intraabdominal abscess
  • Active gastrointestinal bleeding
  • Patients with an active infection, which needs antibiotic therapy, during the randomization period

Other

  • Clinical stage T1or2N0 on MRI
  • Clinical stage T4Nany on MRI
  • Clinical stage TanyNanyM1 by image or histology
  • Pregnant of breastfeeding women
  • Uncontrolled peripheral neuropathy (more than grade 2)

Who the study is looking for

  • Histologically confirmed adenocarcinoma of mid or low rectum
  • 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)
  • ECOG performance status of 0-2
  • ASA grade ≤ 3
  • An informed consent has been signed by the patient

Age in the registry: 20 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Inje University Busan Paik Hospital
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BusanSouth KoreaUnknown status
Soonchunhyang University Cheonan Hospital
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CheonanSouth KoreaUnknown status
Chuncheon Sacred Heart Hospital, Hallym University College of Medicine
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ChuncheonSouth KoreaUnknown status
Keimyung University - Dongsan Medical Center
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DaeguSouth KoreaUnknown status
Chungnam National University Hospital
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DaejeonSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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HwasunSouth KoreaUnknown status
Wonkwang University Hospital
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IksanSouth KoreaUnknown status
Inje University Sanggye Paik Hospital
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SeoulSouth KoreaUnknown status
Seoul St. Mary's Hospital, The Catholic University College of Medicine
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SeoulSouth KoreaUnknown status
Gangnam Severance Hospital, Yonsei University College of Medicine
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SeoulSouth KoreaUnknown status
Ajou University School of Medicine
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SuwonSouth KoreaUnknown status
Uijeongbu St. Mary's Hospital, The Catholic University College of Medicine
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Uijeongbu-siSouth KoreaUnknown status
Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine
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WŏnjuSouth KoreaUnknown status
Pusan National University Yangsan Hospital
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YangsanSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.