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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02843191

Enrollment

358

Registered

2016-07-25

Start date

2016-12-07

Completion date

2026-06-30

Last updated

2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

Rectal Cancer, Consolidation Chemotherapy

Brief summary

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

Interventions

DRUGChemotherapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Secondary

Measure	Time frame	Description
Tumor response rate	2 years	Amount of tumor regression after surgery according to the guideline including Mandard or Dworak
Radiotherapy-related complications	2 years	Complications according to the CTCAE 4.0
Peripheral neuropathy	3 years	Peripheral neuropathy will be evaluated as grade 1 to 4 according to NCI CTCAE 4.0.
Postoperative complications	2 years	Complications after surgery
R0 resection	2 years	R0 resection is defined as resection without remnant tumor, whereas R1 resection as microscopic residual tumor and R2 resection as gross residual tumor. R0 resection will be proven histologically as no resection margin involvement of tumor.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026