Clinical Trials in South Korea / NCT02843191
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
Other trials for the same condition
The SMART Trial: Modified Single-Stapled Anastomosis in Laparoscopic or Robotic Low Anterior Resection for Rectal Cancer
Enrolling by invitation
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