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Active, not recruiting Phase 3

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

NCT02843191 · tracked via the Priya Life Science South Korea tracker
Sponsor
Kyung Hee University Hospital at Gangdong
Phase
Phase 3
Started
2016-12-07
Last updated
2024-12-27

Condition(s) studied

Rectal Cancer

Investigational drug(s) / intervention(s)

Chemotherapy

Chemotherapy: 5-FU, Leucovorin, and Oxaliplatin (FOLFOX regimen)

Study summary

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

Eligibility

Sex
ALL
Min age
20 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of mid or low rectum 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: 1. Upper rectal cancer 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

Primary outcome measure(s)

  • Pathologic complete response — 2 years
    Pathologic complete response is defined as no residual tumor on the surgical specimen after chemoradiotherapy. (i.e. Mandard grade 1 or Dworak grade 4)
  • Disease-free survival — 3 years
    The rates of patients who survive without recurrence

Trial sites (14)

FacilityCityRegionStatus
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

More Kyung Hee University Hospital at Gangdong trials in South Korea

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02843191 on ClinicalTrials.gov ↗ ← All trials in South Korea