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
- Diseases
- Colorectal cancer
- 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
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Inje University Busan Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Soonchunhyang University Cheonan Hospital Coordinator of this site? Confirm its status | Cheonan | South Korea | Unknown status |
| Chuncheon Sacred Heart Hospital, Hallym University College of Medicine Coordinator of this site? Confirm its status | Chuncheon | South Korea | Unknown status |
| Keimyung University - Dongsan Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun | South Korea | Unknown status |
| Wonkwang University Hospital Coordinator of this site? Confirm its status | Iksan | South Korea | Unknown status |
| Inje University Sanggye Paik Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul St. Mary's Hospital, The Catholic University College of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Gangnam Severance Hospital, Yonsei University College of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ajou University School of Medicine Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| Uijeongbu St. Mary's Hospital, The Catholic University College of Medicine Coordinator of this site? Confirm its status | Uijeongbu-si | South Korea | Unknown status |
| Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine Coordinator of this site? Confirm its status | Wŏnju | South Korea | Unknown status |
| Pusan National University Yangsan Hospital Coordinator of this site? Confirm its status | Yangsan | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.