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

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

Official Title
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KCSP Trial of cONsolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After neoadjUvant Concurrent chemoraDiothErapy: A Multicenter, Randomized Controlled Trial (KONCLUDE Trial)

Conditions
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Rectal Cancer

Intervention / Treatment
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* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Upper rectal cancer Clinical stage T1or2N0 on MRI Clinical stage T4Nany on MRI Clinical stage TanyNanyM1 by image or histology 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 has severe underlying diseases or poor condition to receive chemotherapy or radiotherapy Pregnant of breastfeeding women The patient who participate in another clinical trial, or receives any drug for the trial Uncontrolled peripheral neuropathy (more than grade 2) 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adjuvant chemotherapy<br>After neoadjuvant chemoradiotherapy, patients will receive surgery followed by eight cycles of chemotherapy. | Drug: Chemotherapy<br>* 5-FU, Leucovorin, and Oxaliplatin (FOLFOX regimen)<br>|
| Experimental: Consolidation chemotherapy<br>After neoadjuvant chemoradiotherapy, patients will receive three cycles of chemotherapy. Thereafter, they will receive surgery followed by five cycles of chemotherapy. | Drug: Chemotherapy<br>* 5-FU, Leucovorin, and Oxaliplatin (FOLFOX regimen)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiotherapy-related complications | Complications according to the CTCAE 4.0 | 2 years | 
| R0 resection | 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. | 2 years | 
| Tumor response rate | Amount of tumor regression after surgery according to the guideline including Mandard or Dworak | 2 years | 
| Postoperative complications | Complications after surgery | 2 years | 
| Peripheral neuropathy | Peripheral neuropathy will be evaluated as grade 1 to 4 according to NCI CTCAE 4.0. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal Cancer, Consolidation Chemotherapy